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Pearls on Low Density in the Young, Vertebral Assessment
NEW ORLEANS — Bone health experts offered their share of helpful clinical insights at the annual meeting of the International Society for Clinical Densitometry.
Here are some of the highlights:
Low Bone Density in the Young
Low bone density is not uncommon in young adults but—at least in the short term—does not carry with it the same relative risk of fracture as in older individuals unless secondary causes of metabolic bone disease are identified, said Andrew J. Laster, M.D., a rheumatologist practicing in North Carolina.
Secondary causes of low BMD include endocrinopathies (hypercalciuria, hypogonadism, hyperparathyroidism, and Cushing's syndrome), some GI disorders (gastrectomy, inflammatory bowel disease, celiac disease, intestinal bypass surgery, primary biliary cirrhosis, and pancreatic insufficiency), genetic disorders (Ehlers-Danlos syndrome, Marfan syndrome, and homocystinuria), and eating disorders (anorexia nervosa, bulimia nervosa, and female athlete triad).
Assessing Fracture Risk Factors
Before experts declare the benefits of addressing a particular risk factor in an individual patient, they should stop and ask some key questions, advised John Kanis, M.D., director of the World Health Organization's Collaborating Centre for Metabolic Bone Diseases in Sheffield, England.
The questions are: Is the risk factor internationally validated? Is it feasible for a primary care physician to assess the risk factor? Is the risk factor intuitive?
When to Do Vertebral Assessments
Paul Miller, M.D., director of the Colorado Center for Bone Research in Lakewood, recommended performing a vertebral assessment in patients with any of the following:
▸ Loss of 1.5 inches or more in height.
▸ Back pain in patients coming to your office for osteoporosis assessment.
▸ Known vertebral deformities or hip fractures.
▸ Kyphosis.
▸ Chronic glucocorticoid therapy.
▸ Age older than 60 years.
Turnover Markers
There are a number of potential advantages to using bone turnover markers, according to Douglas C. Bauer, M.D., of the University of California, San Francisco.
These measurements provide a more dynamic assessment of skeletal metabolism than BMD. More importantly, bone turnover markers rapidly reflect changes as a result of therapy, providing a better means of assessing treatment efficacy.
The most significant disadvantage to using clinical markers is that there is typically very high day-to-day and even time-of-day variability in the results, Dr. Bauer said.
Timing
For a patient who has been on an antiresorptive therapy and who will be taking teriparatide, there is no need for a break between the two therapies, said John Bilezikian, M.D., professor of medicine and pharmacology at Columbia University, New York.
For patients starting therapy for low BMD, Dr. Bilezikian recommends monotherapy with either an antiresorptive or with parathyroid hormone.
NEW ORLEANS — Bone health experts offered their share of helpful clinical insights at the annual meeting of the International Society for Clinical Densitometry.
Here are some of the highlights:
Low Bone Density in the Young
Low bone density is not uncommon in young adults but—at least in the short term—does not carry with it the same relative risk of fracture as in older individuals unless secondary causes of metabolic bone disease are identified, said Andrew J. Laster, M.D., a rheumatologist practicing in North Carolina.
Secondary causes of low BMD include endocrinopathies (hypercalciuria, hypogonadism, hyperparathyroidism, and Cushing's syndrome), some GI disorders (gastrectomy, inflammatory bowel disease, celiac disease, intestinal bypass surgery, primary biliary cirrhosis, and pancreatic insufficiency), genetic disorders (Ehlers-Danlos syndrome, Marfan syndrome, and homocystinuria), and eating disorders (anorexia nervosa, bulimia nervosa, and female athlete triad).
Assessing Fracture Risk Factors
Before experts declare the benefits of addressing a particular risk factor in an individual patient, they should stop and ask some key questions, advised John Kanis, M.D., director of the World Health Organization's Collaborating Centre for Metabolic Bone Diseases in Sheffield, England.
The questions are: Is the risk factor internationally validated? Is it feasible for a primary care physician to assess the risk factor? Is the risk factor intuitive?
When to Do Vertebral Assessments
Paul Miller, M.D., director of the Colorado Center for Bone Research in Lakewood, recommended performing a vertebral assessment in patients with any of the following:
▸ Loss of 1.5 inches or more in height.
▸ Back pain in patients coming to your office for osteoporosis assessment.
▸ Known vertebral deformities or hip fractures.
▸ Kyphosis.
▸ Chronic glucocorticoid therapy.
▸ Age older than 60 years.
Turnover Markers
There are a number of potential advantages to using bone turnover markers, according to Douglas C. Bauer, M.D., of the University of California, San Francisco.
These measurements provide a more dynamic assessment of skeletal metabolism than BMD. More importantly, bone turnover markers rapidly reflect changes as a result of therapy, providing a better means of assessing treatment efficacy.
The most significant disadvantage to using clinical markers is that there is typically very high day-to-day and even time-of-day variability in the results, Dr. Bauer said.
Timing
For a patient who has been on an antiresorptive therapy and who will be taking teriparatide, there is no need for a break between the two therapies, said John Bilezikian, M.D., professor of medicine and pharmacology at Columbia University, New York.
For patients starting therapy for low BMD, Dr. Bilezikian recommends monotherapy with either an antiresorptive or with parathyroid hormone.
NEW ORLEANS — Bone health experts offered their share of helpful clinical insights at the annual meeting of the International Society for Clinical Densitometry.
