Osteoarthritis

SAN ANTONIO — Intact human recombinant parathyroid hormone prevented both recurrent and first fractures in a multinational, randomized, placebo-controlled study of postmenopausal women with osteoporosis, Mark P. Ettinger, M.D., said at the annual meeting of the American College of Rheumatology.

Previous studies have shown that the parathyroid hormone (PTH) analog teriperatide can prevent fractures in patients with advanced disease who already have had a fracture. The Treatment of Osteoporosis With PTH (TOP) study was the first to demonstrate the prevention of first fractures in patients with earlier disease, Dr. Ettinger said.

“This is extremely important, because the presence of any existing fracture greatly increases the risk of subsequent fractures,” he said in a late-breaking abstract session.

The TOP study included 2,532 women whose mean age was 64.4 years and whose mean spine, total hip, and femoral neck bone mineral density (BMD) T-scores were -3.0, -1.9, and -2.2, respectively.

The study population was very different from other osteoporosis treatment cohorts, in that the patients were younger, and only 19% already had fractures. In previous trials, fracture prevalence ranged from 37% to 100%, he said.

Patients were randomized to 100 mcg of subcutaneous PTH or placebo daily. All patients also took 700 mg calcium and 400 U vitamin D each day. A total of 1,737 patients completed the 18-month study.

At study completion, the vertebral fracture incidence was 3.3% in the placebo group and 1.1% in the PTH group, which represented a relative fracture risk reduction of 66%, said Dr. Ettinger, medical director emeritus of Radiant Research, Stuart, Fla.

In a per-protocol analysis, patients who had a fracture before entering the study had a 69% relative fracture risk reduction; those without a previous fracture had a risk reduction of 63%. At month 18 the mean spine, total hip, and femoral neck BMD had increased by 7.2%, 2.2%, and 2.5%, respectively, in the PTH group relative to the placebo group, he said.

About 9% of the PTH group withdrew because of headache, dizziness, nausea, or vomiting, or elevated serum or urine calcium levels. Overall, 16% of PTH patients and 12% of placebo patients withdrew during the course of the study. There were two deaths in the placebo group and one in the PTH group; this was judged to be unrelated to treatment.

“The results of the TOP study may change our treatment paradigm,” said Dr. Ettinger who disclosed that he received research grants and consulting fees from many pharmaceutical companies including NPS Pharmaceuticals, the Salt Lake City-based manufacturer of PTH.

SAN ANTONIO — Intact human recombinant parathyroid hormone prevented both recurrent and first fractures in a multinational, randomized, placebo-controlled study of postmenopausal women with osteoporosis, Mark P. Ettinger, M.D., said at the annual meeting of the American College of Rheumatology.

Previous studies have shown that the parathyroid hormone (PTH) analog teriperatide can prevent fractures in patients with advanced disease who already have had a fracture. The Treatment of Osteoporosis With PTH (TOP) study was the first to demonstrate the prevention of first fractures in patients with earlier disease, Dr. Ettinger said.

“This is extremely important, because the presence of any existing fracture greatly increases the risk of subsequent fractures,” he said in a late-breaking abstract session.

The TOP study included 2,532 women whose mean age was 64.4 years and whose mean spine, total hip, and femoral neck bone mineral density (BMD) T-scores were -3.0, -1.9, and -2.2, respectively.

The study population was very different from other osteoporosis treatment cohorts, in that the patients were younger, and only 19% already had fractures. In previous trials, fracture prevalence ranged from 37% to 100%, he said.

Patients were randomized to 100 mcg of subcutaneous PTH or placebo daily. All patients also took 700 mg calcium and 400 U vitamin D each day. A total of 1,737 patients completed the 18-month study.

At study completion, the vertebral fracture incidence was 3.3% in the placebo group and 1.1% in the PTH group, which represented a relative fracture risk reduction of 66%, said Dr. Ettinger, medical director emeritus of Radiant Research, Stuart, Fla.

In a per-protocol analysis, patients who had a fracture before entering the study had a 69% relative fracture risk reduction; those without a previous fracture had a risk reduction of 63%. At month 18 the mean spine, total hip, and femoral neck BMD had increased by 7.2%, 2.2%, and 2.5%, respectively, in the PTH group relative to the placebo group, he said.

About 9% of the PTH group withdrew because of headache, dizziness, nausea, or vomiting, or elevated serum or urine calcium levels. Overall, 16% of PTH patients and 12% of placebo patients withdrew during the course of the study. There were two deaths in the placebo group and one in the PTH group; this was judged to be unrelated to treatment.

“The results of the TOP study may change our treatment paradigm,” said Dr. Ettinger who disclosed that he received research grants and consulting fees from many pharmaceutical companies including NPS Pharmaceuticals, the Salt Lake City-based manufacturer of PTH.

