Bruce Jancin

SAN DIEGO – Physicians overall are doing a less than stellar job of recognizing glucocorticoid-induced osteoporosis and prescribing bone-protective medications for affected or high-risk patients.

But some specialties are doing significantly better than others.

“While many rheumatologists and endocrinologists are doing a pretty good job, we know that collectively, internationally, this still continues to be a major therapeutic dilemma, and steroids still constitute the most common form of drug-induced osteoporosis,” said Dr. Kenneth G. Saag.

He cited a recent as-yet-unpublished study led by University of Alabama epidemiologist Ryan C. Outman, who, together with his coinvestigators, analyzed 106,310 patients in the Medco Pharmacy database who were at high risk for glucocorticoid-induced osteoporosis (GIOP) by virtue of having received more than 90 days of systemic corticosteroid therapy during the study years of 2004-2007.

The primary study outcome was prescription of any form of anti-GIOP medication within 12 months after patients reached the 90-day mark of steroid therapy. The 12-month mark is the point on the therapeutic time line when, according to American College of Rheumatology guidelines, physicians are supposed to initiate bone-protective therapy.

The steroids were prescribed by a total of 53,766 physicians. During the 12-month window, the physicians ordered bone mineral density tests in just 4.6% of the patients, and 23.5% of patients received a prescription for an anti-GIOP medication, according to Dr. Saag, professor of medicine and epidemiology at the University of Alabama, Birmingham.

The results varied by physician specialty. In a multivariate analysis adjusted for patient age, gender, and other potential confounders, endocrinologists were 61% more likely to prescribe anti-GIOP medication for patients having more than 90 days of exposure to systemic steroids than were internists, who served as the reference standard. Rheumatologists were 59% more likely than internists to prescribe therapy.

Nephrologists, pulmonologists, and gastroenterologists were 37%, 34%, and 15%, respectively, more likely to have prescribed bone-protective medications for their at-risk patients than were internists.

Dermatologists and physicians in all other specialties who prescribed steroids for longer than 90 days were, collectively, 22% less likely to introduce anti-GIOP therapy than were internists.

Rates of prescription of anti-GIOP medications were particularly low in men of all ages and in premenopausal women. During the 12 months after more than 90 days of exposure to systemic steroids, 36.8% of affected women aged 50 years or older were prescribed bone-protective medication, compared with 11.4% of affected women under age 50 years and 14.7% of men of any age, said Dr. Saag, who was not involved in the study.

“We've got a lot of work to do in terms of initiating therapy, but adherence is a big problem, too. Less than half of patients who start on any bone-protective drug are still taking it a year later,” he said.

Dr. Saag disclosed that he has received research grants from and serves as a paid consultant to Amgen, Eli Lilly, Merck, and Novartis.

SAN DIEGO – Physicians overall are doing a less than stellar job of recognizing glucocorticoid-induced osteoporosis and prescribing bone-protective medications for affected or high-risk patients.

But some specialties are doing significantly better than others.

“While many rheumatologists and endocrinologists are doing a pretty good job, we know that collectively, internationally, this still continues to be a major therapeutic dilemma, and steroids still constitute the most common form of drug-induced osteoporosis,” said Dr. Kenneth G. Saag.

He cited a recent as-yet-unpublished study led by University of Alabama epidemiologist Ryan C. Outman, who, together with his coinvestigators, analyzed 106,310 patients in the Medco Pharmacy database who were at high risk for glucocorticoid-induced osteoporosis (GIOP) by virtue of having received more than 90 days of systemic corticosteroid therapy during the study years of 2004-2007.

The primary study outcome was prescription of any form of anti-GIOP medication within 12 months after patients reached the 90-day mark of steroid therapy. The 12-month mark is the point on the therapeutic time line when, according to American College of Rheumatology guidelines, physicians are supposed to initiate bone-protective therapy.

The steroids were prescribed by a total of 53,766 physicians. During the 12-month window, the physicians ordered bone mineral density tests in just 4.6% of the patients, and 23.5% of patients received a prescription for an anti-GIOP medication, according to Dr. Saag, professor of medicine and epidemiology at the University of Alabama, Birmingham.

The results varied by physician specialty. In a multivariate analysis adjusted for patient age, gender, and other potential confounders, endocrinologists were 61% more likely to prescribe anti-GIOP medication for patients having more than 90 days of exposure to systemic steroids than were internists, who served as the reference standard. Rheumatologists were 59% more likely than internists to prescribe therapy.

Nephrologists, pulmonologists, and gastroenterologists were 37%, 34%, and 15%, respectively, more likely to have prescribed bone-protective medications for their at-risk patients than were internists.

Dermatologists and physicians in all other specialties who prescribed steroids for longer than 90 days were, collectively, 22% less likely to introduce anti-GIOP therapy than were internists.

Rates of prescription of anti-GIOP medications were particularly low in men of all ages and in premenopausal women. During the 12 months after more than 90 days of exposure to systemic steroids, 36.8% of affected women aged 50 years or older were prescribed bone-protective medication, compared with 11.4% of affected women under age 50 years and 14.7% of men of any age, said Dr. Saag, who was not involved in the study.

“We've got a lot of work to do in terms of initiating therapy, but adherence is a big problem, too. Less than half of patients who start on any bone-protective drug are still taking it a year later,” he said.

Dr. Saag disclosed that he has received research grants from and serves as a paid consultant to Amgen, Eli Lilly, Merck, and Novartis.

SAN DIEGO – Physicians overall are doing a less than stellar job of recognizing glucocorticoid-induced osteoporosis and prescribing bone-protective medications for affected or high-risk patients.

But some specialties are doing significantly better than others.

“While many rheumatologists and endocrinologists are doing a pretty good job, we know that collectively, internationally, this still continues to be a major therapeutic dilemma, and steroids still constitute the most common form of drug-induced osteoporosis,” said Dr. Kenneth G. Saag.

He cited a recent as-yet-unpublished study led by University of Alabama epidemiologist Ryan C. Outman, who, together with his coinvestigators, analyzed 106,310 patients in the Medco Pharmacy database who were at high risk for glucocorticoid-induced osteoporosis (GIOP) by virtue of having received more than 90 days of systemic corticosteroid therapy during the study years of 2004-2007.

The primary study outcome was prescription of any form of anti-GIOP medication within 12 months after patients reached the 90-day mark of steroid therapy. The 12-month mark is the point on the therapeutic time line when, according to American College of Rheumatology guidelines, physicians are supposed to initiate bone-protective therapy.

The steroids were prescribed by a total of 53,766 physicians. During the 12-month window, the physicians ordered bone mineral density tests in just 4.6% of the patients, and 23.5% of patients received a prescription for an anti-GIOP medication, according to Dr. Saag, professor of medicine and epidemiology at the University of Alabama, Birmingham.

The results varied by physician specialty. In a multivariate analysis adjusted for patient age, gender, and other potential confounders, endocrinologists were 61% more likely to prescribe anti-GIOP medication for patients having more than 90 days of exposure to systemic steroids than were internists, who served as the reference standard. Rheumatologists were 59% more likely than internists to prescribe therapy.

Nephrologists, pulmonologists, and gastroenterologists were 37%, 34%, and 15%, respectively, more likely to have prescribed bone-protective medications for their at-risk patients than were internists.

Dermatologists and physicians in all other specialties who prescribed steroids for longer than 90 days were, collectively, 22% less likely to introduce anti-GIOP therapy than were internists.

Rates of prescription of anti-GIOP medications were particularly low in men of all ages and in premenopausal women. During the 12 months after more than 90 days of exposure to systemic steroids, 36.8% of affected women aged 50 years or older were prescribed bone-protective medication, compared with 11.4% of affected women under age 50 years and 14.7% of men of any age, said Dr. Saag, who was not involved in the study.

“We've got a lot of work to do in terms of initiating therapy, but adherence is a big problem, too. Less than half of patients who start on any bone-protective drug are still taking it a year later,” he said.

Dr. Saag disclosed that he has received research grants from and serves as a paid consultant to Amgen, Eli Lilly, Merck, and Novartis.

Major Finding: Performing a Cox Maze III procedure to ablate persistent or permanent AF in patients undergoing CABG and/or aortic valve replacement did not increase operative risk. Overall survival through 60 months was 88.5% in the Maze group and 87.5% in control patients without AF undergoing the same types of heart surgery.

Data Source: A retrospective, propensity score–matched, case-control study involving 190 patients undergoing CABG and/or aortic valve replacement, half of whom had atrial fibrillation.

Disclosures: Dr. Ad declared having no financial conflicts.

COLORADO SPRINGS – Adding the Cox Maze III procedure to eliminate persistent or permanent atrial fibrillation in patients presenting for coronary artery bypass graft or aortic valve surgery does not increase operative risk and may improve long-term outcomes, according to a case-control study.

The import of this finding lies in the fact that many surgeons are reluctant to add an atrial fibrillation (AF) procedure on top of what they see as the main event – that is, the CABG and/or aortic valve replacement.

Indeed, roughly 75% of patients with AF who undergo CABG leave the operating room with their persistent AF left untreated, even though European and American studies suggest that such patients have reduced survival, Dr. Niv Ad said at the meeting.

He presented a propensity score– matched, case-control study that showed there was not only no increase in major morbidity as a result of performing an add-on Cox Maze III procedure, but the 5-year survival rate was closely similar to that of control patients without AF undergoing the same types of heart surgery.

“It means that by treating atrial fibrillation and restoring sinus rhythm, we may restore survival,” observed Dr. Ad, chief of cardiac surgery and director of cardiac surgery research at Inova Heart and Vascular Institute in Falls Church, Va.

“The Cox Maze III should not be denied because of the perceived increased operative risk in patients in whom the cardiac surgical procedure does not include atriotomies, as it may actually significantly improve their outcome,” he said. “With the cardiopulmonary bypass measures we have today and the cardioplegia we have today, I think adding 30-45 minutes of bypass time is not as big a deal as it was 10 years ago.”

Dr. Ad presented a retrospective study including 95 patients who underwent CABG and/or aortic valve replacement plus a Cox Maze III procedure to surgically ablate their AF, along with 95 propensity score–matched controls without AF who underwent similar operations without a Maze.

The median length of hospital stay was 6 days in the Maze group and significantly shorter, at 5 days, in controls. The two groups had similarly low rates of major morbidities, including stroke, infection, reoperation for bleeding, renal failure requiring dialysis, and readmission within 30 days. However, 6% of the Maze group required implantation of a pacemaker, compared with none of the controls, a significant difference.

Dr. Ad minimized the import of this finding. “It's not a major morbidity. The patients are otherwise doing fine.”

Overall survival through 60 months of follow-up was 88.5% in the Maze group and 87.5% in controls. Quality of life as measured using the Short Form–12 and Health-Related Quality of Life instrument improved to a similarly significant degree in both groups.

Regarding which cardiac surgery patients with AF he thinks are most or least likely to benefit from an add-on Cox Maze III procedure, Dr. Ad said, “Based upon my experience, the sicker the patient the more beneficial the Maze procedure. You can really restore AV synchrony and pacing.”

Major Finding: Performing a Cox Maze III procedure to ablate persistent or permanent AF in patients undergoing CABG and/or aortic valve replacement did not increase operative risk. Overall survival through 60 months was 88.5% in the Maze group and 87.5% in control patients without AF undergoing the same types of heart surgery.

Data Source: A retrospective, propensity score–matched, case-control study involving 190 patients undergoing CABG and/or aortic valve replacement, half of whom had atrial fibrillation.

Disclosures: Dr. Ad declared having no financial conflicts.

COLORADO SPRINGS – Adding the Cox Maze III procedure to eliminate persistent or permanent atrial fibrillation in patients presenting for coronary artery bypass graft or aortic valve surgery does not increase operative risk and may improve long-term outcomes, according to a case-control study.

The import of this finding lies in the fact that many surgeons are reluctant to add an atrial fibrillation (AF) procedure on top of what they see as the main event – that is, the CABG and/or aortic valve replacement.

Indeed, roughly 75% of patients with AF who undergo CABG leave the operating room with their persistent AF left untreated, even though European and American studies suggest that such patients have reduced survival, Dr. Niv Ad said at the meeting.

He presented a propensity score– matched, case-control study that showed there was not only no increase in major morbidity as a result of performing an add-on Cox Maze III procedure, but the 5-year survival rate was closely similar to that of control patients without AF undergoing the same types of heart surgery.

“It means that by treating atrial fibrillation and restoring sinus rhythm, we may restore survival,” observed Dr. Ad, chief of cardiac surgery and director of cardiac surgery research at Inova Heart and Vascular Institute in Falls Church, Va.

“The Cox Maze III should not be denied because of the perceived increased operative risk in patients in whom the cardiac surgical procedure does not include atriotomies, as it may actually significantly improve their outcome,” he said. “With the cardiopulmonary bypass measures we have today and the cardioplegia we have today, I think adding 30-45 minutes of bypass time is not as big a deal as it was 10 years ago.”