Here are some of the highlights:
Low Bone Density in the Young
Low bone density is not uncommon in young adults but—at least in the short term—does not carry with it the same relative risk of fracture as in older individuals unless secondary causes of metabolic bone disease are identified, said Andrew J. Laster, M.D., a rheumatologist practicing in North Carolina.
Secondary causes of low BMD include endocrinopathies (hypercalciuria, hypogonadism, hyperparathyroidism, and Cushing's syndrome), some GI disorders (gastrectomy, inflammatory bowel disease, celiac disease, intestinal bypass surgery, primary biliary cirrhosis, and pancreatic insufficiency), genetic disorders (Ehlers-Danlos syndrome, Marfan syndrome, and homocystinuria), and eating disorders (anorexia nervosa, bulimia nervosa, and female athlete triad).
Assessing Fracture Risk Factors
Before experts declare the benefits of addressing a particular risk factor in an individual patient, they should stop and ask some key questions, advised John Kanis, M.D., director of the World Health Organization's Collaborating Centre for Metabolic Bone Diseases in Sheffield, England.
The questions are: Is the risk factor internationally validated? Is it feasible for a primary care physician to assess the risk factor? Is the risk factor intuitive?
When to Do Vertebral Assessments
Paul Miller, M.D., director of the Colorado Center for Bone Research in Lakewood, recommended performing a vertebral assessment in patients with any of the following:
▸ Loss of 1.5 inches or more in height.
▸ Back pain in patients coming to your office for osteoporosis assessment.
▸ Known vertebral deformities or hip fractures.
▸ Kyphosis.
▸ Chronic glucocorticoid therapy.
▸ Age older than 60 years.
Turnover Markers
There are a number of potential advantages to using bone turnover markers, according to Douglas C. Bauer, M.D., of the University of California, San Francisco.
These measurements provide a more dynamic assessment of skeletal metabolism than BMD. More importantly, bone turnover markers rapidly reflect changes as a result of therapy, providing a better means of assessing treatment efficacy.
The most significant disadvantage to using clinical markers is that there is typically very high day-to-day and even time-of-day variability in the results, Dr. Bauer said.
Timing
For a patient who has been on an antiresorptive therapy and who will be taking teriparatide, there is no need for a break between the two therapies, said John Bilezikian, M.D., professor of medicine and pharmacology at Columbia University, New York.
For patients starting therapy for low BMD, Dr. Bilezikian recommends monotherapy with either an antiresorptive or with parathyroid hormone.
Biomarkers, Architecture Assessment on Horizon
NEW ORLEANS — Of all the factors that contribute to bone strength, the rate of turnover may be most clinically relevant, David Dempster, Ph.D., said at the annual meeting of the International Society for Clinical Densitometry.
At the same time, several recent advances may soon transform the way bone is assessed.
Bone turnover affects each and every one of the other variables that factor into bone strength, including structural factors and material properties, said Dr. Dempster, professor of clinical pathology at Columbia University, New York.
High bone turnover increases remodeling space, accelerates bone loss, disrupts the trabecular microarchitecture, increases mechanical stress concentration, decreases mineralization density, and increases cortical porosity, each of which can undermine bone strength, Dr. Dempster said.
When osteoclast activity exceeds osteoblast activity, there's a deficit on the surface of the trabeculae and within the cortex. “This may not amount to much in terms of bone mass … but I think that a small amount of missing bone may be important.”
As bone mass declines, there is an exponential increase in fracture risk. “Simply by preventing a small amount of bone loss, you will prevent that patient from going up a steep slope in terms of fracture risk,” he said.
Another consequence of high turnover is the increase in the destruction of the trabecular microarchitecture. As bone turnover increases, there is a preferential loss of the horizontal trabeculae known as cross-ties, said Dr. Dempster.
“I'm talking about high turnover in a catabolic sense … where resorption exceeds formation.” This type of turnover occurs shortly after menopause or shortly after the introduction of glucocorticoids, said Dr. Dempster, who is also the director of the Regional Bone Center at the Helen Hayes Hospital in West Haverstraw, N.Y.
After menopause, a confluence of three phenomena can occur: a greater number of osteoclasts gather on the bone surface, osteoclasts become more efficient at breaking bone down, and the plates may become thinner. The result is that instead of sweeping across the trabecular surface—as with normal bone turnover—the osteoclasts tend to penetrate through the trabecular plate, leaving osteoblasts without a template for creating new bone. Supportive horizontal trabecular rods eventually become disconnected.
Mechanical stress concentration is another important element of bone strength. Osteoclast resorption cavities are the mechanical stress points. Without these cavities, intact trabeculae bend in response to stress but don't break. When resorption cavities are present, the same force will cause the trabeculae to break.
With high bone turnover, mineral density declines. While measuring bone mineral density (BMD) captures large-scale information on mineralization density, it doesn't provide information on the local distribution of minerals.
Nor do conventional BMD measures provide information on the collagen-to-mineral ratio. Too much mineral makes bones brittle; too much collagen makes them weak.
So far, markers of bone turnover have been shown to be useful in the research setting, by they aren't ready for clinical use, said Dr. Dempster. Still, once they are ready, “I think that a BMD test coupled with a good measure of bone turnover in an individual patient would give you much more information than you currently have.”
Improvements to turnover measurement are imminent, as more of these tests are incorporated into auto-analyzer formats. In addition, progress is being made in defining what the normal premenopausal range is for these markers.