SAN ANTONIO — Intact human recombinant parathyroid hormone prevented both recurrent and first fractures in a multinational, randomized, placebo-controlled study of postmenopausal women with osteoporosis, Mark P. Ettinger, M.D., said at the annual meeting of the American College of Rheumatology.

Previous studies have shown that the parathyroid hormone (PTH) analog teriperatide can prevent fractures in patients with advanced disease who already have had a fracture. The Treatment of Osteoporosis With PTH (TOP) study was the first to demonstrate the prevention of first fractures in patients with earlier disease, Dr. Ettinger said.

“This is extremely important, because the presence of any existing fracture greatly increases the risk of subsequent fractures,” he said in a late-breaking abstract session.

The TOP study included 2,532 women whose mean age was 64.4 years and whose mean spine, total hip, and femoral neck bone mineral density (BMD) T-scores were -3.0, -1.9, and -2.2, respectively.

The study population was very different from other osteoporosis treatment cohorts, in that the patients were younger, and only 19% already had fractures. In previous trials, fracture prevalence ranged from 37% to 100%, he said.

Patients were randomized to 100 mcg of subcutaneous PTH or placebo daily. All patients also took 700 mg calcium and 400 U vitamin D each day. A total of 1,737 patients completed the 18-month study.

At study completion, the vertebral fracture incidence was 3.3% in the placebo group and 1.1% in the PTH group, which represented a relative fracture risk reduction of 66%, said Dr. Ettinger, medical director emeritus of Radiant Research, Stuart, Fla.

In a per-protocol analysis, patients who had a fracture before entering the study had a 69% relative fracture risk reduction; those without a previous fracture had a risk reduction of 63%. At month 18 the mean spine, total hip, and femoral neck BMD had increased by 7.2%, 2.2%, and 2.5%, respectively, in the PTH group relative to the placebo group, he said.

About 9% of the PTH group withdrew because of headache, dizziness, nausea, or vomiting, or elevated serum or urine calcium levels. Overall, 16% of PTH patients and 12% of placebo patients withdrew during the course of the study. There were two deaths in the placebo group and one in the PTH group; this was judged to be unrelated to treatment.

“The results of the TOP study may change our treatment paradigm,” said Dr. Ettinger who disclosed that he received research grants and consulting fees from many pharmaceutical companies including NPS Pharmaceuticals, the Salt Lake City-based manufacturer of PTH.

The American Pain Foundation's TARGET Chronic Pain initiative is offering free tools to improve communication between patients and clinicians. The TARGET Chronic Pain Notebook helps patients track pain, and the TARGET Chronic Pain Card provides tips for clinicians. Both are available online at www.painfoundation.org

The American Pain Foundation's TARGET Chronic Pain initiative is offering free tools to improve communication between patients and clinicians. The TARGET Chronic Pain Notebook helps patients track pain, and the TARGET Chronic Pain Card provides tips for clinicians. Both are available online at www.painfoundation.org

The American Pain Foundation's TARGET Chronic Pain initiative is offering free tools to improve communication between patients and clinicians. The TARGET Chronic Pain Notebook helps patients track pain, and the TARGET Chronic Pain Card provides tips for clinicians. Both are available online at www.painfoundation.org

HARROGATE, ENGLAND — Age and frailty should not deter offering very elderly osteoporotic patients antiresorptive therapy, despite age-associated increases in comorbid conditions, said Steven Boonen, M.D.

The results of a pooled analysis from three randomized, double-blind controlled trials showed a significantly reduced risk of new vertebral fractures among 704 osteoporotic women aged 80 and older who received bisphosphonate therapy, compared with age-and disease-matched patients randomized to placebo treatment, Dr. Boonen reported in a presentation at the annual conference of the National Osteoporosis Society.

“To the best of our knowledge, this study is the first to document a benefit of antiresorptive treatment in addition to that afforded by calcium and vitamin D in a population of women aged 80 and older with osteoporosis,” said Dr. Boonen of Leuven (Belgium) University Center for Metabolic Bone Disease, the study's principal investigator. “The findings tell us that, even in the very old, reducing bone resorption rates remains an effective treatment strategy,” he said.

The three studies each looked at 3-year fracture end points and included women aged 80-100 years with documented osteoporosis. In each study, the women randomized to bisphosphonate therapy were prescribed 5 mg/day of risedronate (Actonel) for up to 3 years, and control group patients were given a placebo pill for the same duration. All participants received 1,000 mg calcium supplementation per day and, if baseline levels were low, up to 500 U of vitamin D per day.

At 1 year, the risedronate groups had a new vertebral fracture rate of 2.5%, compared with 10.9% for the control groups. At 3 years, the new vertebral fracture rates for the bisphosphonate and placebo groups were 18.2% and 24.6%, respectively, “representing a 44% reduction in risk for the women who took risedronate,” said Dr. Boonen.