Dr. Ad presented a retrospective study including 95 patients who underwent CABG and/or aortic valve replacement plus a Cox Maze III procedure to surgically ablate their AF, along with 95 propensity score–matched controls without AF who underwent similar operations without a Maze.

The median length of hospital stay was 6 days in the Maze group and significantly shorter, at 5 days, in controls. The two groups had similarly low rates of major morbidities, including stroke, infection, reoperation for bleeding, renal failure requiring dialysis, and readmission within 30 days. However, 6% of the Maze group required implantation of a pacemaker, compared with none of the controls, a significant difference.

Dr. Ad minimized the import of this finding. “It's not a major morbidity. The patients are otherwise doing fine.”

Overall survival through 60 months of follow-up was 88.5% in the Maze group and 87.5% in controls. Quality of life as measured using the Short Form–12 and Health-Related Quality of Life instrument improved to a similarly significant degree in both groups.

Regarding which cardiac surgery patients with AF he thinks are most or least likely to benefit from an add-on Cox Maze III procedure, Dr. Ad said, “Based upon my experience, the sicker the patient the more beneficial the Maze procedure. You can really restore AV synchrony and pacing.”

Major Finding: Performing a Cox Maze III procedure to ablate persistent or permanent AF in patients undergoing CABG and/or aortic valve replacement did not increase operative risk. Overall survival through 60 months was 88.5% in the Maze group and 87.5% in control patients without AF undergoing the same types of heart surgery.

Data Source: A retrospective, propensity score–matched, case-control study involving 190 patients undergoing CABG and/or aortic valve replacement, half of whom had atrial fibrillation.

Disclosures: Dr. Ad declared having no financial conflicts.

COLORADO SPRINGS – Adding the Cox Maze III procedure to eliminate persistent or permanent atrial fibrillation in patients presenting for coronary artery bypass graft or aortic valve surgery does not increase operative risk and may improve long-term outcomes, according to a case-control study.

The import of this finding lies in the fact that many surgeons are reluctant to add an atrial fibrillation (AF) procedure on top of what they see as the main event – that is, the CABG and/or aortic valve replacement.

Indeed, roughly 75% of patients with AF who undergo CABG leave the operating room with their persistent AF left untreated, even though European and American studies suggest that such patients have reduced survival, Dr. Niv Ad said at the meeting.

He presented a propensity score– matched, case-control study that showed there was not only no increase in major morbidity as a result of performing an add-on Cox Maze III procedure, but the 5-year survival rate was closely similar to that of control patients without AF undergoing the same types of heart surgery.

“It means that by treating atrial fibrillation and restoring sinus rhythm, we may restore survival,” observed Dr. Ad, chief of cardiac surgery and director of cardiac surgery research at Inova Heart and Vascular Institute in Falls Church, Va.

“The Cox Maze III should not be denied because of the perceived increased operative risk in patients in whom the cardiac surgical procedure does not include atriotomies, as it may actually significantly improve their outcome,” he said. “With the cardiopulmonary bypass measures we have today and the cardioplegia we have today, I think adding 30-45 minutes of bypass time is not as big a deal as it was 10 years ago.”

Dr. Ad presented a retrospective study including 95 patients who underwent CABG and/or aortic valve replacement plus a Cox Maze III procedure to surgically ablate their AF, along with 95 propensity score–matched controls without AF who underwent similar operations without a Maze.

The median length of hospital stay was 6 days in the Maze group and significantly shorter, at 5 days, in controls. The two groups had similarly low rates of major morbidities, including stroke, infection, reoperation for bleeding, renal failure requiring dialysis, and readmission within 30 days. However, 6% of the Maze group required implantation of a pacemaker, compared with none of the controls, a significant difference.

Dr. Ad minimized the import of this finding. “It's not a major morbidity. The patients are otherwise doing fine.”

Overall survival through 60 months of follow-up was 88.5% in the Maze group and 87.5% in controls. Quality of life as measured using the Short Form–12 and Health-Related Quality of Life instrument improved to a similarly significant degree in both groups.

Regarding which cardiac surgery patients with AF he thinks are most or least likely to benefit from an add-on Cox Maze III procedure, Dr. Ad said, “Based upon my experience, the sicker the patient the more beneficial the Maze procedure. You can really restore AV synchrony and pacing.”

Major Finding: Exercise ECG stress test showed a sensitivity of 39% for myocardial ischemia in patients with LAFB on their resting ECG, compared with 70% in the patients without LAFB.

Data Source: Retrospective study of 1,403 patients who underwent both maximal treadmill exercise stress ECG test and SPECT myocardial perfusion imaging in search of inducible myocardial ischemia.

Disclosures: Dr. Mousa declared having no financial conflicts.

DENVER – The presence of left anterior fascicular block on a resting ECG indicates an ECG exercise stress test will have significantly diminished diagnostic accuracy, according to a retrospective study.

Thus, this finding on the resting ECG warrants giving serious consideration to adding an imaging modality such as single-photon emission computed tomography (SPECT) myocardial perfusion imaging to the patient's exercise stress test, Dr. Tarek M. Mousa said at the meeting.

He presented a retrospective study of 1,403 patients who underwent both a maximal treadmill exercise stress ECG test and SPECT myocardial perfusion imaging in search of inducible myocardial ischemia. In all, 62 patients (4.4%) had left anterior fascicular block (LAFB) on their resting ECG, including 24 who had both LAFB and right bundle branch block.

The exercise ECG stress test showed greatly reduced sensitivity for myocardial ischemia in patients with LAFB on their resting ECG: 39% as compared with 70% in the 1,341 patients without LAFB.

On the other hand, a finding of greater than 1 mm of exercise-induced ST-segment depression in at least two contiguous leads had significantly greater specificity as an indicator of inducible myocardial ischemia when it occurred in the setting of LAFB: 96% as compared with 79% in controls, added Dr. Mousa of New York Hospital Queens in Flushing.

The presence or absence of right bundle branch block in patients with LAFB on their resting ECG did not affect the diagnostic accuracy of their ECG exercise stress test.

Major Finding: Exercise ECG stress test showed a sensitivity of 39% for myocardial ischemia in patients with LAFB on their resting ECG, compared with 70% in the patients without LAFB.

Data Source: Retrospective study of 1,403 patients who underwent both maximal treadmill exercise stress ECG test and SPECT myocardial perfusion imaging in search of inducible myocardial ischemia.

Disclosures: Dr. Mousa declared having no financial conflicts.

DENVER – The presence of left anterior fascicular block on a resting ECG indicates an ECG exercise stress test will have significantly diminished diagnostic accuracy, according to a retrospective study.

Thus, this finding on the resting ECG warrants giving serious consideration to adding an imaging modality such as single-photon emission computed tomography (SPECT) myocardial perfusion imaging to the patient's exercise stress test, Dr. Tarek M. Mousa said at the meeting.

He presented a retrospective study of 1,403 patients who underwent both a maximal treadmill exercise stress ECG test and SPECT myocardial perfusion imaging in search of inducible myocardial ischemia. In all, 62 patients (4.4%) had left anterior fascicular block (LAFB) on their resting ECG, including 24 who had both LAFB and right bundle branch block.

The exercise ECG stress test showed greatly reduced sensitivity for myocardial ischemia in patients with LAFB on their resting ECG: 39% as compared with 70% in the 1,341 patients without LAFB.

On the other hand, a finding of greater than 1 mm of exercise-induced ST-segment depression in at least two contiguous leads had significantly greater specificity as an indicator of inducible myocardial ischemia when it occurred in the setting of LAFB: 96% as compared with 79% in controls, added Dr. Mousa of New York Hospital Queens in Flushing.

The presence or absence of right bundle branch block in patients with LAFB on their resting ECG did not affect the diagnostic accuracy of their ECG exercise stress test.

Major Finding: Exercise ECG stress test showed a sensitivity of 39% for myocardial ischemia in patients with LAFB on their resting ECG, compared with 70% in the patients without LAFB.

Data Source: Retrospective study of 1,403 patients who underwent both maximal treadmill exercise stress ECG test and SPECT myocardial perfusion imaging in search of inducible myocardial ischemia.

Disclosures: Dr. Mousa declared having no financial conflicts.

DENVER – The presence of left anterior fascicular block on a resting ECG indicates an ECG exercise stress test will have significantly diminished diagnostic accuracy, according to a retrospective study.

Thus, this finding on the resting ECG warrants giving serious consideration to adding an imaging modality such as single-photon emission computed tomography (SPECT) myocardial perfusion imaging to the patient's exercise stress test, Dr. Tarek M. Mousa said at the meeting.

He presented a retrospective study of 1,403 patients who underwent both a maximal treadmill exercise stress ECG test and SPECT myocardial perfusion imaging in search of inducible myocardial ischemia. In all, 62 patients (4.4%) had left anterior fascicular block (LAFB) on their resting ECG, including 24 who had both LAFB and right bundle branch block.

The exercise ECG stress test showed greatly reduced sensitivity for myocardial ischemia in patients with LAFB on their resting ECG: 39% as compared with 70% in the 1,341 patients without LAFB.

On the other hand, a finding of greater than 1 mm of exercise-induced ST-segment depression in at least two contiguous leads had significantly greater specificity as an indicator of inducible myocardial ischemia when it occurred in the setting of LAFB: 96% as compared with 79% in controls, added Dr. Mousa of New York Hospital Queens in Flushing.

The presence or absence of right bundle branch block in patients with LAFB on their resting ECG did not affect the diagnostic accuracy of their ECG exercise stress test.

DENVER – The majority of nuclear cardiology labs are not utilizing the American College of Cardiology appropriate use criteria for myocardial perfusion imaging, according to the preliminary results of an American Society of Nuclear Cardiology membership survey.

The revelation that only 48% of nuclear cardiology imaging labs employ the ACC appropriate use criteria is disturbing. It comes at a time when nuclear cardiologists are already drawing heat from payers, clinicians, patients, and Congress for perceived overutilization of testing and a casual attitude toward patient exposure to radiation.

The ACC's appropriate use criteria (AUC) program is a high-profile quality improvement initiative. The myocardial perfusion imaging AUC were developed jointly by the ACC, ASNC, and other key specialty societies. Myocardial perfusion imaging (MPI) was the first topic selected for the program, which has since gone on to develop AUC for other common cardiovascular tests and procedures. MPI was selected to go first because of concerns raised by the explosive growth and substantial regional variation in the procedures. The initial version of the MPI AUC was published in 2005, with an updated rendition appearing 2 years ago (J. Am. Coll. Cardiol. 2009;53:2201-9).

ASNC President Leslee J. Shaw, Ph.D., presented the preliminary membership survey results during her presidential address. She also took that occasion to unveil an ambitious new multifaceted ASNC campaign called “Excellence in Imaging.” The program is designed to improve the practice of nuclear cardiology through education and advocacy, and by fostering high-quality research that demonstrates nuclear imaging's clinical value. ASNC members who take the Excellence in Imaging pledge commit themselves to following the AUC.

“By taking a proactive stance on defining quality in nuclear cardiology and demonstrating our members' commitment to these defined quality measures, ASNC will lead the discussion about appropriate use and set the standards by which our patients receive optimal care,” promised Dr. Shaw, professor of medicine at Emory University, Atlanta.

“What the survey results say to me is that we need to do a better job of providing you with tools where you can see the value in improving your process of care, and how the AUC can be utilized to actually identify appropriate patient referral patterns and track your success. This is increasingly going to be a performance metric. Your rating for appropriate test candidates is going to be used as a quality metric,” she explained.

The educational portion of the Excellence in Imaging campaign will include continuing medical education that is designed to raise the quality of imaging by ASNC members, and webinars for referring physicians aimed at fostering appropriate referral patterns. Clinical decision support tools are being developed for smart phones to assist referring physicians in selecting the optimal test for a given patient, rather than leaving the testing decision to be made downstream when the patient arrives at the nuclear cardiology clinic. There will also be public education efforts to dispel widespread misconceptions about radiation safety.

Dr. Manuel D. Cerqueira later observed that shifting the timing of appropriate test decision making to the point when testing is ordered by referring physicians is “easy to say, hard to do.”

No matter how many conversations he has with emergency department physicians at outlying hospitals about not sending him low-risk, inappropriate candidates for imaging procedures involving ionizing radiation exposure when there are better nonradioactive tests available, they continue to do so.

“They're worried about liability, they're worried about their 1-year contract that gets reviewed by the hospital, and they're worried about the pressure the hospital puts on them to do more procedures that are lucrative for the hospital,” said Dr. Cerqueira, professor of radiology and medicine at the Cleveland Clinic Foundation.

In a separate presentation, Dr. Robert C. Hendel, who chaired the writing group for the updated MPI AUC, said a dozen studies presented in the past 5 years show that 10%-15% of all MPIs are inappropriate, as defined by the AUC.