“We [also] have some very good research going on looking at how we can assess microarchitecture noninvasively,” he said. Quantitative CT is starting to be used to assess bone strength in hip structural analysis.
These newer techniques help measure not only BMD but also help assesses the structural geometry of cross sections at specific locations of the hip. The evaluation of bone microarchitecture has benefited from the use of technologies such as peripheral quantitative CT and high-resolution micro MRI.
In the past, bone microarchitecture has been hampered by the need to extract bone samples from volunteers and look at these samples under a powerful microscope. These new technologies give researchers an easier way to study a larger pool of volunteers.
NEW ORLEANS — Of all the factors that contribute to bone strength, the rate of turnover may be most clinically relevant, David Dempster, Ph.D., said at the annual meeting of the International Society for Clinical Densitometry.
At the same time, several recent advances may soon transform the way bone is assessed.
Bone turnover affects each and every one of the other variables that factor into bone strength, including structural factors and material properties, said Dr. Dempster, professor of clinical pathology at Columbia University, New York.
High bone turnover increases remodeling space, accelerates bone loss, disrupts the trabecular microarchitecture, increases mechanical stress concentration, decreases mineralization density, and increases cortical porosity, each of which can undermine bone strength, Dr. Dempster said.
When osteoclast activity exceeds osteoblast activity, there's a deficit on the surface of the trabeculae and within the cortex. “This may not amount to much in terms of bone mass … but I think that a small amount of missing bone may be important.”
As bone mass declines, there is an exponential increase in fracture risk. “Simply by preventing a small amount of bone loss, you will prevent that patient from going up a steep slope in terms of fracture risk,” he said.
Another consequence of high turnover is the increase in the destruction of the trabecular microarchitecture. As bone turnover increases, there is a preferential loss of the horizontal trabeculae known as cross-ties, said Dr. Dempster.
“I'm talking about high turnover in a catabolic sense … where resorption exceeds formation.” This type of turnover occurs shortly after menopause or shortly after the introduction of glucocorticoids, said Dr. Dempster, who is also the director of the Regional Bone Center at the Helen Hayes Hospital in West Haverstraw, N.Y.
After menopause, a confluence of three phenomena can occur: a greater number of osteoclasts gather on the bone surface, osteoclasts become more efficient at breaking bone down, and the plates may become thinner. The result is that instead of sweeping across the trabecular surface—as with normal bone turnover—the osteoclasts tend to penetrate through the trabecular plate, leaving osteoblasts without a template for creating new bone. Supportive horizontal trabecular rods eventually become disconnected.
Mechanical stress concentration is another important element of bone strength. Osteoclast resorption cavities are the mechanical stress points. Without these cavities, intact trabeculae bend in response to stress but don't break. When resorption cavities are present, the same force will cause the trabeculae to break.
With high bone turnover, mineral density declines. While measuring bone mineral density (BMD) captures large-scale information on mineralization density, it doesn't provide information on the local distribution of minerals.
Nor do conventional BMD measures provide information on the collagen-to-mineral ratio. Too much mineral makes bones brittle; too much collagen makes them weak.
So far, markers of bone turnover have been shown to be useful in the research setting, by they aren't ready for clinical use, said Dr. Dempster. Still, once they are ready, “I think that a BMD test coupled with a good measure of bone turnover in an individual patient would give you much more information than you currently have.”
Improvements to turnover measurement are imminent, as more of these tests are incorporated into auto-analyzer formats. In addition, progress is being made in defining what the normal premenopausal range is for these markers.
“We [also] have some very good research going on looking at how we can assess microarchitecture noninvasively,” he said. Quantitative CT is starting to be used to assess bone strength in hip structural analysis.
These newer techniques help measure not only BMD but also help assesses the structural geometry of cross sections at specific locations of the hip. The evaluation of bone microarchitecture has benefited from the use of technologies such as peripheral quantitative CT and high-resolution micro MRI.
In the past, bone microarchitecture has been hampered by the need to extract bone samples from volunteers and look at these samples under a powerful microscope. These new technologies give researchers an easier way to study a larger pool of volunteers.
NEW ORLEANS — Of all the factors that contribute to bone strength, the rate of turnover may be most clinically relevant, David Dempster, Ph.D., said at the annual meeting of the International Society for Clinical Densitometry.
At the same time, several recent advances may soon transform the way bone is assessed.
Bone turnover affects each and every one of the other variables that factor into bone strength, including structural factors and material properties, said Dr. Dempster, professor of clinical pathology at Columbia University, New York.
High bone turnover increases remodeling space, accelerates bone loss, disrupts the trabecular microarchitecture, increases mechanical stress concentration, decreases mineralization density, and increases cortical porosity, each of which can undermine bone strength, Dr. Dempster said.
When osteoclast activity exceeds osteoblast activity, there's a deficit on the surface of the trabeculae and within the cortex. “This may not amount to much in terms of bone mass … but I think that a small amount of missing bone may be important.”
As bone mass declines, there is an exponential increase in fracture risk. “Simply by preventing a small amount of bone loss, you will prevent that patient from going up a steep slope in terms of fracture risk,” he said.
Another consequence of high turnover is the increase in the destruction of the trabecular microarchitecture. As bone turnover increases, there is a preferential loss of the horizontal trabeculae known as cross-ties, said Dr. Dempster.