The rates of nonvertebral fractures were not significantly different between the two groups, Dr. Boonen stated. At 3 years, the risedronate patients had a 14% risk, compared with the placebo group's 16.2% risk. The studies also showed risedronate to have a safety profile similar to that of placebo.

The early efficacy of the risedronate therapy was consistent across the three trials, said Dr. Boonen. The treatment was well tolerated, even among the oldest women in the study population.

The hope is that these data will help increase the number of “very old” patients with osteoporotic fractures who are deemed eligible for and who receive treatment. “Despite the debilitating effects of osteoporotic fractures and the availability of therapies to reduce fracture recurrence, only a small percentage of women with osteoporotic fractures receive treatment, and this percentage decreases with age,” Dr. Boonen said. “Clinicians may presume that it is too late to alter the course of disease in its late stage, but these results tell us that is not so.”

Each of the antiresorptive therapies has unique characteristics and side-effect profiles. The observations made in this study cannot be generalized to include other bisphosphonates, Dr. Boonen cautioned.

He disclosed that he has received research grants from Procter and Gamble Pharmaceuticals but has no other financial relationship with it or any other company that markets bisphosphonates.

HARROGATE, ENGLAND — Age and frailty should not deter offering very elderly osteoporotic patients antiresorptive therapy, despite age-associated increases in comorbid conditions, said Steven Boonen, M.D.

The results of a pooled analysis from three randomized, double-blind controlled trials showed a significantly reduced risk of new vertebral fractures among 704 osteoporotic women aged 80 and older who received bisphosphonate therapy, compared with age-and disease-matched patients randomized to placebo treatment, Dr. Boonen reported in a presentation at the annual conference of the National Osteoporosis Society.

“To the best of our knowledge, this study is the first to document a benefit of antiresorptive treatment in addition to that afforded by calcium and vitamin D in a population of women aged 80 and older with osteoporosis,” said Dr. Boonen of Leuven (Belgium) University Center for Metabolic Bone Disease, the study's principal investigator. “The findings tell us that, even in the very old, reducing bone resorption rates remains an effective treatment strategy,” he said.

The three studies each looked at 3-year fracture end points and included women aged 80-100 years with documented osteoporosis. In each study, the women randomized to bisphosphonate therapy were prescribed 5 mg/day of risedronate (Actonel) for up to 3 years, and control group patients were given a placebo pill for the same duration. All participants received 1,000 mg calcium supplementation per day and, if baseline levels were low, up to 500 U of vitamin D per day.

At 1 year, the risedronate groups had a new vertebral fracture rate of 2.5%, compared with 10.9% for the control groups. At 3 years, the new vertebral fracture rates for the bisphosphonate and placebo groups were 18.2% and 24.6%, respectively, “representing a 44% reduction in risk for the women who took risedronate,” said Dr. Boonen.

The rates of nonvertebral fractures were not significantly different between the two groups, Dr. Boonen stated. At 3 years, the risedronate patients had a 14% risk, compared with the placebo group's 16.2% risk. The studies also showed risedronate to have a safety profile similar to that of placebo.

The early efficacy of the risedronate therapy was consistent across the three trials, said Dr. Boonen. The treatment was well tolerated, even among the oldest women in the study population.

The hope is that these data will help increase the number of “very old” patients with osteoporotic fractures who are deemed eligible for and who receive treatment. “Despite the debilitating effects of osteoporotic fractures and the availability of therapies to reduce fracture recurrence, only a small percentage of women with osteoporotic fractures receive treatment, and this percentage decreases with age,” Dr. Boonen said. “Clinicians may presume that it is too late to alter the course of disease in its late stage, but these results tell us that is not so.”

Each of the antiresorptive therapies has unique characteristics and side-effect profiles. The observations made in this study cannot be generalized to include other bisphosphonates, Dr. Boonen cautioned.

He disclosed that he has received research grants from Procter and Gamble Pharmaceuticals but has no other financial relationship with it or any other company that markets bisphosphonates.

HARROGATE, ENGLAND — Age and frailty should not deter offering very elderly osteoporotic patients antiresorptive therapy, despite age-associated increases in comorbid conditions, said Steven Boonen, M.D.

The results of a pooled analysis from three randomized, double-blind controlled trials showed a significantly reduced risk of new vertebral fractures among 704 osteoporotic women aged 80 and older who received bisphosphonate therapy, compared with age-and disease-matched patients randomized to placebo treatment, Dr. Boonen reported in a presentation at the annual conference of the National Osteoporosis Society.

“To the best of our knowledge, this study is the first to document a benefit of antiresorptive treatment in addition to that afforded by calcium and vitamin D in a population of women aged 80 and older with osteoporosis,” said Dr. Boonen of Leuven (Belgium) University Center for Metabolic Bone Disease, the study's principal investigator. “The findings tell us that, even in the very old, reducing bone resorption rates remains an effective treatment strategy,” he said.