“Basically, if it's an inappropriate indication, by definition the risks exceed the benefits. The best radiation safety we can do is not to perform the test – not to expose the patient – when it's not necessary,” explained Dr. Hendel, professor of medicine and radiology at the University of Miami.

He led a six-center study called SPECT-MPI involving roughly 6,000 consecutive patients who underwent single photon emission CT. Overall, inappropriate use of the procedure occurred in 14.4% of patients, with rates ranging from 4% to 22% among the practices.

The SPECT-MPI study identified the major problem areas for inappropriate utilization. Topping the list was the use of MPI to detect CAD in asymptomatic patients at low risk for coronary heart disease; this accounted for 45% of all inappropriate tests and 6% of total testing.

The five most common inappropriate-use indications accounted for 92% of all inappropriate tests. (See graphic.) If all testing done for these five inappropriate reasons were to be eliminated, total imaging volume would be reduced by 12.4% (J. Am. Coll. Cardiol. 2010;55:156-62).

“Imaging in Focus” is an ACC-sponsored national quality improvement initiative aimed at helping cardiovascular physicians to reduce inappropriate imaging in a collaborative, nonconfrontational way through the use of webinars, blogs, and other tools. It's designed as a learning community whose stated goal is to achieve a 50% reduction in inappropriate imaging in 3 years. Dr. Hendel announced that the program has already resoundingly surpassed that target. In its first year of operation, imaging centers participating in Imaging in Focus reduced their inappropriate imaging by 50% from a baseline rate of 10%.

None of the speakers has relevant financial interests.

'Your rating for appropriate test candidates is going to be used as a quality metric.'

Source DR. SHAW

Source Elsevier Global Medical News

DENVER – The majority of nuclear cardiology labs are not utilizing the American College of Cardiology appropriate use criteria for myocardial perfusion imaging, according to the preliminary results of an American Society of Nuclear Cardiology membership survey.

The revelation that only 48% of nuclear cardiology imaging labs employ the ACC appropriate use criteria is disturbing. It comes at a time when nuclear cardiologists are already drawing heat from payers, clinicians, patients, and Congress for perceived overutilization of testing and a casual attitude toward patient exposure to radiation.

The ACC's appropriate use criteria (AUC) program is a high-profile quality improvement initiative. The myocardial perfusion imaging AUC were developed jointly by the ACC, ASNC, and other key specialty societies. Myocardial perfusion imaging (MPI) was the first topic selected for the program, which has since gone on to develop AUC for other common cardiovascular tests and procedures. MPI was selected to go first because of concerns raised by the explosive growth and substantial regional variation in the procedures. The initial version of the MPI AUC was published in 2005, with an updated rendition appearing 2 years ago (J. Am. Coll. Cardiol. 2009;53:2201-9).

ASNC President Leslee J. Shaw, Ph.D., presented the preliminary membership survey results during her presidential address. She also took that occasion to unveil an ambitious new multifaceted ASNC campaign called “Excellence in Imaging.” The program is designed to improve the practice of nuclear cardiology through education and advocacy, and by fostering high-quality research that demonstrates nuclear imaging's clinical value. ASNC members who take the Excellence in Imaging pledge commit themselves to following the AUC.

“By taking a proactive stance on defining quality in nuclear cardiology and demonstrating our members' commitment to these defined quality measures, ASNC will lead the discussion about appropriate use and set the standards by which our patients receive optimal care,” promised Dr. Shaw, professor of medicine at Emory University, Atlanta.

“What the survey results say to me is that we need to do a better job of providing you with tools where you can see the value in improving your process of care, and how the AUC can be utilized to actually identify appropriate patient referral patterns and track your success. This is increasingly going to be a performance metric. Your rating for appropriate test candidates is going to be used as a quality metric,” she explained.

The educational portion of the Excellence in Imaging campaign will include continuing medical education that is designed to raise the quality of imaging by ASNC members, and webinars for referring physicians aimed at fostering appropriate referral patterns. Clinical decision support tools are being developed for smart phones to assist referring physicians in selecting the optimal test for a given patient, rather than leaving the testing decision to be made downstream when the patient arrives at the nuclear cardiology clinic. There will also be public education efforts to dispel widespread misconceptions about radiation safety.

Dr. Manuel D. Cerqueira later observed that shifting the timing of appropriate test decision making to the point when testing is ordered by referring physicians is “easy to say, hard to do.”

No matter how many conversations he has with emergency department physicians at outlying hospitals about not sending him low-risk, inappropriate candidates for imaging procedures involving ionizing radiation exposure when there are better nonradioactive tests available, they continue to do so.

“They're worried about liability, they're worried about their 1-year contract that gets reviewed by the hospital, and they're worried about the pressure the hospital puts on them to do more procedures that are lucrative for the hospital,” said Dr. Cerqueira, professor of radiology and medicine at the Cleveland Clinic Foundation.

In a separate presentation, Dr. Robert C. Hendel, who chaired the writing group for the updated MPI AUC, said a dozen studies presented in the past 5 years show that 10%-15% of all MPIs are inappropriate, as defined by the AUC.

“Basically, if it's an inappropriate indication, by definition the risks exceed the benefits. The best radiation safety we can do is not to perform the test – not to expose the patient – when it's not necessary,” explained Dr. Hendel, professor of medicine and radiology at the University of Miami.

He led a six-center study called SPECT-MPI involving roughly 6,000 consecutive patients who underwent single photon emission CT. Overall, inappropriate use of the procedure occurred in 14.4% of patients, with rates ranging from 4% to 22% among the practices.

The SPECT-MPI study identified the major problem areas for inappropriate utilization. Topping the list was the use of MPI to detect CAD in asymptomatic patients at low risk for coronary heart disease; this accounted for 45% of all inappropriate tests and 6% of total testing.

The five most common inappropriate-use indications accounted for 92% of all inappropriate tests. (See graphic.) If all testing done for these five inappropriate reasons were to be eliminated, total imaging volume would be reduced by 12.4% (J. Am. Coll. Cardiol. 2010;55:156-62).

“Imaging in Focus” is an ACC-sponsored national quality improvement initiative aimed at helping cardiovascular physicians to reduce inappropriate imaging in a collaborative, nonconfrontational way through the use of webinars, blogs, and other tools. It's designed as a learning community whose stated goal is to achieve a 50% reduction in inappropriate imaging in 3 years. Dr. Hendel announced that the program has already resoundingly surpassed that target. In its first year of operation, imaging centers participating in Imaging in Focus reduced their inappropriate imaging by 50% from a baseline rate of 10%.

None of the speakers has relevant financial interests.

'Your rating for appropriate test candidates is going to be used as a quality metric.'

Source DR. SHAW

Source Elsevier Global Medical News

DENVER – The majority of nuclear cardiology labs are not utilizing the American College of Cardiology appropriate use criteria for myocardial perfusion imaging, according to the preliminary results of an American Society of Nuclear Cardiology membership survey.

The revelation that only 48% of nuclear cardiology imaging labs employ the ACC appropriate use criteria is disturbing. It comes at a time when nuclear cardiologists are already drawing heat from payers, clinicians, patients, and Congress for perceived overutilization of testing and a casual attitude toward patient exposure to radiation.

The ACC's appropriate use criteria (AUC) program is a high-profile quality improvement initiative. The myocardial perfusion imaging AUC were developed jointly by the ACC, ASNC, and other key specialty societies. Myocardial perfusion imaging (MPI) was the first topic selected for the program, which has since gone on to develop AUC for other common cardiovascular tests and procedures. MPI was selected to go first because of concerns raised by the explosive growth and substantial regional variation in the procedures. The initial version of the MPI AUC was published in 2005, with an updated rendition appearing 2 years ago (J. Am. Coll. Cardiol. 2009;53:2201-9).

ASNC President Leslee J. Shaw, Ph.D., presented the preliminary membership survey results during her presidential address. She also took that occasion to unveil an ambitious new multifaceted ASNC campaign called “Excellence in Imaging.” The program is designed to improve the practice of nuclear cardiology through education and advocacy, and by fostering high-quality research that demonstrates nuclear imaging's clinical value. ASNC members who take the Excellence in Imaging pledge commit themselves to following the AUC.

“By taking a proactive stance on defining quality in nuclear cardiology and demonstrating our members' commitment to these defined quality measures, ASNC will lead the discussion about appropriate use and set the standards by which our patients receive optimal care,” promised Dr. Shaw, professor of medicine at Emory University, Atlanta.

“What the survey results say to me is that we need to do a better job of providing you with tools where you can see the value in improving your process of care, and how the AUC can be utilized to actually identify appropriate patient referral patterns and track your success. This is increasingly going to be a performance metric. Your rating for appropriate test candidates is going to be used as a quality metric,” she explained.

The educational portion of the Excellence in Imaging campaign will include continuing medical education that is designed to raise the quality of imaging by ASNC members, and webinars for referring physicians aimed at fostering appropriate referral patterns. Clinical decision support tools are being developed for smart phones to assist referring physicians in selecting the optimal test for a given patient, rather than leaving the testing decision to be made downstream when the patient arrives at the nuclear cardiology clinic. There will also be public education efforts to dispel widespread misconceptions about radiation safety.

Dr. Manuel D. Cerqueira later observed that shifting the timing of appropriate test decision making to the point when testing is ordered by referring physicians is “easy to say, hard to do.”

No matter how many conversations he has with emergency department physicians at outlying hospitals about not sending him low-risk, inappropriate candidates for imaging procedures involving ionizing radiation exposure when there are better nonradioactive tests available, they continue to do so.

“They're worried about liability, they're worried about their 1-year contract that gets reviewed by the hospital, and they're worried about the pressure the hospital puts on them to do more procedures that are lucrative for the hospital,” said Dr. Cerqueira, professor of radiology and medicine at the Cleveland Clinic Foundation.

In a separate presentation, Dr. Robert C. Hendel, who chaired the writing group for the updated MPI AUC, said a dozen studies presented in the past 5 years show that 10%-15% of all MPIs are inappropriate, as defined by the AUC.

“Basically, if it's an inappropriate indication, by definition the risks exceed the benefits. The best radiation safety we can do is not to perform the test – not to expose the patient – when it's not necessary,” explained Dr. Hendel, professor of medicine and radiology at the University of Miami.

He led a six-center study called SPECT-MPI involving roughly 6,000 consecutive patients who underwent single photon emission CT. Overall, inappropriate use of the procedure occurred in 14.4% of patients, with rates ranging from 4% to 22% among the practices.

The SPECT-MPI study identified the major problem areas for inappropriate utilization. Topping the list was the use of MPI to detect CAD in asymptomatic patients at low risk for coronary heart disease; this accounted for 45% of all inappropriate tests and 6% of total testing.

The five most common inappropriate-use indications accounted for 92% of all inappropriate tests. (See graphic.) If all testing done for these five inappropriate reasons were to be eliminated, total imaging volume would be reduced by 12.4% (J. Am. Coll. Cardiol. 2010;55:156-62).

“Imaging in Focus” is an ACC-sponsored national quality improvement initiative aimed at helping cardiovascular physicians to reduce inappropriate imaging in a collaborative, nonconfrontational way through the use of webinars, blogs, and other tools. It's designed as a learning community whose stated goal is to achieve a 50% reduction in inappropriate imaging in 3 years. Dr. Hendel announced that the program has already resoundingly surpassed that target. In its first year of operation, imaging centers participating in Imaging in Focus reduced their inappropriate imaging by 50% from a baseline rate of 10%.

None of the speakers has relevant financial interests.

'Your rating for appropriate test candidates is going to be used as a quality metric.'

Source DR. SHAW

Source Elsevier Global Medical News

SAN DIEGO – Physicians overall are doing a less than stellar job of recognizing glucocorticoid-induced osteoporosis and prescribing bone-protective medications for affected or high-risk patients.

But some specialties are doing significantly better than others.

"While many rheumatologists and endocrinologists are doing a pretty good job, we know that collectively, internationally, this still continues to be a major therapeutic dilemma, and steroids still constitute the most common form of drug-induced osteoporosis," Dr. Kenneth G. Saag declared at the annual meeting of the American Society for Bone and Mineral Research.

He cited a recent as-yet-published study led by University of Alabama epidemiologist Ryan C. Outman, who, together with his coinvestigators, analyzed 106,310 patients in the Medco Pharmacy database who were at high risk for glucocorticoid-induced osteoporosis (GIOP) by virtue of having received more than 90 days of systemic corticosteroid therapy during the study years of 2004-2007.

The primary study outcome was prescription of any form of anti-GIOP medication within 12 months after patients reached the 90-day mark of steroid therapy. The 12-month mark is the point on the therapeutic time line when, according to American College of Rheumatology guidelines, physicians are supposed to initiate bone-protective therapy.

The steroids were prescribed by a total of 53,766 physicians. During the 12-month window, the physicians ordered bone mineral density tests in just 4.6% of the patients, and 23.5% of patients received a prescription for an anti- GIOP medication, according to Dr. Saag, professor of medicine and epidemiology at the University of Alabama, Birmingham.