“I'm talking about high turnover in a catabolic sense … where resorption exceeds formation.” This type of turnover occurs shortly after menopause or shortly after the introduction of glucocorticoids, said Dr. Dempster, who is also the director of the Regional Bone Center at the Helen Hayes Hospital in West Haverstraw, N.Y.
After menopause, a confluence of three phenomena can occur: a greater number of osteoclasts gather on the bone surface, osteoclasts become more efficient at breaking bone down, and the plates may become thinner. The result is that instead of sweeping across the trabecular surface—as with normal bone turnover—the osteoclasts tend to penetrate through the trabecular plate, leaving osteoblasts without a template for creating new bone. Supportive horizontal trabecular rods eventually become disconnected.
Mechanical stress concentration is another important element of bone strength. Osteoclast resorption cavities are the mechanical stress points. Without these cavities, intact trabeculae bend in response to stress but don't break. When resorption cavities are present, the same force will cause the trabeculae to break.
With high bone turnover, mineral density declines. While measuring bone mineral density (BMD) captures large-scale information on mineralization density, it doesn't provide information on the local distribution of minerals.
Nor do conventional BMD measures provide information on the collagen-to-mineral ratio. Too much mineral makes bones brittle; too much collagen makes them weak.
So far, markers of bone turnover have been shown to be useful in the research setting, by they aren't ready for clinical use, said Dr. Dempster. Still, once they are ready, “I think that a BMD test coupled with a good measure of bone turnover in an individual patient would give you much more information than you currently have.”
Improvements to turnover measurement are imminent, as more of these tests are incorporated into auto-analyzer formats. In addition, progress is being made in defining what the normal premenopausal range is for these markers.
“We [also] have some very good research going on looking at how we can assess microarchitecture noninvasively,” he said. Quantitative CT is starting to be used to assess bone strength in hip structural analysis.
These newer techniques help measure not only BMD but also help assesses the structural geometry of cross sections at specific locations of the hip. The evaluation of bone microarchitecture has benefited from the use of technologies such as peripheral quantitative CT and high-resolution micro MRI.
In the past, bone microarchitecture has been hampered by the need to extract bone samples from volunteers and look at these samples under a powerful microscope. These new technologies give researchers an easier way to study a larger pool of volunteers.
Tell Patients: Bisphosphonates Work, but Not in the Bottle
WASHINGTON — Postmenopausal women with osteoporosis can reduce their risk for fractures by 26% if they stick to their bisphosphonate regimens, Ethel Siris, M.D., reported in a poster presented at an international symposium sponsored by the National Osteoporosis Foundation.
However, that “if” is a very big one, said Dr. S. Siris, director of the metabolic bone diseases program at Columbia University Medical Center, New York.
In a retrospective study of 6,285 women, 48% were compliant in terms of refilling their prescriptions, and 21% were persistent in terms of staying on the medication beyond the 2-year follow-up.
Overall, the relative risk of fracture over a 2-year period was 26% lower among refill-compliant women vs. noncompliant women (9.4% vs. 12.6%) and 21% lower among treatment persistent women vs. nonpersistent women (9.1% vs. 11.6%).
More than half (52%) of the women were noncompliant, based on insufficient refills, and approximately 21% were nonpersistent, defined as having a discontinuation of therapy within the 2-year period.
Data on the pharmaceutical claims of women aged 45 years and older who met the criteria for postmenopausal osteoporosis were taken from the Medstat MarketScan Research Database. The women had received at least one prescription for a bisphosphonate; 85% received alendronate (Fosamax) and 15% received risedronate (Actonel).
Although bisphosphonates are a popular choice for fracture risk reduction in osteoporotic women, their effectiveness depends on compliance for an extended period of time. And compliance is notoriously poor.
“If we actually get people to take these drugs, we might cut as many as 400,000 fractures in a given year,” Dr. Siris said. Studies on less frequent dosing regimens, such as the once-monthly regimen for the newly approved ibandronate (Boniva), suggest they are effective and may improve compliance.
Dr. Siris is a consultant for and has received honoraria from Eli Lilly & Co., Merck & Co., Sanofi Aventis, Procter & Gamble Pharmaceuticals, and Novartis.
WASHINGTON — Postmenopausal women with osteoporosis can reduce their risk for fractures by 26% if they stick to their bisphosphonate regimens, Ethel Siris, M.D., reported in a poster presented at an international symposium sponsored by the National Osteoporosis Foundation.
However, that “if” is a very big one, said Dr. S. Siris, director of the metabolic bone diseases program at Columbia University Medical Center, New York.
In a retrospective study of 6,285 women, 48% were compliant in terms of refilling their prescriptions, and 21% were persistent in terms of staying on the medication beyond the 2-year follow-up.
Overall, the relative risk of fracture over a 2-year period was 26% lower among refill-compliant women vs. noncompliant women (9.4% vs. 12.6%) and 21% lower among treatment persistent women vs. nonpersistent women (9.1% vs. 11.6%).
More than half (52%) of the women were noncompliant, based on insufficient refills, and approximately 21% were nonpersistent, defined as having a discontinuation of therapy within the 2-year period.
Data on the pharmaceutical claims of women aged 45 years and older who met the criteria for postmenopausal osteoporosis were taken from the Medstat MarketScan Research Database. The women had received at least one prescription for a bisphosphonate; 85% received alendronate (Fosamax) and 15% received risedronate (Actonel).
Although bisphosphonates are a popular choice for fracture risk reduction in osteoporotic women, their effectiveness depends on compliance for an extended period of time. And compliance is notoriously poor.