The three studies each looked at 3-year fracture end points and included women aged 80-100 years with documented osteoporosis. In each study, the women randomized to bisphosphonate therapy were prescribed 5 mg/day of risedronate (Actonel) for up to 3 years, and control group patients were given a placebo pill for the same duration. All participants received 1,000 mg calcium supplementation per day and, if baseline levels were low, up to 500 U of vitamin D per day.

At 1 year, the risedronate groups had a new vertebral fracture rate of 2.5%, compared with 10.9% for the control groups. At 3 years, the new vertebral fracture rates for the bisphosphonate and placebo groups were 18.2% and 24.6%, respectively, “representing a 44% reduction in risk for the women who took risedronate,” said Dr. Boonen.

The rates of nonvertebral fractures were not significantly different between the two groups, Dr. Boonen stated. At 3 years, the risedronate patients had a 14% risk, compared with the placebo group's 16.2% risk. The studies also showed risedronate to have a safety profile similar to that of placebo.

The early efficacy of the risedronate therapy was consistent across the three trials, said Dr. Boonen. The treatment was well tolerated, even among the oldest women in the study population.

The hope is that these data will help increase the number of “very old” patients with osteoporotic fractures who are deemed eligible for and who receive treatment. “Despite the debilitating effects of osteoporotic fractures and the availability of therapies to reduce fracture recurrence, only a small percentage of women with osteoporotic fractures receive treatment, and this percentage decreases with age,” Dr. Boonen said. “Clinicians may presume that it is too late to alter the course of disease in its late stage, but these results tell us that is not so.”

Each of the antiresorptive therapies has unique characteristics and side-effect profiles. The observations made in this study cannot be generalized to include other bisphosphonates, Dr. Boonen cautioned.

He disclosed that he has received research grants from Procter and Gamble Pharmaceuticals but has no other financial relationship with it or any other company that markets bisphosphonates.

HARROGATE, ENGLAND — A single bone mineral density measurement early in menopause is a strong predictor of future bone status in women not considered at risk for osteoporosis, a study has shown.

Despite various rates of bone mineral loss among individuals and measurement sites, baseline bone mineral density measures of 766 women from the Danish Osteoporosis Prevention Study predicted 75% of the variation in lumbar spine bone mineral density and 74% of femoral neck bone minderal density variation over 10 years, reported Bo Abrahamsen, M.D., at the annual conference of the National Osteoporosis Society.

None of the women in the investigation were receiving hormone therapy or treatment with antiresorptive drugs.

The baseline scans were acquired within 2 years of menopause.

Baseline lumbar spine T-scores greater than -1.2 were associated with a 90% negative predictive value for developing osteoporosis over the course of 10 years.

However, a lumbar spine T-score greater than 0.5 had a negative predictive value of 100%.

A baseline femoral neck T-score greater than -1.7 had a 90% negative predictive value for femoral neck osteoporosis.

“No women developed femoral neck osteoporosis in the absence of baseline femoral neck osteopenia,” said Dr. Abrahamsen of Odense (Denmark) University Hospital.

At baseline, having a lumbar spine T-score greater than -1.0 or a femoral neck T-score greater than -0.5 was associated with a 90% negative predictive value for osteoporosis of the lumbar spine and/or the femoral neck.

“Women with lumbar spine osteopenia at baseline had a 46% risk for developing osteoporosis of the femoral neck or lumbar spine,” explained Dr. Abrahamsen.

At the same time, fewer than 10% of women whose T-scores of the spine or femoral neck dipped below -2.5 within 10 years had spinal osteopenia at their initial visit, he said.

The findings support the role of bone density measurements in the first years after menopause, Dr. Abrahamsen said.

“There is an increasing demand for [bone density measurement] with the onset of menopause due to concerns about the safety of hormone replacement therapy and a possible need for considering other treatment,” he said.

“We know that, despite the fact that the average rate of bone mineral loss is only a few percent per year, there is much individual variation in those rates,” Dr. Abrahamsen said.

“These results tell us that much of the variation in future bone mineral density can be predicted by baseline bone mineral density,” Dr. Abrahamsen added.

As such, baseline measures should be considered for long-term treatment planning, Dr. Abrahamsen concluded.

HARROGATE, ENGLAND — A single bone mineral density measurement early in menopause is a strong predictor of future bone status in women not considered at risk for osteoporosis, a study has shown.

Despite various rates of bone mineral loss among individuals and measurement sites, baseline bone mineral density measures of 766 women from the Danish Osteoporosis Prevention Study predicted 75% of the variation in lumbar spine bone mineral density and 74% of femoral neck bone minderal density variation over 10 years, reported Bo Abrahamsen, M.D., at the annual conference of the National Osteoporosis Society.