The results varied by physician specialty. In a multivariate analysis adjusted for patient age, gender, and other potential confounders, endocrinologists were 61% more likely to prescribe anti-GIOP medication for patients having more than 90 days of exposure to systemic steroids than were internists, who served as the reference standard. Rheumatologists were 59% more likely than internists to prescribe therapy.

Nephrologists, pulmonologists, and gastroenterologists were 37%, 34%, and 15%, respectively, more likely to have prescribed bone-protective medications for their at-risk patients than were internists. Dermatologists and physicians in all other specialties who prescribed steroids for longer than 90 days were, collectively, 22% less likely to introduce anti-GIOP therapy than were internists.

Rates of prescription of anti-GIOP medications were particularly low in men of all ages and in premenopausal women. During the 12 months after more than 90 days of exposure to systemic steroids, 36.8% of affected women aged 50 years or older were prescribed bone-protective medication, compared with 11.4% of affected women under age 50 years and 14.7% of men of any age, said Dr. Saag, who was not involved in the study.

"We’ve got a lot of work to do in terms of initiating therapy, but adherence is a big problem, too. Less than half of patients who start on any bone-protective drug are still taking it a year later," he said.

Dr. Saag disclosed that he has received research grants from and serves as a paid consultant to Amgen, Eli Lilly, Merck, and Novartis.

SAN DIEGO – Physicians overall are doing a less than stellar job of recognizing glucocorticoid-induced osteoporosis and prescribing bone-protective medications for affected or high-risk patients.

But some specialties are doing significantly better than others.

"While many rheumatologists and endocrinologists are doing a pretty good job, we know that collectively, internationally, this still continues to be a major therapeutic dilemma, and steroids still constitute the most common form of drug-induced osteoporosis," Dr. Kenneth G. Saag declared at the annual meeting of the American Society for Bone and Mineral Research.

He cited a recent as-yet-published study led by University of Alabama epidemiologist Ryan C. Outman, who, together with his coinvestigators, analyzed 106,310 patients in the Medco Pharmacy database who were at high risk for glucocorticoid-induced osteoporosis (GIOP) by virtue of having received more than 90 days of systemic corticosteroid therapy during the study years of 2004-2007.

The primary study outcome was prescription of any form of anti-GIOP medication within 12 months after patients reached the 90-day mark of steroid therapy. The 12-month mark is the point on the therapeutic time line when, according to American College of Rheumatology guidelines, physicians are supposed to initiate bone-protective therapy.

The steroids were prescribed by a total of 53,766 physicians. During the 12-month window, the physicians ordered bone mineral density tests in just 4.6% of the patients, and 23.5% of patients received a prescription for an anti- GIOP medication, according to Dr. Saag, professor of medicine and epidemiology at the University of Alabama, Birmingham.

The results varied by physician specialty. In a multivariate analysis adjusted for patient age, gender, and other potential confounders, endocrinologists were 61% more likely to prescribe anti-GIOP medication for patients having more than 90 days of exposure to systemic steroids than were internists, who served as the reference standard. Rheumatologists were 59% more likely than internists to prescribe therapy.

Nephrologists, pulmonologists, and gastroenterologists were 37%, 34%, and 15%, respectively, more likely to have prescribed bone-protective medications for their at-risk patients than were internists. Dermatologists and physicians in all other specialties who prescribed steroids for longer than 90 days were, collectively, 22% less likely to introduce anti-GIOP therapy than were internists.

Rates of prescription of anti-GIOP medications were particularly low in men of all ages and in premenopausal women. During the 12 months after more than 90 days of exposure to systemic steroids, 36.8% of affected women aged 50 years or older were prescribed bone-protective medication, compared with 11.4% of affected women under age 50 years and 14.7% of men of any age, said Dr. Saag, who was not involved in the study.

"We’ve got a lot of work to do in terms of initiating therapy, but adherence is a big problem, too. Less than half of patients who start on any bone-protective drug are still taking it a year later," he said.

Dr. Saag disclosed that he has received research grants from and serves as a paid consultant to Amgen, Eli Lilly, Merck, and Novartis.

SAN DIEGO – Physicians overall are doing a less than stellar job of recognizing glucocorticoid-induced osteoporosis and prescribing bone-protective medications for affected or high-risk patients.

But some specialties are doing significantly better than others.

"While many rheumatologists and endocrinologists are doing a pretty good job, we know that collectively, internationally, this still continues to be a major therapeutic dilemma, and steroids still constitute the most common form of drug-induced osteoporosis," Dr. Kenneth G. Saag declared at the annual meeting of the American Society for Bone and Mineral Research.

He cited a recent as-yet-published study led by University of Alabama epidemiologist Ryan C. Outman, who, together with his coinvestigators, analyzed 106,310 patients in the Medco Pharmacy database who were at high risk for glucocorticoid-induced osteoporosis (GIOP) by virtue of having received more than 90 days of systemic corticosteroid therapy during the study years of 2004-2007.

The primary study outcome was prescription of any form of anti-GIOP medication within 12 months after patients reached the 90-day mark of steroid therapy. The 12-month mark is the point on the therapeutic time line when, according to American College of Rheumatology guidelines, physicians are supposed to initiate bone-protective therapy.

The steroids were prescribed by a total of 53,766 physicians. During the 12-month window, the physicians ordered bone mineral density tests in just 4.6% of the patients, and 23.5% of patients received a prescription for an anti- GIOP medication, according to Dr. Saag, professor of medicine and epidemiology at the University of Alabama, Birmingham.

The results varied by physician specialty. In a multivariate analysis adjusted for patient age, gender, and other potential confounders, endocrinologists were 61% more likely to prescribe anti-GIOP medication for patients having more than 90 days of exposure to systemic steroids than were internists, who served as the reference standard. Rheumatologists were 59% more likely than internists to prescribe therapy.

Nephrologists, pulmonologists, and gastroenterologists were 37%, 34%, and 15%, respectively, more likely to have prescribed bone-protective medications for their at-risk patients than were internists. Dermatologists and physicians in all other specialties who prescribed steroids for longer than 90 days were, collectively, 22% less likely to introduce anti-GIOP therapy than were internists.

Rates of prescription of anti-GIOP medications were particularly low in men of all ages and in premenopausal women. During the 12 months after more than 90 days of exposure to systemic steroids, 36.8% of affected women aged 50 years or older were prescribed bone-protective medication, compared with 11.4% of affected women under age 50 years and 14.7% of men of any age, said Dr. Saag, who was not involved in the study.

"We’ve got a lot of work to do in terms of initiating therapy, but adherence is a big problem, too. Less than half of patients who start on any bone-protective drug are still taking it a year later," he said.

Dr. Saag disclosed that he has received research grants from and serves as a paid consultant to Amgen, Eli Lilly, Merck, and Novartis.

SAN DIEGO – Teriparatide has received a boost in status as a preferentially effective treatment for glucocorticoid-induced osteoporosis in the form of a second, confirmatory, randomized double-blind trial demonstrating the anabolic agent achieves substantially greater increases in bone mineral density compared to a bisphosphonate.

One of these studies also included fracture rates as a preplanned secondary endpoint; the trial demonstrated a significant reduction in vertebral fractures with teriparatide (Forteo) as compared to alendronate (Fosamax).

These positive study findings are bolstered by a biologically plausible mechanism of benefit, Dr. Kenneth G. Saag observed at the annual meeting of the American Society for Bone and Mineral Research.

"Based upon the pathogenesis of glucocorticoid-induced osteoporosis [(GIOP)], we think that an anabolic agent makes some sense. It may be beneficial to stimulate osteoblasts to promote new bone formation," said Dr. Saag, professor of medicine and epidemiology at the University of Alabama at Birmingham.

Steroids are known to have apoptosis-mediated deleterious effects on both osteocytes and osteoblasts that lead to decline in bone function and an abrupt increase in fracture risk independent of bone mineral density (BMD). Osteoclasts are also unfavorably impacted due to crosstalk and the indirect effects of sex steroids, insulin-like growth factor, and a modest effect of secondary hyperparathyroidism mediated through altered calcium absorption. In addition, higher-dose steroids have adverse effects upon muscle that can independently lead to a higher fracture rate, the rheumatologist explained.

The FDA has approved alendronate, zoledronic acid (Reclast), and risedronate (Actonel) for treatment GIOP. More recently, raloxifene (Evista) has joined the ranks of agents shown to increase BMD in patients on long-term steroids; this came in the form of a double-blind, placebo-controlled, 12-month study (Ann. Rheum. Dis. 2011;70:778-84).

Subcutaneous daily teriparatide for up to 2 years also has the approval of the Food and Drug Administration for use in adults at high fracture risk because they are on sustained systemic steroid therapy.

There is no definitive study demonstrating that any of these agents actually prevents fractures in patients with GIOP. Nor is it likely such a study will be undertaken. Such trials require large numbers of patients and lengthy follow-up, and pharmaceutical companies have little incentive to mount such a costly project given that the medications are already approved for use in patients on steroids, Dr. Saag noted.

However, data from a study in which Dr. Saag was lead investigator showed that teriparatide-treated patients had significantly fewer vertebral fractures than those assigned to alendronate. The study was a 36-month randomized, double-blind, clinical trial that assessed fracture rates as a preplanned secondary endpoint. The radiographic and clinical vertebral fracture rates in 169 alendronate-treated patients were 7.7% and 2.4%, respectively, compared to 1.7% and 0% in 173 teriparatide-treated patients (P = .007 and .037). No significant difference in nonvertebral fractures was found between the two treatment arms.

The primary study endpoint was the change in BMD from baseline. Here again teriparatide proved significantly more effective than the bisphosphonate, with a mean 11% increase at the lumbar spine, compared to 5.3% with alendronate. Teriparatide-treated patients also had a 5.2% increase in BMD at the total hip and a 6.3% boost at the femoral neck, compared to 2.7% and 3.4%, respectively, with alendronate (Arthritis Rheum. 2009;60:3346-55).

Confirmation of teriparatide’s superior BMD-building effect came from the EuroGIOPs trial presented by Dr. Claus C. Glüer at the ASBMR meeting.

EuroGIOPS was an 18-month, open-label, phase III clinical trial in which 92 men with GIOP were randomized to teriparatide or risedronate. At 6 months the mean increase in lumbar spine BMD was 5.7% in the teriparatide group, compared with 3.3% in the risedronate arm. At 18 months – the primary study endpoint – the teriparatide group averaged a 16.3% BMD increase over baseline, while the risedronate arm had a 3.8% rise.

Intriguingly, new clinical fractures occurred during 18 months of therapy in 5 patients on risedronate and none on teriparatide, a difference that came within a hair of statistical significance (P = .056).

Bone strength as formally measured in terms of anterior bending, axial compression, and axial torsion was also significantly greater in the teriparatide group, according to Dr. Glüer, who is professor of medical physics at the department of diagnostic radiology, University Hospital Schleswig-Holstein in Kiel, Germany.

The 2010 update of the American College of Rheumatology guidelines for the prevention and treatment of GIOP recommend bisphosphonates but not teriparatide for older adults at high risk of fracture who are taking less than 5 mg/day of prednisone for less than 1 month (Arthritis Care Res. 2010;62:1515-26). The ACR guidelines recommend reserving use of teriparatide for high-risk patients – that is, those with a prevalent fracture or a World Health Organization Fracture Risk Assessment Tool (FRAX) score indicative of a greater than 20% 10-year risk of a major osteoporotic fracture – who are on at least 6 mg/day of prednisone for less than 1 month or on any dose of glucocorticoids for longer than 1 month.

Although Dr. Saag was a coauthor of the ACR guidelines, he disagreed with this particular one in light of his own clinical trial findings as well as evidence that BMD loss and fracture risk increase early on after starting steroids, and at lower doses than previously thought problematic. So he was pleased to see a new commentary on the ACR guidelines published by the Professional Practice Committee of the ASBMR. The review recommends teriparatide or any of the bisphosphonates for high-risk patients, period.

Dr. Saag, who wasn’t involved in the ASBMR review, recommended it as useful reading both for its areas of agreement with the ACR guidelines as well as for raising several patient scenarios in which the ASBMR committee believes the ACR recommendations either don’t apply or might be improved upon.

The ASBMR commentary also lays out a research agenda, identifying key areas for future study. For example, what’s the best management strategy in lupus patients and others who may need to be on systemic steroids for a decade or more, given that teriparatide is only FDA approved for 2 years of daily use and the clinical trials of bisphosphonates for GIOPS were only 1 or 2 years long (J. Bone Miner. Res. 2011;26:1989-96).

Dr. Glüer declared having no financial conflicts regarding the Eli Lilly-funded EuroGIOPs trial. Dr. Saag disclosed that he has received research grants from and serves as a paid consultant to Amgen, Eli Lilly, Merck, and Novartis.