“If we actually get people to take these drugs, we might cut as many as 400,000 fractures in a given year,” Dr. Siris said. Studies on less frequent dosing regimens, such as the once-monthly regimen for the newly approved ibandronate (Boniva), suggest they are effective and may improve compliance.
Dr. Siris is a consultant for and has received honoraria from Eli Lilly & Co., Merck & Co., Sanofi Aventis, Procter & Gamble Pharmaceuticals, and Novartis.
WASHINGTON — Postmenopausal women with osteoporosis can reduce their risk for fractures by 26% if they stick to their bisphosphonate regimens, Ethel Siris, M.D., reported in a poster presented at an international symposium sponsored by the National Osteoporosis Foundation.
However, that “if” is a very big one, said Dr. S. Siris, director of the metabolic bone diseases program at Columbia University Medical Center, New York.
In a retrospective study of 6,285 women, 48% were compliant in terms of refilling their prescriptions, and 21% were persistent in terms of staying on the medication beyond the 2-year follow-up.
Overall, the relative risk of fracture over a 2-year period was 26% lower among refill-compliant women vs. noncompliant women (9.4% vs. 12.6%) and 21% lower among treatment persistent women vs. nonpersistent women (9.1% vs. 11.6%).
More than half (52%) of the women were noncompliant, based on insufficient refills, and approximately 21% were nonpersistent, defined as having a discontinuation of therapy within the 2-year period.
Data on the pharmaceutical claims of women aged 45 years and older who met the criteria for postmenopausal osteoporosis were taken from the Medstat MarketScan Research Database. The women had received at least one prescription for a bisphosphonate; 85% received alendronate (Fosamax) and 15% received risedronate (Actonel).
Although bisphosphonates are a popular choice for fracture risk reduction in osteoporotic women, their effectiveness depends on compliance for an extended period of time. And compliance is notoriously poor.
“If we actually get people to take these drugs, we might cut as many as 400,000 fractures in a given year,” Dr. Siris said. Studies on less frequent dosing regimens, such as the once-monthly regimen for the newly approved ibandronate (Boniva), suggest they are effective and may improve compliance.
Dr. Siris is a consultant for and has received honoraria from Eli Lilly & Co., Merck & Co., Sanofi Aventis, Procter & Gamble Pharmaceuticals, and Novartis.
Monthly Ibandronate Rivals Daily Dose
WASHINGTON — A monthly dose of oral ibandronate is at least as safe and as effective at increasing bone mineral density as a daily dose, according to data from a study of more than 1,200 postmenopausal women with osteoporosis.
The Monthly Oral Ibandronate in Ladies (MOBILE) study, a multinational randomized, double-blind, phase III study of women aged 55-80 years, will continue for 2 years, Michael Bolognese, M.D., said in a poster presented at an international symposium sponsored by the National Osteoporosis Foundation. Dr. Bolognese and his colleagues presented their 1-year results at the meeting.
A total of 318 women received a 2.5-mg dose of oral ibandronate (Boniva) daily; another 328 women received a 50/50 mg dose (two 50-mg single doses on 2 consecutive days) monthly; 311 received one 100-mg dose monthly; and 320 received one 150-mg dose monthly.
At 1 year, the increase in BMD at the lumbar spine was 3.9% in the daily group, compared with 4.3%, 4.1%, and 4.9% in the groups receiving 50/50 mg, 100 mg, and 150 mg monthly.
Increases in the total hip BMD were 2.2% in the daily group, compared with 2.2%, 2.7%, and 3.1% in the 50/50 mg, and monthly groups. Similar increases occurred at the femoral neck and hip trochanter. All treatment also groups had significant decreases in serum CTX, a bone resorption marker. The 150-mg group showed the most robust response.
The dosage of the newly approved monthly formulation of ibandronate (Boniva) is 150 mg; it has been shown to have maximal effectiveness when taken 60 minutes before eating, said Dr. Bolognese, of Bethesda (Md.) Health Research.
The incidence of adverse events and withdrawal rates were comparable across treatment groups. About 70%-80% of the adverse events were gastrointestinal, but the incidence was relatively low and comparable across all treatment groups. In fact, the rate of discontinuation due to upper GI events was lower among patients in the 150-mg group (3.3%), 100-mg group (4.0%), and 50/50-mg group (4.0%) vs. the daily group (5.3%).
Dr. Bolognese is a consultant for Eli Lilly & Co. and Proctor & Gamble, and he has received grants or research support from Sanofi-Aventis, Pfizer, Lilly, and Wyeth Pharmaceuticals.
WASHINGTON — A monthly dose of oral ibandronate is at least as safe and as effective at increasing bone mineral density as a daily dose, according to data from a study of more than 1,200 postmenopausal women with osteoporosis.
The Monthly Oral Ibandronate in Ladies (MOBILE) study, a multinational randomized, double-blind, phase III study of women aged 55-80 years, will continue for 2 years, Michael Bolognese, M.D., said in a poster presented at an international symposium sponsored by the National Osteoporosis Foundation. Dr. Bolognese and his colleagues presented their 1-year results at the meeting.
A total of 318 women received a 2.5-mg dose of oral ibandronate (Boniva) daily; another 328 women received a 50/50 mg dose (two 50-mg single doses on 2 consecutive days) monthly; 311 received one 100-mg dose monthly; and 320 received one 150-mg dose monthly.