None of the women in the investigation were receiving hormone therapy or treatment with antiresorptive drugs.

The baseline scans were acquired within 2 years of menopause.

Baseline lumbar spine T-scores greater than -1.2 were associated with a 90% negative predictive value for developing osteoporosis over the course of 10 years.

However, a lumbar spine T-score greater than 0.5 had a negative predictive value of 100%.

A baseline femoral neck T-score greater than -1.7 had a 90% negative predictive value for femoral neck osteoporosis.

“No women developed femoral neck osteoporosis in the absence of baseline femoral neck osteopenia,” said Dr. Abrahamsen of Odense (Denmark) University Hospital.

At baseline, having a lumbar spine T-score greater than -1.0 or a femoral neck T-score greater than -0.5 was associated with a 90% negative predictive value for osteoporosis of the lumbar spine and/or the femoral neck.

“Women with lumbar spine osteopenia at baseline had a 46% risk for developing osteoporosis of the femoral neck or lumbar spine,” explained Dr. Abrahamsen.

At the same time, fewer than 10% of women whose T-scores of the spine or femoral neck dipped below -2.5 within 10 years had spinal osteopenia at their initial visit, he said.

The findings support the role of bone density measurements in the first years after menopause, Dr. Abrahamsen said.

“There is an increasing demand for [bone density measurement] with the onset of menopause due to concerns about the safety of hormone replacement therapy and a possible need for considering other treatment,” he said.

“We know that, despite the fact that the average rate of bone mineral loss is only a few percent per year, there is much individual variation in those rates,” Dr. Abrahamsen said.

“These results tell us that much of the variation in future bone mineral density can be predicted by baseline bone mineral density,” Dr. Abrahamsen added.

As such, baseline measures should be considered for long-term treatment planning, Dr. Abrahamsen concluded.

HARROGATE, ENGLAND — A single bone mineral density measurement early in menopause is a strong predictor of future bone status in women not considered at risk for osteoporosis, a study has shown.

Despite various rates of bone mineral loss among individuals and measurement sites, baseline bone mineral density measures of 766 women from the Danish Osteoporosis Prevention Study predicted 75% of the variation in lumbar spine bone mineral density and 74% of femoral neck bone minderal density variation over 10 years, reported Bo Abrahamsen, M.D., at the annual conference of the National Osteoporosis Society.

None of the women in the investigation were receiving hormone therapy or treatment with antiresorptive drugs.

The baseline scans were acquired within 2 years of menopause.

Baseline lumbar spine T-scores greater than -1.2 were associated with a 90% negative predictive value for developing osteoporosis over the course of 10 years.

However, a lumbar spine T-score greater than 0.5 had a negative predictive value of 100%.

A baseline femoral neck T-score greater than -1.7 had a 90% negative predictive value for femoral neck osteoporosis.

“No women developed femoral neck osteoporosis in the absence of baseline femoral neck osteopenia,” said Dr. Abrahamsen of Odense (Denmark) University Hospital.

At baseline, having a lumbar spine T-score greater than -1.0 or a femoral neck T-score greater than -0.5 was associated with a 90% negative predictive value for osteoporosis of the lumbar spine and/or the femoral neck.

“Women with lumbar spine osteopenia at baseline had a 46% risk for developing osteoporosis of the femoral neck or lumbar spine,” explained Dr. Abrahamsen.

At the same time, fewer than 10% of women whose T-scores of the spine or femoral neck dipped below -2.5 within 10 years had spinal osteopenia at their initial visit, he said.

The findings support the role of bone density measurements in the first years after menopause, Dr. Abrahamsen said.

“There is an increasing demand for [bone density measurement] with the onset of menopause due to concerns about the safety of hormone replacement therapy and a possible need for considering other treatment,” he said.

“We know that, despite the fact that the average rate of bone mineral loss is only a few percent per year, there is much individual variation in those rates,” Dr. Abrahamsen said.

“These results tell us that much of the variation in future bone mineral density can be predicted by baseline bone mineral density,” Dr. Abrahamsen added.

As such, baseline measures should be considered for long-term treatment planning, Dr. Abrahamsen concluded.

The U.S. Food and Drug Administration has added a black box warning to Depo-Provera to emphasize the potential for bone mineral density loss with long-term use of the injectable contraceptive.

Depo-Provera has been used throughout the world for decades and remains a safe and effective method of birth control, the FDA said in a statement.

However, a recent review of the drug's long-term effects on bone mineral density (BMD) by the FDA and Pfizer Inc., which manufactures the drug, prompted the addition to the label.

The black box warning notes that women who use Depo-Provera may experience a significant decrease in BMD that might not be completely reversible after discontinuing use. Consequently, Depo-Provera should be used as a long-term birth control method (more than 2 years) only if other methods are inadequate.