SAN DIEGO – Teriparatide has received a boost in status as a preferentially effective treatment for glucocorticoid-induced osteoporosis in the form of a second, confirmatory, randomized double-blind trial demonstrating the anabolic agent achieves substantially greater increases in bone mineral density compared to a bisphosphonate.

One of these studies also included fracture rates as a preplanned secondary endpoint; the trial demonstrated a significant reduction in vertebral fractures with teriparatide (Forteo) as compared to alendronate (Fosamax).

These positive study findings are bolstered by a biologically plausible mechanism of benefit, Dr. Kenneth G. Saag observed at the annual meeting of the American Society for Bone and Mineral Research.

"Based upon the pathogenesis of glucocorticoid-induced osteoporosis [(GIOP)], we think that an anabolic agent makes some sense. It may be beneficial to stimulate osteoblasts to promote new bone formation," said Dr. Saag, professor of medicine and epidemiology at the University of Alabama at Birmingham.

Steroids are known to have apoptosis-mediated deleterious effects on both osteocytes and osteoblasts that lead to decline in bone function and an abrupt increase in fracture risk independent of bone mineral density (BMD). Osteoclasts are also unfavorably impacted due to crosstalk and the indirect effects of sex steroids, insulin-like growth factor, and a modest effect of secondary hyperparathyroidism mediated through altered calcium absorption. In addition, higher-dose steroids have adverse effects upon muscle that can independently lead to a higher fracture rate, the rheumatologist explained.

The FDA has approved alendronate, zoledronic acid (Reclast), and risedronate (Actonel) for treatment GIOP. More recently, raloxifene (Evista) has joined the ranks of agents shown to increase BMD in patients on long-term steroids; this came in the form of a double-blind, placebo-controlled, 12-month study (Ann. Rheum. Dis. 2011;70:778-84).

Subcutaneous daily teriparatide for up to 2 years also has the approval of the Food and Drug Administration for use in adults at high fracture risk because they are on sustained systemic steroid therapy.

There is no definitive study demonstrating that any of these agents actually prevents fractures in patients with GIOP. Nor is it likely such a study will be undertaken. Such trials require large numbers of patients and lengthy follow-up, and pharmaceutical companies have little incentive to mount such a costly project given that the medications are already approved for use in patients on steroids, Dr. Saag noted.

However, data from a study in which Dr. Saag was lead investigator showed that teriparatide-treated patients had significantly fewer vertebral fractures than those assigned to alendronate. The study was a 36-month randomized, double-blind, clinical trial that assessed fracture rates as a preplanned secondary endpoint. The radiographic and clinical vertebral fracture rates in 169 alendronate-treated patients were 7.7% and 2.4%, respectively, compared to 1.7% and 0% in 173 teriparatide-treated patients (P = .007 and .037). No significant difference in nonvertebral fractures was found between the two treatment arms.

The primary study endpoint was the change in BMD from baseline. Here again teriparatide proved significantly more effective than the bisphosphonate, with a mean 11% increase at the lumbar spine, compared to 5.3% with alendronate. Teriparatide-treated patients also had a 5.2% increase in BMD at the total hip and a 6.3% boost at the femoral neck, compared to 2.7% and 3.4%, respectively, with alendronate (Arthritis Rheum. 2009;60:3346-55).

Confirmation of teriparatide’s superior BMD-building effect came from the EuroGIOPs trial presented by Dr. Claus C. Glüer at the ASBMR meeting.

EuroGIOPS was an 18-month, open-label, phase III clinical trial in which 92 men with GIOP were randomized to teriparatide or risedronate. At 6 months the mean increase in lumbar spine BMD was 5.7% in the teriparatide group, compared with 3.3% in the risedronate arm. At 18 months – the primary study endpoint – the teriparatide group averaged a 16.3% BMD increase over baseline, while the risedronate arm had a 3.8% rise.

Intriguingly, new clinical fractures occurred during 18 months of therapy in 5 patients on risedronate and none on teriparatide, a difference that came within a hair of statistical significance (P = .056).

Bone strength as formally measured in terms of anterior bending, axial compression, and axial torsion was also significantly greater in the teriparatide group, according to Dr. Glüer, who is professor of medical physics at the department of diagnostic radiology, University Hospital Schleswig-Holstein in Kiel, Germany.

The 2010 update of the American College of Rheumatology guidelines for the prevention and treatment of GIOP recommend bisphosphonates but not teriparatide for older adults at high risk of fracture who are taking less than 5 mg/day of prednisone for less than 1 month (Arthritis Care Res. 2010;62:1515-26). The ACR guidelines recommend reserving use of teriparatide for high-risk patients – that is, those with a prevalent fracture or a World Health Organization Fracture Risk Assessment Tool (FRAX) score indicative of a greater than 20% 10-year risk of a major osteoporotic fracture – who are on at least 6 mg/day of prednisone for less than 1 month or on any dose of glucocorticoids for longer than 1 month.

Although Dr. Saag was a coauthor of the ACR guidelines, he disagreed with this particular one in light of his own clinical trial findings as well as evidence that BMD loss and fracture risk increase early on after starting steroids, and at lower doses than previously thought problematic. So he was pleased to see a new commentary on the ACR guidelines published by the Professional Practice Committee of the ASBMR. The review recommends teriparatide or any of the bisphosphonates for high-risk patients, period.

Dr. Saag, who wasn’t involved in the ASBMR review, recommended it as useful reading both for its areas of agreement with the ACR guidelines as well as for raising several patient scenarios in which the ASBMR committee believes the ACR recommendations either don’t apply or might be improved upon.

The ASBMR commentary also lays out a research agenda, identifying key areas for future study. For example, what’s the best management strategy in lupus patients and others who may need to be on systemic steroids for a decade or more, given that teriparatide is only FDA approved for 2 years of daily use and the clinical trials of bisphosphonates for GIOPS were only 1 or 2 years long (J. Bone Miner. Res. 2011;26:1989-96).

Dr. Glüer declared having no financial conflicts regarding the Eli Lilly-funded EuroGIOPs trial. Dr. Saag disclosed that he has received research grants from and serves as a paid consultant to Amgen, Eli Lilly, Merck, and Novartis.

SAN DIEGO – Teriparatide has received a boost in status as a preferentially effective treatment for glucocorticoid-induced osteoporosis in the form of a second, confirmatory, randomized double-blind trial demonstrating the anabolic agent achieves substantially greater increases in bone mineral density compared to a bisphosphonate.

One of these studies also included fracture rates as a preplanned secondary endpoint; the trial demonstrated a significant reduction in vertebral fractures with teriparatide (Forteo) as compared to alendronate (Fosamax).

These positive study findings are bolstered by a biologically plausible mechanism of benefit, Dr. Kenneth G. Saag observed at the annual meeting of the American Society for Bone and Mineral Research.

"Based upon the pathogenesis of glucocorticoid-induced osteoporosis [(GIOP)], we think that an anabolic agent makes some sense. It may be beneficial to stimulate osteoblasts to promote new bone formation," said Dr. Saag, professor of medicine and epidemiology at the University of Alabama at Birmingham.

Steroids are known to have apoptosis-mediated deleterious effects on both osteocytes and osteoblasts that lead to decline in bone function and an abrupt increase in fracture risk independent of bone mineral density (BMD). Osteoclasts are also unfavorably impacted due to crosstalk and the indirect effects of sex steroids, insulin-like growth factor, and a modest effect of secondary hyperparathyroidism mediated through altered calcium absorption. In addition, higher-dose steroids have adverse effects upon muscle that can independently lead to a higher fracture rate, the rheumatologist explained.

The FDA has approved alendronate, zoledronic acid (Reclast), and risedronate (Actonel) for treatment GIOP. More recently, raloxifene (Evista) has joined the ranks of agents shown to increase BMD in patients on long-term steroids; this came in the form of a double-blind, placebo-controlled, 12-month study (Ann. Rheum. Dis. 2011;70:778-84).

Subcutaneous daily teriparatide for up to 2 years also has the approval of the Food and Drug Administration for use in adults at high fracture risk because they are on sustained systemic steroid therapy.

There is no definitive study demonstrating that any of these agents actually prevents fractures in patients with GIOP. Nor is it likely such a study will be undertaken. Such trials require large numbers of patients and lengthy follow-up, and pharmaceutical companies have little incentive to mount such a costly project given that the medications are already approved for use in patients on steroids, Dr. Saag noted.

However, data from a study in which Dr. Saag was lead investigator showed that teriparatide-treated patients had significantly fewer vertebral fractures than those assigned to alendronate. The study was a 36-month randomized, double-blind, clinical trial that assessed fracture rates as a preplanned secondary endpoint. The radiographic and clinical vertebral fracture rates in 169 alendronate-treated patients were 7.7% and 2.4%, respectively, compared to 1.7% and 0% in 173 teriparatide-treated patients (P = .007 and .037). No significant difference in nonvertebral fractures was found between the two treatment arms.

The primary study endpoint was the change in BMD from baseline. Here again teriparatide proved significantly more effective than the bisphosphonate, with a mean 11% increase at the lumbar spine, compared to 5.3% with alendronate. Teriparatide-treated patients also had a 5.2% increase in BMD at the total hip and a 6.3% boost at the femoral neck, compared to 2.7% and 3.4%, respectively, with alendronate (Arthritis Rheum. 2009;60:3346-55).

Confirmation of teriparatide’s superior BMD-building effect came from the EuroGIOPs trial presented by Dr. Claus C. Glüer at the ASBMR meeting.

EuroGIOPS was an 18-month, open-label, phase III clinical trial in which 92 men with GIOP were randomized to teriparatide or risedronate. At 6 months the mean increase in lumbar spine BMD was 5.7% in the teriparatide group, compared with 3.3% in the risedronate arm. At 18 months – the primary study endpoint – the teriparatide group averaged a 16.3% BMD increase over baseline, while the risedronate arm had a 3.8% rise.

Intriguingly, new clinical fractures occurred during 18 months of therapy in 5 patients on risedronate and none on teriparatide, a difference that came within a hair of statistical significance (P = .056).

Bone strength as formally measured in terms of anterior bending, axial compression, and axial torsion was also significantly greater in the teriparatide group, according to Dr. Glüer, who is professor of medical physics at the department of diagnostic radiology, University Hospital Schleswig-Holstein in Kiel, Germany.

The 2010 update of the American College of Rheumatology guidelines for the prevention and treatment of GIOP recommend bisphosphonates but not teriparatide for older adults at high risk of fracture who are taking less than 5 mg/day of prednisone for less than 1 month (Arthritis Care Res. 2010;62:1515-26). The ACR guidelines recommend reserving use of teriparatide for high-risk patients – that is, those with a prevalent fracture or a World Health Organization Fracture Risk Assessment Tool (FRAX) score indicative of a greater than 20% 10-year risk of a major osteoporotic fracture – who are on at least 6 mg/day of prednisone for less than 1 month or on any dose of glucocorticoids for longer than 1 month.

Although Dr. Saag was a coauthor of the ACR guidelines, he disagreed with this particular one in light of his own clinical trial findings as well as evidence that BMD loss and fracture risk increase early on after starting steroids, and at lower doses than previously thought problematic. So he was pleased to see a new commentary on the ACR guidelines published by the Professional Practice Committee of the ASBMR. The review recommends teriparatide or any of the bisphosphonates for high-risk patients, period.

Dr. Saag, who wasn’t involved in the ASBMR review, recommended it as useful reading both for its areas of agreement with the ACR guidelines as well as for raising several patient scenarios in which the ASBMR committee believes the ACR recommendations either don’t apply or might be improved upon.

The ASBMR commentary also lays out a research agenda, identifying key areas for future study. For example, what’s the best management strategy in lupus patients and others who may need to be on systemic steroids for a decade or more, given that teriparatide is only FDA approved for 2 years of daily use and the clinical trials of bisphosphonates for GIOPS were only 1 or 2 years long (J. Bone Miner. Res. 2011;26:1989-96).

Dr. Glüer declared having no financial conflicts regarding the Eli Lilly-funded EuroGIOPs trial. Dr. Saag disclosed that he has received research grants from and serves as a paid consultant to Amgen, Eli Lilly, Merck, and Novartis.

SAN DIEGO – Heart failure constitutes a previously unrecognized independent risk factor for major osteoporotic fractures, according to a Canadian cohort study.

"Patients with heart failure have double the 5-year risk of fracture," compared with those without heart failure. And "patients with heart failure have lower bone mineral density at every skeletal site at the time of their first test," compared with those without heart failure. "Finally, neither differences in bone mass nor shared risk factors [are enough] to explain the increased risk," said Dr. Sumit Majumdar at the annual meeting of the American Society for Bone and Mineral Research.

He presented a population-based cohort study that included all Manitobans older than age 50 years who had their first bone mineral density test in 1998-2009. The study earned him the 2011 ASBMR Most Outstanding Clinical Abstract Award.