At 1 year, the increase in BMD at the lumbar spine was 3.9% in the daily group, compared with 4.3%, 4.1%, and 4.9% in the groups receiving 50/50 mg, 100 mg, and 150 mg monthly.
Increases in the total hip BMD were 2.2% in the daily group, compared with 2.2%, 2.7%, and 3.1% in the 50/50 mg, and monthly groups. Similar increases occurred at the femoral neck and hip trochanter. All treatment also groups had significant decreases in serum CTX, a bone resorption marker. The 150-mg group showed the most robust response.
The dosage of the newly approved monthly formulation of ibandronate (Boniva) is 150 mg; it has been shown to have maximal effectiveness when taken 60 minutes before eating, said Dr. Bolognese, of Bethesda (Md.) Health Research.
The incidence of adverse events and withdrawal rates were comparable across treatment groups. About 70%-80% of the adverse events were gastrointestinal, but the incidence was relatively low and comparable across all treatment groups. In fact, the rate of discontinuation due to upper GI events was lower among patients in the 150-mg group (3.3%), 100-mg group (4.0%), and 50/50-mg group (4.0%) vs. the daily group (5.3%).
Dr. Bolognese is a consultant for Eli Lilly & Co. and Proctor & Gamble, and he has received grants or research support from Sanofi-Aventis, Pfizer, Lilly, and Wyeth Pharmaceuticals.
WASHINGTON — A monthly dose of oral ibandronate is at least as safe and as effective at increasing bone mineral density as a daily dose, according to data from a study of more than 1,200 postmenopausal women with osteoporosis.
The Monthly Oral Ibandronate in Ladies (MOBILE) study, a multinational randomized, double-blind, phase III study of women aged 55-80 years, will continue for 2 years, Michael Bolognese, M.D., said in a poster presented at an international symposium sponsored by the National Osteoporosis Foundation. Dr. Bolognese and his colleagues presented their 1-year results at the meeting.
A total of 318 women received a 2.5-mg dose of oral ibandronate (Boniva) daily; another 328 women received a 50/50 mg dose (two 50-mg single doses on 2 consecutive days) monthly; 311 received one 100-mg dose monthly; and 320 received one 150-mg dose monthly.
At 1 year, the increase in BMD at the lumbar spine was 3.9% in the daily group, compared with 4.3%, 4.1%, and 4.9% in the groups receiving 50/50 mg, 100 mg, and 150 mg monthly.
Increases in the total hip BMD were 2.2% in the daily group, compared with 2.2%, 2.7%, and 3.1% in the 50/50 mg, and monthly groups. Similar increases occurred at the femoral neck and hip trochanter. All treatment also groups had significant decreases in serum CTX, a bone resorption marker. The 150-mg group showed the most robust response.
The dosage of the newly approved monthly formulation of ibandronate (Boniva) is 150 mg; it has been shown to have maximal effectiveness when taken 60 minutes before eating, said Dr. Bolognese, of Bethesda (Md.) Health Research.
The incidence of adverse events and withdrawal rates were comparable across treatment groups. About 70%-80% of the adverse events were gastrointestinal, but the incidence was relatively low and comparable across all treatment groups. In fact, the rate of discontinuation due to upper GI events was lower among patients in the 150-mg group (3.3%), 100-mg group (4.0%), and 50/50-mg group (4.0%) vs. the daily group (5.3%).
Dr. Bolognese is a consultant for Eli Lilly & Co. and Proctor & Gamble, and he has received grants or research support from Sanofi-Aventis, Pfizer, Lilly, and Wyeth Pharmaceuticals.
Counsel Patients on Nutrition to Prevent Fractures
NEW ORLEANS — With a virtual alphabet soup of vitamin and mineral supplements available—and a constant barrage of new nutritional advice each week—it's a challenge to know what truly bolsters bone health, Neil Binkley, M.D., declared at the annual meeting of the International Society for Clinical Densitometry.
General malnutrition is actually a common phenomenon in the United States, said Dr. Binkley, of the Institute on Aging at the University of Wisconsin in Madison. According to one study, 11% of patients older than 65 are undernourished. And studies have suggested that elderly patients with fractures are more likely to be malnourished. Dr. Binkley shared the following tips about diet and nutrition:
Phosphorus
Phosphorus insufficiency is generally not a common problem; however, it tends to occur in some of the more vulnerable populations. Phosphorus deficiency decreases mineralization and osteoblast function while increasing osteoclast function. An estimated 15% of women over age 80 receive less than 70% of the U.S. recommended daily allowance (RDA) of phosphorus (1,000 mg). It's also been suggested that patients who fail to respond to calcium supplementation may, in fact, have inadequate phosphorus intake.
Vitamin D
Make sure patients are aware that not all dairy products are fortified with vitamin D. “You can't get vitamin D in food unless you happen to like liver or lots of salmon or mackerel,” Dr. Binkley said.
Vitamin D toxicity is less of a concern than it once was. Recommended levels of vitamin D range from 1,200 to 1,500 IU per day. Levels in excess of 10,000 IU per day are now believed toxic, so there is a large margin of error.
Supplements may be necessary to get enough vitamin D. Dr. Binkley noted that to get 1,000 IU vitamin D, you would need to drink half a gallon of milk or eat 40 egg yolks. Getting a little sun is also an option.