The warning also states that it's not known whether Depo-Provera use during adolescence or early adulthood will reduce peak bone mass and increase the risk of osteoporotic fracture in later life.

Since the U.S. approval of Depo-Provera in 1992, the prescribing information has included a warning that use of the contraceptive may be considered among the risk factors for development of osteoporosis, Pfizer noted in a statement.

Additional clinical research was initiated in the 1990s to clarify the effects of Depo-Provera on BMD. Results of those studies were considered in the review and led to the labeling revisions.

One of the studies included 540 women aged 25-38 years who used Depo-Provera for 5 years and were then followed for 2 years.

The review also included data from an ongoing investigation of nearly 400 adolescents aged 12-18 years that will end in 2006 after 5 years of treatment and 2 years of follow-up, said Pfizer spokesperson Rebecca Hamm.

Physicians should encourage patients to consider other contraceptive options for long-term use, Ms. Hamm noted.

If women choose to continue using Depo-Provera long-term, physicians should consider periodic BMD tests and advise these patients to take calcium supplements, quit smoking, and engage in moderate exercise to help prevent BMD loss, Ms. Hamm advised.

The U.S. Food and Drug Administration has added a black box warning to Depo-Provera to emphasize the potential for bone mineral density loss with long-term use of the injectable contraceptive.

Depo-Provera has been used throughout the world for decades and remains a safe and effective method of birth control, the FDA said in a statement.

However, a recent review of the drug's long-term effects on bone mineral density (BMD) by the FDA and Pfizer Inc., which manufactures the drug, prompted the addition to the label.

The black box warning notes that women who use Depo-Provera may experience a significant decrease in BMD that might not be completely reversible after discontinuing use. Consequently, Depo-Provera should be used as a long-term birth control method (more than 2 years) only if other methods are inadequate.

The warning also states that it's not known whether Depo-Provera use during adolescence or early adulthood will reduce peak bone mass and increase the risk of osteoporotic fracture in later life.

Since the U.S. approval of Depo-Provera in 1992, the prescribing information has included a warning that use of the contraceptive may be considered among the risk factors for development of osteoporosis, Pfizer noted in a statement.

Additional clinical research was initiated in the 1990s to clarify the effects of Depo-Provera on BMD. Results of those studies were considered in the review and led to the labeling revisions.

One of the studies included 540 women aged 25-38 years who used Depo-Provera for 5 years and were then followed for 2 years.

The review also included data from an ongoing investigation of nearly 400 adolescents aged 12-18 years that will end in 2006 after 5 years of treatment and 2 years of follow-up, said Pfizer spokesperson Rebecca Hamm.

Physicians should encourage patients to consider other contraceptive options for long-term use, Ms. Hamm noted.

If women choose to continue using Depo-Provera long-term, physicians should consider periodic BMD tests and advise these patients to take calcium supplements, quit smoking, and engage in moderate exercise to help prevent BMD loss, Ms. Hamm advised.

The U.S. Food and Drug Administration has added a black box warning to Depo-Provera to emphasize the potential for bone mineral density loss with long-term use of the injectable contraceptive.

Depo-Provera has been used throughout the world for decades and remains a safe and effective method of birth control, the FDA said in a statement.

However, a recent review of the drug's long-term effects on bone mineral density (BMD) by the FDA and Pfizer Inc., which manufactures the drug, prompted the addition to the label.

The black box warning notes that women who use Depo-Provera may experience a significant decrease in BMD that might not be completely reversible after discontinuing use. Consequently, Depo-Provera should be used as a long-term birth control method (more than 2 years) only if other methods are inadequate.

The warning also states that it's not known whether Depo-Provera use during adolescence or early adulthood will reduce peak bone mass and increase the risk of osteoporotic fracture in later life.

Since the U.S. approval of Depo-Provera in 1992, the prescribing information has included a warning that use of the contraceptive may be considered among the risk factors for development of osteoporosis, Pfizer noted in a statement.

Additional clinical research was initiated in the 1990s to clarify the effects of Depo-Provera on BMD. Results of those studies were considered in the review and led to the labeling revisions.

One of the studies included 540 women aged 25-38 years who used Depo-Provera for 5 years and were then followed for 2 years.

The review also included data from an ongoing investigation of nearly 400 adolescents aged 12-18 years that will end in 2006 after 5 years of treatment and 2 years of follow-up, said Pfizer spokesperson Rebecca Hamm.

Physicians should encourage patients to consider other contraceptive options for long-term use, Ms. Hamm noted.

If women choose to continue using Depo-Provera long-term, physicians should consider periodic BMD tests and advise these patients to take calcium supplements, quit smoking, and engage in moderate exercise to help prevent BMD loss, Ms. Hamm advised.