Overall, 4% of the nearly 46,000 Manitobans who had an initial bone minteral density (BMD) test during the study years were identified as having recent-onset heart failure (that is, heart failure diagnosed within the previous 2 years). There were 2,703 new fractures in the study population during a median 5 years of follow-up. The recent heart failure group had a 10% incidence of major nontraumatic fractures of the upper extremities, vertebrae, and hip during the 5 years following the first BMD test, compared with a 5% incidence in subjects without heart failure.

The median time to first fracture in the heart failure group was 3.6 years. The curves describing fracture incidence started to diverge soon after the first BMD test and continued to widen throughout the maximum 10 years of follow-up, reported Dr. Majumdar, professor of general internal medicine at the University of Alberta, Edmonton.

Patients with heart failure had more of all the standard risk factors for osteoporosis (except weight) than did subjects without heart failure. They were significantly older (mean age, 74 vs. 66 years) and 21% of them had a prior major osteoporotic fracture, compared with 13% of those without heart failure. Some 12% of heart failure patients had been on systemic corticosteroids for longer than 90 days, compared with 4% of those without heart failure.

Moreover, 40% of heart failure patients had osteoporosis at the time of their first BMD measurement (defined as a T score less than –2.5 at any skeletal site), compared with 29% of individuals without heart failure. T scores were significantly lower in the heart failure group at all measured sites.

"A diagnosis of heart failure portends an increased risk of fracture greater than rheumatoid arthritis or prior fracture."

On the other hand, nearly every medication used in treating heart failure has previously been shown to increase BMD and to reduce fracture risk, with the exception of loop diuretics, which reduce BMD.

In addition, osteoporosis and heart failure are common, chronic conditions that share several etiologic risk factors, including older age, postmenopausal status, diabetes, and smoking, he continued.

The unadjusted risk of a major osteoporotic fracture was increased 2.45-fold in patients with heart failure. But upon adjustment in a multivariate analysis for nearly 30 potential confounders including age, sex, osteoporosis-related factors, medications, comorbidities, and total hip BMD, heart failure remained independently associated with a highly significant 28% increased risk of major osteoporotic fractures.

A disturbing finding of the study was that a mere 14% of heart failure patients who experienced an osteoporotic fracture were then placed on a bisphosphonate or other bone-protective therapy. Bisphosphonates had no association with mortality in the heart failure group.

"For clinicians, I think our study means we need to start understanding that a diagnosis of heart failure portends an increased risk of fracture greater than rheumatoid arthritis or prior fracture, in our data. And we need to learn that patients with heart failure are easily diagnosed and need much more attention to their bone health," Dr. Majumdar observed.

This study also opens up research opportunities for bench scientists, as the Manitoba database contains no information on patients’ aldosterone, parathyroid hormone, or vitamin D levels, or indeed on any other variables that might provide a mechanistic explanation for the link between heart failure and osteoporotic fractures.

"Ours is an example of bedside-to-bench research," he said.

In that vein, one audience member noted that increased adrenergic drive is a hallmark of heart failure. He wondered if heart failure patients on beta-blocker therapy had a lower fracture risk. Dr. Majumdar replied that he and his coinvestigators had had the same thought. However, when they specifically compared the nearly 35% of heart failure patients who were on a beta-blocker vs. those who weren’t, they found that fracture rates in the two groups weren’t significantly different.

Dr. Majumdar declared having no relevant financial interests.

SAN DIEGO – Heart failure constitutes a previously unrecognized independent risk factor for major osteoporotic fractures, according to a Canadian cohort study.

"Patients with heart failure have double the 5-year risk of fracture," compared with those without heart failure. And "patients with heart failure have lower bone mineral density at every skeletal site at the time of their first test," compared with those without heart failure. "Finally, neither differences in bone mass nor shared risk factors [are enough] to explain the increased risk," said Dr. Sumit Majumdar at the annual meeting of the American Society for Bone and Mineral Research.

He presented a population-based cohort study that included all Manitobans older than age 50 years who had their first bone mineral density test in 1998-2009. The study earned him the 2011 ASBMR Most Outstanding Clinical Abstract Award.

Overall, 4% of the nearly 46,000 Manitobans who had an initial bone minteral density (BMD) test during the study years were identified as having recent-onset heart failure (that is, heart failure diagnosed within the previous 2 years). There were 2,703 new fractures in the study population during a median 5 years of follow-up. The recent heart failure group had a 10% incidence of major nontraumatic fractures of the upper extremities, vertebrae, and hip during the 5 years following the first BMD test, compared with a 5% incidence in subjects without heart failure.

The median time to first fracture in the heart failure group was 3.6 years. The curves describing fracture incidence started to diverge soon after the first BMD test and continued to widen throughout the maximum 10 years of follow-up, reported Dr. Majumdar, professor of general internal medicine at the University of Alberta, Edmonton.

Patients with heart failure had more of all the standard risk factors for osteoporosis (except weight) than did subjects without heart failure. They were significantly older (mean age, 74 vs. 66 years) and 21% of them had a prior major osteoporotic fracture, compared with 13% of those without heart failure. Some 12% of heart failure patients had been on systemic corticosteroids for longer than 90 days, compared with 4% of those without heart failure.

Moreover, 40% of heart failure patients had osteoporosis at the time of their first BMD measurement (defined as a T score less than –2.5 at any skeletal site), compared with 29% of individuals without heart failure. T scores were significantly lower in the heart failure group at all measured sites.

"A diagnosis of heart failure portends an increased risk of fracture greater than rheumatoid arthritis or prior fracture."

On the other hand, nearly every medication used in treating heart failure has previously been shown to increase BMD and to reduce fracture risk, with the exception of loop diuretics, which reduce BMD.

In addition, osteoporosis and heart failure are common, chronic conditions that share several etiologic risk factors, including older age, postmenopausal status, diabetes, and smoking, he continued.

The unadjusted risk of a major osteoporotic fracture was increased 2.45-fold in patients with heart failure. But upon adjustment in a multivariate analysis for nearly 30 potential confounders including age, sex, osteoporosis-related factors, medications, comorbidities, and total hip BMD, heart failure remained independently associated with a highly significant 28% increased risk of major osteoporotic fractures.

A disturbing finding of the study was that a mere 14% of heart failure patients who experienced an osteoporotic fracture were then placed on a bisphosphonate or other bone-protective therapy. Bisphosphonates had no association with mortality in the heart failure group.

"For clinicians, I think our study means we need to start understanding that a diagnosis of heart failure portends an increased risk of fracture greater than rheumatoid arthritis or prior fracture, in our data. And we need to learn that patients with heart failure are easily diagnosed and need much more attention to their bone health," Dr. Majumdar observed.

This study also opens up research opportunities for bench scientists, as the Manitoba database contains no information on patients’ aldosterone, parathyroid hormone, or vitamin D levels, or indeed on any other variables that might provide a mechanistic explanation for the link between heart failure and osteoporotic fractures.

"Ours is an example of bedside-to-bench research," he said.

In that vein, one audience member noted that increased adrenergic drive is a hallmark of heart failure. He wondered if heart failure patients on beta-blocker therapy had a lower fracture risk. Dr. Majumdar replied that he and his coinvestigators had had the same thought. However, when they specifically compared the nearly 35% of heart failure patients who were on a beta-blocker vs. those who weren’t, they found that fracture rates in the two groups weren’t significantly different.

Dr. Majumdar declared having no relevant financial interests.

SAN DIEGO – Heart failure constitutes a previously unrecognized independent risk factor for major osteoporotic fractures, according to a Canadian cohort study.

"Patients with heart failure have double the 5-year risk of fracture," compared with those without heart failure. And "patients with heart failure have lower bone mineral density at every skeletal site at the time of their first test," compared with those without heart failure. "Finally, neither differences in bone mass nor shared risk factors [are enough] to explain the increased risk," said Dr. Sumit Majumdar at the annual meeting of the American Society for Bone and Mineral Research.

He presented a population-based cohort study that included all Manitobans older than age 50 years who had their first bone mineral density test in 1998-2009. The study earned him the 2011 ASBMR Most Outstanding Clinical Abstract Award.

Overall, 4% of the nearly 46,000 Manitobans who had an initial bone minteral density (BMD) test during the study years were identified as having recent-onset heart failure (that is, heart failure diagnosed within the previous 2 years). There were 2,703 new fractures in the study population during a median 5 years of follow-up. The recent heart failure group had a 10% incidence of major nontraumatic fractures of the upper extremities, vertebrae, and hip during the 5 years following the first BMD test, compared with a 5% incidence in subjects without heart failure.

The median time to first fracture in the heart failure group was 3.6 years. The curves describing fracture incidence started to diverge soon after the first BMD test and continued to widen throughout the maximum 10 years of follow-up, reported Dr. Majumdar, professor of general internal medicine at the University of Alberta, Edmonton.

Patients with heart failure had more of all the standard risk factors for osteoporosis (except weight) than did subjects without heart failure. They were significantly older (mean age, 74 vs. 66 years) and 21% of them had a prior major osteoporotic fracture, compared with 13% of those without heart failure. Some 12% of heart failure patients had been on systemic corticosteroids for longer than 90 days, compared with 4% of those without heart failure.

Moreover, 40% of heart failure patients had osteoporosis at the time of their first BMD measurement (defined as a T score less than –2.5 at any skeletal site), compared with 29% of individuals without heart failure. T scores were significantly lower in the heart failure group at all measured sites.

"A diagnosis of heart failure portends an increased risk of fracture greater than rheumatoid arthritis or prior fracture."

On the other hand, nearly every medication used in treating heart failure has previously been shown to increase BMD and to reduce fracture risk, with the exception of loop diuretics, which reduce BMD.

In addition, osteoporosis and heart failure are common, chronic conditions that share several etiologic risk factors, including older age, postmenopausal status, diabetes, and smoking, he continued.

The unadjusted risk of a major osteoporotic fracture was increased 2.45-fold in patients with heart failure. But upon adjustment in a multivariate analysis for nearly 30 potential confounders including age, sex, osteoporosis-related factors, medications, comorbidities, and total hip BMD, heart failure remained independently associated with a highly significant 28% increased risk of major osteoporotic fractures.

A disturbing finding of the study was that a mere 14% of heart failure patients who experienced an osteoporotic fracture were then placed on a bisphosphonate or other bone-protective therapy. Bisphosphonates had no association with mortality in the heart failure group.

"For clinicians, I think our study means we need to start understanding that a diagnosis of heart failure portends an increased risk of fracture greater than rheumatoid arthritis or prior fracture, in our data. And we need to learn that patients with heart failure are easily diagnosed and need much more attention to their bone health," Dr. Majumdar observed.

This study also opens up research opportunities for bench scientists, as the Manitoba database contains no information on patients’ aldosterone, parathyroid hormone, or vitamin D levels, or indeed on any other variables that might provide a mechanistic explanation for the link between heart failure and osteoporotic fractures.

"Ours is an example of bedside-to-bench research," he said.

In that vein, one audience member noted that increased adrenergic drive is a hallmark of heart failure. He wondered if heart failure patients on beta-blocker therapy had a lower fracture risk. Dr. Majumdar replied that he and his coinvestigators had had the same thought. However, when they specifically compared the nearly 35% of heart failure patients who were on a beta-blocker vs. those who weren’t, they found that fracture rates in the two groups weren’t significantly different.

Dr. Majumdar declared having no relevant financial interests.

SAN DIEGO – The risk of hip fracture nearly doubles during the week following a new prescription for a loop diuretic.

In contrast, there is no spike in the risk of hip fracture in the 7 days following a new prescription for other classes of diuretics or for ACE inhibitors, according to an analysis of the massive The Health Improvement Network (THIN) database involving more than 400 U.K. primary care practices.

The most likely explanation for the short-term jump in risk of hip fracture may be related to the prominent urinary symptoms that often accompany a new prescription for loop diuretics. The resultant rush to the bathroom could lead to an increased rate of falls during that initial adjustment period, Dr. Sarah D. Berry speculated at the annual meeting of the American Society for Bone and Mineral Research.

She reported on 28,703 subjects who experienced an incident hip fracture and more than 2 million others who did not during 15.1 million person-years of follow-up recorded in the THIN primary care database. In a nested, case-crossover study, she and her coworkers compared the occurrence of new diuretic prescriptions in the 7 days prior to the hip fracture to the occurrence of new diuretic prescriptions during the control period 31-37 days before the fracture.

The adjusted odds ratio of an incident hip fracture was significantly increased by 80% during the 7 days following a new prescription for a loop diuretic. That being said, it needs to be emphasized that the absolute risk during this week-long window of increased vulnerability remained low: 2.9 hip fractures per 100,000 new loop diuretic prescriptions, according to Dr. Berry of the Hebrew SeniorLife Institute for Aging Research and Beth Israel Deaconess Medical Center, Boston.

Counseling vulnerable older adults and their caregivers about the need for increased awareness and careful ambulation to the bathroom during the 7 days after going on a loop diuretic might help reduce hip fractures, she added.