The bigger problem with ensuring that patients get enough vitamin D may be in obtaining a good assay, said Dr. Binkley. In one study, he and his colleagues used four different assays to measure patient vitamin D levels. Although the four methods agreed quite well for some patients, there were big differences among the assays for other patients.
Attempts to standardize vitamin D assays are ongoing. High-performance liquid chromatography (HPLC) appears to provide the best results. Dr. Binkley advised that if HPLC and commercial assays agree that a patient's vitamin D levels are low, they probably are. But if commercial assays indicate a patient's levels are not low, consider HPLC. He also noted that if you give your patient very high, prescription-level doses (50,000 IU) of vitamin D, at least one of the commercial 25-hydroxy assays only detects about half of it in the blood.
Vitamin A
A family of about 25 compounds constitute vitamin A, but the active component is retinol. The RDA for vitamin A is 2,600 IU (800 mcg) per day for men and 2,300 IU (700 mcg) per day for women.
The effects of getting too much vitamin A are unclear. Generally, it's been assumed that the body has built-in safeguards to avoid vitamin A toxicity. If one eats 6 pounds of carotenoids (retinol precursors), the body makes only 1 pound of retinol.
Yet it's theorized that excessive vitamin A will suppress osteoblast activity and stimulate bone reabsorption. In addition, epidemiologic data suggest the consumption of more than 5,000 IU daily increases fracture risk—but clinical studies have not confirmed this association.
Dietary sources of vitamin A include liver, fish, and fortified foods such as dairy products; certain fruits and vegetables are high in carotenoids. Vitamin A supplementation is considered necessary only in special situations, and patients should be counseled never to take synthetic retinol.
Vitamin K
Low vitamin K levels have been reported in patients with osteoporotic fractures and epidemiologic data show an increased risk of hip fracture with low levels of vitamin K. However, vitamin K doesn't linger in the blood for very long, so it's difficult to get an accurate measure, said Dr. Binkley.
Most of the existing data come from Japan, where a different form of vitamin K is taken from that used in the United States. The Japanese studies used 45 mg per day and showed sustained levels of bone mineral density (BMD) and vertebral fracture-prevention benefits. Adequate intake of vitamin K in the United States, however, is thought to be about 100 mcg per day. It's probably too early to recommend vitamin K supplementation, he concluded.
Magnesium
Inadequate magnesium is associated with decreased parathyroid hormone. Epidemiologic studies suggest a positive association between increased magnesium intake and BMD. But data from the Women's Health Initiative found that high magnesium intake was not protective of BMD. The bottom line for patients is to eat foods that contain magnesium, including whole grains, vegetables, and nuts. There are no data to support the use of magnesium supplements, Dr. Binkley said.
Caffeine
It's been widely assumed that caffeine is harmful to bone because it leads to increased urinary calcium loss. However, a number of studies have shown that decreased calcium absorption is actually what occurs. “The gist is that for each cup of coffee that we drink, there is a calcium loss of about 5 mg. What does that mean? It means that we need to put about 2 tablespoons of milk in our coffee,” said Dr. Binkley.
The effect of these other caffeinated beverages on calcium absorption is largely negligible. The bigger issue is that soft drinks have replaced milk in the average American's diet.
Protein
One study of elderly patients found that patients getting protein supplements were less likely to have fractures.
In fact, those with higher protein intake and adequate calcium had the best outcomes, suggesting there may be a synergistic effect between protein and calcium. There's no need to restrict protein after hip fractures.
NEW ORLEANS — With a virtual alphabet soup of vitamin and mineral supplements available—and a constant barrage of new nutritional advice each week—it's a challenge to know what truly bolsters bone health, Neil Binkley, M.D., declared at the annual meeting of the International Society for Clinical Densitometry.
General malnutrition is actually a common phenomenon in the United States, said Dr. Binkley, of the Institute on Aging at the University of Wisconsin in Madison. According to one study, 11% of patients older than 65 are undernourished. And studies have suggested that elderly patients with fractures are more likely to be malnourished. Dr. Binkley shared the following tips about diet and nutrition:
Phosphorus
Phosphorus insufficiency is generally not a common problem; however, it tends to occur in some of the more vulnerable populations. Phosphorus deficiency decreases mineralization and osteoblast function while increasing osteoclast function. An estimated 15% of women over age 80 receive less than 70% of the U.S. recommended daily allowance (RDA) of phosphorus (1,000 mg). It's also been suggested that patients who fail to respond to calcium supplementation may, in fact, have inadequate phosphorus intake.
Vitamin D
Make sure patients are aware that not all dairy products are fortified with vitamin D. “You can't get vitamin D in food unless you happen to like liver or lots of salmon or mackerel,” Dr. Binkley said.
Vitamin D toxicity is less of a concern than it once was. Recommended levels of vitamin D range from 1,200 to 1,500 IU per day. Levels in excess of 10,000 IU per day are now believed toxic, so there is a large margin of error.
Supplements may be necessary to get enough vitamin D. Dr. Binkley noted that to get 1,000 IU vitamin D, you would need to drink half a gallon of milk or eat 40 egg yolks. Getting a little sun is also an option.
The bigger problem with ensuring that patients get enough vitamin D may be in obtaining a good assay, said Dr. Binkley. In one study, he and his colleagues used four different assays to measure patient vitamin D levels. Although the four methods agreed quite well for some patients, there were big differences among the assays for other patients.