Medicare has agreed to reimburse for vertebral fracture assessment by dual-energy x-ray absorptiometry using the newly approved CPT code 76077, according to the International Society for Clinical Densitometry.

“Vertebral fractures are a powerful barometer in predicting future bone fragility in a patient,” said E. Michael Lewiecki, M.D., osteoporosis director of the New Mexico Clinical Research & Osteoporosis Center in Albuquerque, and president of the ISCD. “The new code gives physicians the opportunity to accurately evaluate a patient's future fracture risk and therefore improve the accuracy of the diagnosis.”

Previous vertebral fracture is a major risk factor for future fragility fractures. “Vertebral fractures are present in about one-third of women over age 65 and are highly related to increased fracture risk at the spine and hip independent of a patient's bone density,” according to Hologic Inc., one of two manufacturers of the dual-energy x-ray absorptiometry (DXA) systems covered under the new code.

Women with such fractures also have less ability to perform daily activities and a significantly higher morbidity, the company added.

Vertebral fracture assessment (VFA) also is a more sensitive measure of identifying osteoporosis than is bone mineral density analysis.

“Based upon BMD alone and the central site measured, 11%-18% of women with vertebral fractures would have been classified as normal,” according to Vance J. Bray, M.D., of the Denver Arthritis Clinic, in a report in the ISCD newsletter, Osteoflash. Such vertebral deformities occur in approximately 11 per 100 women aged 50-59 years and in 54 per 100 women aged 80 years and older, according to Dr. Bray.

The CPT is a continually updated listing of descriptive terms and identifying codes developed and maintained by the American Medical Association, which recently approved implementing the new CPT code for physicians to diagnose vertebral fractures.

Physicians use CPT codes to refer to (and to report providing) medical services and procedures. The CPT is the most widely accepted nomenclature used for service claims under private and public health insurance programs.

Implementation of a new code is recognition of the importance of a new procedure and a vehicle for its inclusion in insurance claims for reimbursement

The ISCD testified to the AMA about the value of this technique to facilitate approval of the new code.

The Health Insurance Portability and Accountability Act of 1996 requires that the most current code be used in all covered health care transactions, and the new code must be used for dates of service as of Jan. 1, 2005.

The Centers for Medicare and Medicaid Services reimbursement for vertebral fracture assessment is set for a national average of about $40, according to Dr. Bray.

Reimbursement for this new imaging technique recognizes its importance, according to the ISCD. “Health care providers will be able to use VFA to select those patients who are at the highest risk for fractures and structure treatment plans to be most beneficial and cost effective,” the organization said.

ISCD is developing educational programs to teach physicians high-quality acquisition and interpretation of vertebral fracture assessment using DXA technology. In February 2005, the ISCD annual meeting in New Orleans will offer an updated bone densitometry class that will incorporate 1-hour VFA introductory lectures for clinicians and technologists.

Criteria for the performance of vertebral fracture assessment are being developed by an ISCD task force and will be discussed at the 2005 ISCD Position Development Conference in Vancouver, B.C., in July, according to Dr. Bray.

DXA has been called the “gold standard” of analysis for measurement of bone mineral density and will continue to be covered by CPT code 76075 for that purpose.

Medicare has agreed to reimburse for vertebral fracture assessment by dual-energy x-ray absorptiometry using the newly approved CPT code 76077, according to the International Society for Clinical Densitometry.

“Vertebral fractures are a powerful barometer in predicting future bone fragility in a patient,” said E. Michael Lewiecki, M.D., osteoporosis director of the New Mexico Clinical Research & Osteoporosis Center in Albuquerque, and president of the ISCD. “The new code gives physicians the opportunity to accurately evaluate a patient's future fracture risk and therefore improve the accuracy of the diagnosis.”

Previous vertebral fracture is a major risk factor for future fragility fractures. “Vertebral fractures are present in about one-third of women over age 65 and are highly related to increased fracture risk at the spine and hip independent of a patient's bone density,” according to Hologic Inc., one of two manufacturers of the dual-energy x-ray absorptiometry (DXA) systems covered under the new code.

Women with such fractures also have less ability to perform daily activities and a significantly higher morbidity, the company added.

Vertebral fracture assessment (VFA) also is a more sensitive measure of identifying osteoporosis than is bone mineral density analysis.

“Based upon BMD alone and the central site measured, 11%-18% of women with vertebral fractures would have been classified as normal,” according to Vance J. Bray, M.D., of the Denver Arthritis Clinic, in a report in the ISCD newsletter, Osteoflash. Such vertebral deformities occur in approximately 11 per 100 women aged 50-59 years and in 54 per 100 women aged 80 years and older, according to Dr. Bray.