Dr. Berry declared having no financial conflicts regarding the study, which was supported by the U.S. National Institutes of Health and Hebrew SeniorLife.

SAN DIEGO – The risk of hip fracture nearly doubles during the week following a new prescription for a loop diuretic.

In contrast, there is no spike in the risk of hip fracture in the 7 days following a new prescription for other classes of diuretics or for ACE inhibitors, according to an analysis of the massive The Health Improvement Network (THIN) database involving more than 400 U.K. primary care practices.

The most likely explanation for the short-term jump in risk of hip fracture may be related to the prominent urinary symptoms that often accompany a new prescription for loop diuretics. The resultant rush to the bathroom could lead to an increased rate of falls during that initial adjustment period, Dr. Sarah D. Berry speculated at the annual meeting of the American Society for Bone and Mineral Research.

She reported on 28,703 subjects who experienced an incident hip fracture and more than 2 million others who did not during 15.1 million person-years of follow-up recorded in the THIN primary care database. In a nested, case-crossover study, she and her coworkers compared the occurrence of new diuretic prescriptions in the 7 days prior to the hip fracture to the occurrence of new diuretic prescriptions during the control period 31-37 days before the fracture.

The adjusted odds ratio of an incident hip fracture was significantly increased by 80% during the 7 days following a new prescription for a loop diuretic. That being said, it needs to be emphasized that the absolute risk during this week-long window of increased vulnerability remained low: 2.9 hip fractures per 100,000 new loop diuretic prescriptions, according to Dr. Berry of the Hebrew SeniorLife Institute for Aging Research and Beth Israel Deaconess Medical Center, Boston.

Counseling vulnerable older adults and their caregivers about the need for increased awareness and careful ambulation to the bathroom during the 7 days after going on a loop diuretic might help reduce hip fractures, she added.

Dr. Berry declared having no financial conflicts regarding the study, which was supported by the U.S. National Institutes of Health and Hebrew SeniorLife.

SAN DIEGO – The risk of hip fracture nearly doubles during the week following a new prescription for a loop diuretic.

In contrast, there is no spike in the risk of hip fracture in the 7 days following a new prescription for other classes of diuretics or for ACE inhibitors, according to an analysis of the massive The Health Improvement Network (THIN) database involving more than 400 U.K. primary care practices.

The most likely explanation for the short-term jump in risk of hip fracture may be related to the prominent urinary symptoms that often accompany a new prescription for loop diuretics. The resultant rush to the bathroom could lead to an increased rate of falls during that initial adjustment period, Dr. Sarah D. Berry speculated at the annual meeting of the American Society for Bone and Mineral Research.

She reported on 28,703 subjects who experienced an incident hip fracture and more than 2 million others who did not during 15.1 million person-years of follow-up recorded in the THIN primary care database. In a nested, case-crossover study, she and her coworkers compared the occurrence of new diuretic prescriptions in the 7 days prior to the hip fracture to the occurrence of new diuretic prescriptions during the control period 31-37 days before the fracture.

The adjusted odds ratio of an incident hip fracture was significantly increased by 80% during the 7 days following a new prescription for a loop diuretic. That being said, it needs to be emphasized that the absolute risk during this week-long window of increased vulnerability remained low: 2.9 hip fractures per 100,000 new loop diuretic prescriptions, according to Dr. Berry of the Hebrew SeniorLife Institute for Aging Research and Beth Israel Deaconess Medical Center, Boston.

Counseling vulnerable older adults and their caregivers about the need for increased awareness and careful ambulation to the bathroom during the 7 days after going on a loop diuretic might help reduce hip fractures, she added.

Dr. Berry declared having no financial conflicts regarding the study, which was supported by the U.S. National Institutes of Health and Hebrew SeniorLife.

DENVER – The majority of nuclear cardiology labs are not utilizing the American College of Cardiology appropriate use criteria for myocardial perfusion imaging, according to the preliminary results of an American Society of Nuclear Cardiology membership survey.

The revelation that only 48% of nuclear cardiology imaging labs employ the ACC appropriate use criteria is disturbing. It comes at a time when nuclear cardiologists are already drawing heat from payers, clinicians, patients, and Congress for perceived overutilization of testing and a casual attitude toward patient exposure to radiation.

The ACC’s appropriate use criteria (AUC) program is a high-profile quality improvement initiative. The myocardial perfusion imaging AUC were developed jointly by the ACC, ASNC, and other key specialty societies. Myocardial perfusion imaging (MPI) was the first topic selected for the program, which has since gone on to develop AUC for other common cardiovascular tests and procedures. MPI was selected to go first because of concerns raised by the explosive growth and substantial regional variation in the procedures. The initial version of the MPI AUC was published in 2005, with an updated rendition appearing 2 years ago (J. Am. Coll. Cardiol. 2009;53:2201-9).

ASNC President Leslee J. Shaw, Ph.D., presented the preliminary membership survey results during her presidential address at the annual meeting of the American Society of Nuclear Cardiology. She also took that occasion to unveil an ambitious new multifaceted ASNC campaign called "Excellence in Imaging." The program is designed to improve the practice of nuclear cardiology through education and advocacy, and by fostering high-quality research that demonstrates nuclear imaging’s clinical value. ASNC members who take the Excellence in Imaging pledge commit themselves to following the AUC.

"By taking a proactive stance on defining quality in nuclear cardiology and demonstrating our members’ commitment to these defined quality measures, ASNC will lead the discussion about appropriate use and set the standards by which our patients receive optimal care," promised Dr. Shaw, professor of medicine at Emory University, Atlanta.

"What the survey results say to me is that we need to do a better job of providing you with tools where you can see the value in improving your process of care, and how the AUC can be utilized to actually identify appropriate patient referral patterns and track your success. This is increasingly going to be a performance metric. Your rating for appropriate test candidates is going to be used as a quality metric," she explained.

The educational portion of the Excellence in Imaging campaign will not only include continuing medical education that is designed to raise the quality of imaging by ASNC members, but also webinars for referring physicians aimed at fostering appropriate referral patterns. Clinical decision support tools are being developed that can be embedded in smart phones to assist referring physicians in selecting the optimal test for a given patient, rather than leaving the testing decision to be made downstream when the patient arrives at the nuclear cardiology clinic. There will also be public education efforts to dispel widespread misconceptions about radiation safety.

Later, Dr. Manuel D. Cerqueira observed that shifting the timing of appropriate test decision making to the point when testing is ordered by referring physicians is "easy to say, hard to do."

No matter how many conversations he has with emergency department physicians at outlying hospitals about not sending him low-risk, inappropriate candidates for imaging procedures involving ionizing radiation exposure when there are better nonradioactive tests available, they continue to do so.

"They’re worried about liability, they’re worried about their 1-year contract that gets reviewed by the hospital, and they’re worried about the pressure the hospital puts on them to do more procedures that are lucrative for the hospital," said Dr. Cerqueira, professor of radiology and medicine and chairman of the nuclear medicine imaging institute at the Cleveland Clinic Foundation.

In a separate presentation, Dr. Robert C. Hendel, who chaired the writing group for the updated MPI AUC, said a dozen studies presented in the past 5 years demonstrate that 10%-15% of all MPIs are inappropriate, as defined by the AUC.

"Basically, if it’s an inappropriate indication, by definition the risks exceed the benefits. The best radiation safety we can do is not to perform the test – not to expose the patient – when it’s not necessary," explained Dr. Hendel, professor of medicine and radiology and director of cardiac imaging and outpatient services at the University of Miami.

He led a six-center study called SPECT-MPI involving roughly 6,000 consecutive patients who underwent single photon emission CT. Overall, inappropriate use of the procedure occurred in 14.4% of patients, with rates ranging from 4% to 22% among the practices.

The SPECT-MPI study identified the major problem areas for inappropriate utilization. Topping the list was the use of MPI to detect CAD in asymptomatic patients at low risk for coronary heart disease; this accounted for 45% of all inappropriate tests and 6% of total testing.

The five most common inappropriate-use indications accounted for 92% of all inappropriate tests. If all testing done for these five inappropriate reasons were to be eliminated, total imaging volume would be reduced by 12.4% (J. Am. Coll. Cardiol. 2010;55:156-62).

"Imaging in Focus" is an ACC-sponsored national quality improvement initiative aimed at helping cardiovascular physicians to reduce inappropriate imaging in a collaborative, nonconfrontational way through the use of webinars, blogs, and other tools. It’s designed as a learning community whose stated goal is to achieve a 50% reduction in inappropriate cardiovascular imaging in 3 years. Dr. Hendel announced some good news: The program has already resoundingly surpassed that target. In just its first year of operation, imaging centers participating in Imaging in Focus reduced their inappropriate imaging by 50% from a baseline rate of 10%.

"This is very exciting," he said.

None of the speakers had relevant financial interests.

DENVER – The majority of nuclear cardiology labs are not utilizing the American College of Cardiology appropriate use criteria for myocardial perfusion imaging, according to the preliminary results of an American Society of Nuclear Cardiology membership survey.

The revelation that only 48% of nuclear cardiology imaging labs employ the ACC appropriate use criteria is disturbing. It comes at a time when nuclear cardiologists are already drawing heat from payers, clinicians, patients, and Congress for perceived overutilization of testing and a casual attitude toward patient exposure to radiation.

The ACC’s appropriate use criteria (AUC) program is a high-profile quality improvement initiative. The myocardial perfusion imaging AUC were developed jointly by the ACC, ASNC, and other key specialty societies. Myocardial perfusion imaging (MPI) was the first topic selected for the program, which has since gone on to develop AUC for other common cardiovascular tests and procedures. MPI was selected to go first because of concerns raised by the explosive growth and substantial regional variation in the procedures. The initial version of the MPI AUC was published in 2005, with an updated rendition appearing 2 years ago (J. Am. Coll. Cardiol. 2009;53:2201-9).

ASNC President Leslee J. Shaw, Ph.D., presented the preliminary membership survey results during her presidential address at the annual meeting of the American Society of Nuclear Cardiology. She also took that occasion to unveil an ambitious new multifaceted ASNC campaign called "Excellence in Imaging." The program is designed to improve the practice of nuclear cardiology through education and advocacy, and by fostering high-quality research that demonstrates nuclear imaging’s clinical value. ASNC members who take the Excellence in Imaging pledge commit themselves to following the AUC.

"By taking a proactive stance on defining quality in nuclear cardiology and demonstrating our members’ commitment to these defined quality measures, ASNC will lead the discussion about appropriate use and set the standards by which our patients receive optimal care," promised Dr. Shaw, professor of medicine at Emory University, Atlanta.

"What the survey results say to me is that we need to do a better job of providing you with tools where you can see the value in improving your process of care, and how the AUC can be utilized to actually identify appropriate patient referral patterns and track your success. This is increasingly going to be a performance metric. Your rating for appropriate test candidates is going to be used as a quality metric," she explained.

The educational portion of the Excellence in Imaging campaign will not only include continuing medical education that is designed to raise the quality of imaging by ASNC members, but also webinars for referring physicians aimed at fostering appropriate referral patterns. Clinical decision support tools are being developed that can be embedded in smart phones to assist referring physicians in selecting the optimal test for a given patient, rather than leaving the testing decision to be made downstream when the patient arrives at the nuclear cardiology clinic. There will also be public education efforts to dispel widespread misconceptions about radiation safety.

Later, Dr. Manuel D. Cerqueira observed that shifting the timing of appropriate test decision making to the point when testing is ordered by referring physicians is "easy to say, hard to do."

No matter how many conversations he has with emergency department physicians at outlying hospitals about not sending him low-risk, inappropriate candidates for imaging procedures involving ionizing radiation exposure when there are better nonradioactive tests available, they continue to do so.

"They’re worried about liability, they’re worried about their 1-year contract that gets reviewed by the hospital, and they’re worried about the pressure the hospital puts on them to do more procedures that are lucrative for the hospital," said Dr. Cerqueira, professor of radiology and medicine and chairman of the nuclear medicine imaging institute at the Cleveland Clinic Foundation.

In a separate presentation, Dr. Robert C. Hendel, who chaired the writing group for the updated MPI AUC, said a dozen studies presented in the past 5 years demonstrate that 10%-15% of all MPIs are inappropriate, as defined by the AUC.

"Basically, if it’s an inappropriate indication, by definition the risks exceed the benefits. The best radiation safety we can do is not to perform the test – not to expose the patient – when it’s not necessary," explained Dr. Hendel, professor of medicine and radiology and director of cardiac imaging and outpatient services at the University of Miami.

He led a six-center study called SPECT-MPI involving roughly 6,000 consecutive patients who underwent single photon emission CT. Overall, inappropriate use of the procedure occurred in 14.4% of patients, with rates ranging from 4% to 22% among the practices.

The SPECT-MPI study identified the major problem areas for inappropriate utilization. Topping the list was the use of MPI to detect CAD in asymptomatic patients at low risk for coronary heart disease; this accounted for 45% of all inappropriate tests and 6% of total testing.

The five most common inappropriate-use indications accounted for 92% of all inappropriate tests. If all testing done for these five inappropriate reasons were to be eliminated, total imaging volume would be reduced by 12.4% (J. Am. Coll. Cardiol. 2010;55:156-62).

"Imaging in Focus" is an ACC-sponsored national quality improvement initiative aimed at helping cardiovascular physicians to reduce inappropriate imaging in a collaborative, nonconfrontational way through the use of webinars, blogs, and other tools. It’s designed as a learning community whose stated goal is to achieve a 50% reduction in inappropriate cardiovascular imaging in 3 years. Dr. Hendel announced some good news: The program has already resoundingly surpassed that target. In just its first year of operation, imaging centers participating in Imaging in Focus reduced their inappropriate imaging by 50% from a baseline rate of 10%.

"This is very exciting," he said.

None of the speakers had relevant financial interests.

DENVER – The majority of nuclear cardiology labs are not utilizing the American College of Cardiology appropriate use criteria for myocardial perfusion imaging, according to the preliminary results of an American Society of Nuclear Cardiology membership survey.

The revelation that only 48% of nuclear cardiology imaging labs employ the ACC appropriate use criteria is disturbing. It comes at a time when nuclear cardiologists are already drawing heat from payers, clinicians, patients, and Congress for perceived overutilization of testing and a casual attitude toward patient exposure to radiation.

The ACC’s appropriate use criteria (AUC) program is a high-profile quality improvement initiative. The myocardial perfusion imaging AUC were developed jointly by the ACC, ASNC, and other key specialty societies. Myocardial perfusion imaging (MPI) was the first topic selected for the program, which has since gone on to develop AUC for other common cardiovascular tests and procedures. MPI was selected to go first because of concerns raised by the explosive growth and substantial regional variation in the procedures. The initial version of the MPI AUC was published in 2005, with an updated rendition appearing 2 years ago (J. Am. Coll. Cardiol. 2009;53:2201-9).

ASNC President Leslee J. Shaw, Ph.D., presented the preliminary membership survey results during her presidential address at the annual meeting of the American Society of Nuclear Cardiology. She also took that occasion to unveil an ambitious new multifaceted ASNC campaign called "Excellence in Imaging." The program is designed to improve the practice of nuclear cardiology through education and advocacy, and by fostering high-quality research that demonstrates nuclear imaging’s clinical value. ASNC members who take the Excellence in Imaging pledge commit themselves to following the AUC.

"By taking a proactive stance on defining quality in nuclear cardiology and demonstrating our members’ commitment to these defined quality measures, ASNC will lead the discussion about appropriate use and set the standards by which our patients receive optimal care," promised Dr. Shaw, professor of medicine at Emory University, Atlanta.

"What the survey results say to me is that we need to do a better job of providing you with tools where you can see the value in improving your process of care, and how the AUC can be utilized to actually identify appropriate patient referral patterns and track your success. This is increasingly going to be a performance metric. Your rating for appropriate test candidates is going to be used as a quality metric," she explained.

The educational portion of the Excellence in Imaging campaign will not only include continuing medical education that is designed to raise the quality of imaging by ASNC members, but also webinars for referring physicians aimed at fostering appropriate referral patterns. Clinical decision support tools are being developed that can be embedded in smart phones to assist referring physicians in selecting the optimal test for a given patient, rather than leaving the testing decision to be made downstream when the patient arrives at the nuclear cardiology clinic. There will also be public education efforts to dispel widespread misconceptions about radiation safety.

Later, Dr. Manuel D. Cerqueira observed that shifting the timing of appropriate test decision making to the point when testing is ordered by referring physicians is "easy to say, hard to do."

No matter how many conversations he has with emergency department physicians at outlying hospitals about not sending him low-risk, inappropriate candidates for imaging procedures involving ionizing radiation exposure when there are better nonradioactive tests available, they continue to do so.

"They’re worried about liability, they’re worried about their 1-year contract that gets reviewed by the hospital, and they’re worried about the pressure the hospital puts on them to do more procedures that are lucrative for the hospital," said Dr. Cerqueira, professor of radiology and medicine and chairman of the nuclear medicine imaging institute at the Cleveland Clinic Foundation.

In a separate presentation, Dr. Robert C. Hendel, who chaired the writing group for the updated MPI AUC, said a dozen studies presented in the past 5 years demonstrate that 10%-15% of all MPIs are inappropriate, as defined by the AUC.

"Basically, if it’s an inappropriate indication, by definition the risks exceed the benefits. The best radiation safety we can do is not to perform the test – not to expose the patient – when it’s not necessary," explained Dr. Hendel, professor of medicine and radiology and director of cardiac imaging and outpatient services at the University of Miami.

He led a six-center study called SPECT-MPI involving roughly 6,000 consecutive patients who underwent single photon emission CT. Overall, inappropriate use of the procedure occurred in 14.4% of patients, with rates ranging from 4% to 22% among the practices.

The SPECT-MPI study identified the major problem areas for inappropriate utilization. Topping the list was the use of MPI to detect CAD in asymptomatic patients at low risk for coronary heart disease; this accounted for 45% of all inappropriate tests and 6% of total testing.

The five most common inappropriate-use indications accounted for 92% of all inappropriate tests. If all testing done for these five inappropriate reasons were to be eliminated, total imaging volume would be reduced by 12.4% (J. Am. Coll. Cardiol. 2010;55:156-62).

"Imaging in Focus" is an ACC-sponsored national quality improvement initiative aimed at helping cardiovascular physicians to reduce inappropriate imaging in a collaborative, nonconfrontational way through the use of webinars, blogs, and other tools. It’s designed as a learning community whose stated goal is to achieve a 50% reduction in inappropriate cardiovascular imaging in 3 years. Dr. Hendel announced some good news: The program has already resoundingly surpassed that target. In just its first year of operation, imaging centers participating in Imaging in Focus reduced their inappropriate imaging by 50% from a baseline rate of 10%.

"This is very exciting," he said.

None of the speakers had relevant financial interests.

DENVER – Once-yearly intravenous zoledronic acid in men with osteoporosis reduced their risk of vertebral fractures by 67% over 2 years, compared with placebo, in a large, multinational, phase III, randomized clinical trial.

"This is the first clear demonstration of antifracture efficacy for an osteoporosis agent in male osteoporosis," said Dr. Steven Boonen in presenting the study results at the annual meeting of the American Society for Bone and Mineral Research.

"These findings suggest the use of zoledronic acid as a treatment option in male patients, particularly because annual infusions ensure that patients will have the full effect of treatment for at least the next year," added Dr. Boonen, professor of geriatric medicine and head of the gerontology and geriatrics section at Catholic University of Leuven (Belgium).

He reported on 1,199 men (mean age, 66 years) with primary osteoporosis or osteoporosis secondary to hypogonadism who were randomized in a double-blind fashion to a once-yearly 15-minute infusion of 5 mg of zoledronic acid (Reclast) or placebo at 134 centers. At enrollment, 32% of the men had one or more vertebral fractures.

The primary study end point was the proportion of subjects with one or more new vertebral fractures during 2 years of follow-up. The rate was 1.6% in men assigned to zoledronic acid and 4.9% in placebo-treated controls, which translated to a highly significant 67% relative risk reduction. The 12-month rate was 0.9% in the zoledronic acid group vs. 2.8% in controls, for a 68% relative risk reduction.

The incidence of moderate to severe vertebral fractures was similarly reduced by 63% in zoledronic acid recipients, compared with controls.

Men on zoledronic acid had a stable 60% reduction in levels of the bone turnover biomarker CTx, compared with the placebo group, throughout the study.

At 2 years, bone mineral density was roughly 6% greater at the spine and 2% greater at the total hip in the zoledronic acid group, compared with controls.

"All of these findings are remarkably similar in magnitude to the risk reductions that have been documented with zoledronic acid in the pivotal fracture trial in postmenopausal osteoporosis," the geriatrician observed.

Men on zoledronic acid also experienced a smaller height loss, compared with controls (mean, 2.34 vs. 4.49 mm).

No major safety issues arose in the study. Similar numbers of patients in both study arms dropped out of the trial because of adverse events.

At present, zoledronic acid’s approved indications include treatment to increase bone mass in men with osteoporosis.

Dr. Boonen disclosed that he has received research grants from and serves as a consultant to Novartis.

DENVER – Once-yearly intravenous zoledronic acid in men with osteoporosis reduced their risk of vertebral fractures by 67% over 2 years, compared with placebo, in a large, multinational, phase III, randomized clinical trial.

"This is the first clear demonstration of antifracture efficacy for an osteoporosis agent in male osteoporosis," said Dr. Steven Boonen in presenting the study results at the annual meeting of the American Society for Bone and Mineral Research.

"These findings suggest the use of zoledronic acid as a treatment option in male patients, particularly because annual infusions ensure that patients will have the full effect of treatment for at least the next year," added Dr. Boonen, professor of geriatric medicine and head of the gerontology and geriatrics section at Catholic University of Leuven (Belgium).

He reported on 1,199 men (mean age, 66 years) with primary osteoporosis or osteoporosis secondary to hypogonadism who were randomized in a double-blind fashion to a once-yearly 15-minute infusion of 5 mg of zoledronic acid (Reclast) or placebo at 134 centers. At enrollment, 32% of the men had one or more vertebral fractures.

The primary study end point was the proportion of subjects with one or more new vertebral fractures during 2 years of follow-up. The rate was 1.6% in men assigned to zoledronic acid and 4.9% in placebo-treated controls, which translated to a highly significant 67% relative risk reduction. The 12-month rate was 0.9% in the zoledronic acid group vs. 2.8% in controls, for a 68% relative risk reduction.

The incidence of moderate to severe vertebral fractures was similarly reduced by 63% in zoledronic acid recipients, compared with controls.

Men on zoledronic acid had a stable 60% reduction in levels of the bone turnover biomarker CTx, compared with the placebo group, throughout the study.

At 2 years, bone mineral density was roughly 6% greater at the spine and 2% greater at the total hip in the zoledronic acid group, compared with controls.

"All of these findings are remarkably similar in magnitude to the risk reductions that have been documented with zoledronic acid in the pivotal fracture trial in postmenopausal osteoporosis," the geriatrician observed.

Men on zoledronic acid also experienced a smaller height loss, compared with controls (mean, 2.34 vs. 4.49 mm).

No major safety issues arose in the study. Similar numbers of patients in both study arms dropped out of the trial because of adverse events.

At present, zoledronic acid’s approved indications include treatment to increase bone mass in men with osteoporosis.

Dr. Boonen disclosed that he has received research grants from and serves as a consultant to Novartis.

DENVER – Once-yearly intravenous zoledronic acid in men with osteoporosis reduced their risk of vertebral fractures by 67% over 2 years, compared with placebo, in a large, multinational, phase III, randomized clinical trial.

"This is the first clear demonstration of antifracture efficacy for an osteoporosis agent in male osteoporosis," said Dr. Steven Boonen in presenting the study results at the annual meeting of the American Society for Bone and Mineral Research.

"These findings suggest the use of zoledronic acid as a treatment option in male patients, particularly because annual infusions ensure that patients will have the full effect of treatment for at least the next year," added Dr. Boonen, professor of geriatric medicine and head of the gerontology and geriatrics section at Catholic University of Leuven (Belgium).

He reported on 1,199 men (mean age, 66 years) with primary osteoporosis or osteoporosis secondary to hypogonadism who were randomized in a double-blind fashion to a once-yearly 15-minute infusion of 5 mg of zoledronic acid (Reclast) or placebo at 134 centers. At enrollment, 32% of the men had one or more vertebral fractures.

The primary study end point was the proportion of subjects with one or more new vertebral fractures during 2 years of follow-up. The rate was 1.6% in men assigned to zoledronic acid and 4.9% in placebo-treated controls, which translated to a highly significant 67% relative risk reduction. The 12-month rate was 0.9% in the zoledronic acid group vs. 2.8% in controls, for a 68% relative risk reduction.

The incidence of moderate to severe vertebral fractures was similarly reduced by 63% in zoledronic acid recipients, compared with controls.

Men on zoledronic acid had a stable 60% reduction in levels of the bone turnover biomarker CTx, compared with the placebo group, throughout the study.

At 2 years, bone mineral density was roughly 6% greater at the spine and 2% greater at the total hip in the zoledronic acid group, compared with controls.

"All of these findings are remarkably similar in magnitude to the risk reductions that have been documented with zoledronic acid in the pivotal fracture trial in postmenopausal osteoporosis," the geriatrician observed.

Men on zoledronic acid also experienced a smaller height loss, compared with controls (mean, 2.34 vs. 4.49 mm).

No major safety issues arose in the study. Similar numbers of patients in both study arms dropped out of the trial because of adverse events.

At present, zoledronic acid’s approved indications include treatment to increase bone mass in men with osteoporosis.

Dr. Boonen disclosed that he has received research grants from and serves as a consultant to Novartis.