The CPT is a continually updated listing of descriptive terms and identifying codes developed and maintained by the American Medical Association, which recently approved implementing the new CPT code for physicians to diagnose vertebral fractures.

Physicians use CPT codes to refer to (and to report providing) medical services and procedures. The CPT is the most widely accepted nomenclature used for service claims under private and public health insurance programs.

Implementation of a new code is recognition of the importance of a new procedure and a vehicle for its inclusion in insurance claims for reimbursement

The ISCD testified to the AMA about the value of this technique to facilitate approval of the new code.

The Health Insurance Portability and Accountability Act of 1996 requires that the most current code be used in all covered health care transactions, and the new code must be used for dates of service as of Jan. 1, 2005.

The Centers for Medicare and Medicaid Services reimbursement for vertebral fracture assessment is set for a national average of about $40, according to Dr. Bray.

Reimbursement for this new imaging technique recognizes its importance, according to the ISCD. “Health care providers will be able to use VFA to select those patients who are at the highest risk for fractures and structure treatment plans to be most beneficial and cost effective,” the organization said.

ISCD is developing educational programs to teach physicians high-quality acquisition and interpretation of vertebral fracture assessment using DXA technology. In February 2005, the ISCD annual meeting in New Orleans will offer an updated bone densitometry class that will incorporate 1-hour VFA introductory lectures for clinicians and technologists.

Criteria for the performance of vertebral fracture assessment are being developed by an ISCD task force and will be discussed at the 2005 ISCD Position Development Conference in Vancouver, B.C., in July, according to Dr. Bray.

DXA has been called the “gold standard” of analysis for measurement of bone mineral density and will continue to be covered by CPT code 76075 for that purpose.

Medicare has agreed to reimburse for vertebral fracture assessment by dual-energy x-ray absorptiometry using the newly approved CPT code 76077, according to the International Society for Clinical Densitometry.

“Vertebral fractures are a powerful barometer in predicting future bone fragility in a patient,” said E. Michael Lewiecki, M.D., osteoporosis director of the New Mexico Clinical Research & Osteoporosis Center in Albuquerque, and president of the ISCD. “The new code gives physicians the opportunity to accurately evaluate a patient's future fracture risk and therefore improve the accuracy of the diagnosis.”

Previous vertebral fracture is a major risk factor for future fragility fractures. “Vertebral fractures are present in about one-third of women over age 65 and are highly related to increased fracture risk at the spine and hip independent of a patient's bone density,” according to Hologic Inc., one of two manufacturers of the dual-energy x-ray absorptiometry (DXA) systems covered under the new code.

Women with such fractures also have less ability to perform daily activities and a significantly higher morbidity, the company added.

Vertebral fracture assessment (VFA) also is a more sensitive measure of identifying osteoporosis than is bone mineral density analysis.

“Based upon BMD alone and the central site measured, 11%-18% of women with vertebral fractures would have been classified as normal,” according to Vance J. Bray, M.D., of the Denver Arthritis Clinic, in a report in the ISCD newsletter, Osteoflash. Such vertebral deformities occur in approximately 11 per 100 women aged 50-59 years and in 54 per 100 women aged 80 years and older, according to Dr. Bray.

The CPT is a continually updated listing of descriptive terms and identifying codes developed and maintained by the American Medical Association, which recently approved implementing the new CPT code for physicians to diagnose vertebral fractures.

Physicians use CPT codes to refer to (and to report providing) medical services and procedures. The CPT is the most widely accepted nomenclature used for service claims under private and public health insurance programs.

Implementation of a new code is recognition of the importance of a new procedure and a vehicle for its inclusion in insurance claims for reimbursement

The ISCD testified to the AMA about the value of this technique to facilitate approval of the new code.

The Health Insurance Portability and Accountability Act of 1996 requires that the most current code be used in all covered health care transactions, and the new code must be used for dates of service as of Jan. 1, 2005.

The Centers for Medicare and Medicaid Services reimbursement for vertebral fracture assessment is set for a national average of about $40, according to Dr. Bray.

Reimbursement for this new imaging technique recognizes its importance, according to the ISCD. “Health care providers will be able to use VFA to select those patients who are at the highest risk for fractures and structure treatment plans to be most beneficial and cost effective,” the organization said.

ISCD is developing educational programs to teach physicians high-quality acquisition and interpretation of vertebral fracture assessment using DXA technology. In February 2005, the ISCD annual meeting in New Orleans will offer an updated bone densitometry class that will incorporate 1-hour VFA introductory lectures for clinicians and technologists.

Criteria for the performance of vertebral fracture assessment are being developed by an ISCD task force and will be discussed at the 2005 ISCD Position Development Conference in Vancouver, B.C., in July, according to Dr. Bray.

DXA has been called the “gold standard” of analysis for measurement of bone mineral density and will continue to be covered by CPT code 76075 for that purpose.