Attempts to standardize vitamin D assays are ongoing. High-performance liquid chromatography (HPLC) appears to provide the best results. Dr. Binkley advised that if HPLC and commercial assays agree that a patient's vitamin D levels are low, they probably are. But if commercial assays indicate a patient's levels are not low, consider HPLC. He also noted that if you give your patient very high, prescription-level doses (50,000 IU) of vitamin D, at least one of the commercial 25-hydroxy assays only detects about half of it in the blood.
Vitamin A
A family of about 25 compounds constitute vitamin A, but the active component is retinol. The RDA for vitamin A is 2,600 IU (800 mcg) per day for men and 2,300 IU (700 mcg) per day for women.
The effects of getting too much vitamin A are unclear. Generally, it's been assumed that the body has built-in safeguards to avoid vitamin A toxicity. If one eats 6 pounds of carotenoids (retinol precursors), the body makes only 1 pound of retinol.
Yet it's theorized that excessive vitamin A will suppress osteoblast activity and stimulate bone reabsorption. In addition, epidemiologic data suggest the consumption of more than 5,000 IU daily increases fracture risk—but clinical studies have not confirmed this association.
Dietary sources of vitamin A include liver, fish, and fortified foods such as dairy products; certain fruits and vegetables are high in carotenoids. Vitamin A supplementation is considered necessary only in special situations, and patients should be counseled never to take synthetic retinol.
Vitamin K
Low vitamin K levels have been reported in patients with osteoporotic fractures and epidemiologic data show an increased risk of hip fracture with low levels of vitamin K. However, vitamin K doesn't linger in the blood for very long, so it's difficult to get an accurate measure, said Dr. Binkley.
Most of the existing data come from Japan, where a different form of vitamin K is taken from that used in the United States. The Japanese studies used 45 mg per day and showed sustained levels of bone mineral density (BMD) and vertebral fracture-prevention benefits. Adequate intake of vitamin K in the United States, however, is thought to be about 100 mcg per day. It's probably too early to recommend vitamin K supplementation, he concluded.
Magnesium
Inadequate magnesium is associated with decreased parathyroid hormone. Epidemiologic studies suggest a positive association between increased magnesium intake and BMD. But data from the Women's Health Initiative found that high magnesium intake was not protective of BMD. The bottom line for patients is to eat foods that contain magnesium, including whole grains, vegetables, and nuts. There are no data to support the use of magnesium supplements, Dr. Binkley said.
Caffeine
It's been widely assumed that caffeine is harmful to bone because it leads to increased urinary calcium loss. However, a number of studies have shown that decreased calcium absorption is actually what occurs. “The gist is that for each cup of coffee that we drink, there is a calcium loss of about 5 mg. What does that mean? It means that we need to put about 2 tablespoons of milk in our coffee,” said Dr. Binkley.
The effect of these other caffeinated beverages on calcium absorption is largely negligible. The bigger issue is that soft drinks have replaced milk in the average American's diet.
Protein
One study of elderly patients found that patients getting protein supplements were less likely to have fractures.
In fact, those with higher protein intake and adequate calcium had the best outcomes, suggesting there may be a synergistic effect between protein and calcium. There's no need to restrict protein after hip fractures.
NEW ORLEANS — With a virtual alphabet soup of vitamin and mineral supplements available—and a constant barrage of new nutritional advice each week—it's a challenge to know what truly bolsters bone health, Neil Binkley, M.D., declared at the annual meeting of the International Society for Clinical Densitometry.
General malnutrition is actually a common phenomenon in the United States, said Dr. Binkley, of the Institute on Aging at the University of Wisconsin in Madison. According to one study, 11% of patients older than 65 are undernourished. And studies have suggested that elderly patients with fractures are more likely to be malnourished. Dr. Binkley shared the following tips about diet and nutrition:
Phosphorus
Phosphorus insufficiency is generally not a common problem; however, it tends to occur in some of the more vulnerable populations. Phosphorus deficiency decreases mineralization and osteoblast function while increasing osteoclast function. An estimated 15% of women over age 80 receive less than 70% of the U.S. recommended daily allowance (RDA) of phosphorus (1,000 mg). It's also been suggested that patients who fail to respond to calcium supplementation may, in fact, have inadequate phosphorus intake.
Vitamin D
Make sure patients are aware that not all dairy products are fortified with vitamin D. “You can't get vitamin D in food unless you happen to like liver or lots of salmon or mackerel,” Dr. Binkley said.
Vitamin D toxicity is less of a concern than it once was. Recommended levels of vitamin D range from 1,200 to 1,500 IU per day. Levels in excess of 10,000 IU per day are now believed toxic, so there is a large margin of error.
Supplements may be necessary to get enough vitamin D. Dr. Binkley noted that to get 1,000 IU vitamin D, you would need to drink half a gallon of milk or eat 40 egg yolks. Getting a little sun is also an option.
The bigger problem with ensuring that patients get enough vitamin D may be in obtaining a good assay, said Dr. Binkley. In one study, he and his colleagues used four different assays to measure patient vitamin D levels. Although the four methods agreed quite well for some patients, there were big differences among the assays for other patients.
Attempts to standardize vitamin D assays are ongoing. High-performance liquid chromatography (HPLC) appears to provide the best results. Dr. Binkley advised that if HPLC and commercial assays agree that a patient's vitamin D levels are low, they probably are. But if commercial assays indicate a patient's levels are not low, consider HPLC. He also noted that if you give your patient very high, prescription-level doses (50,000 IU) of vitamin D, at least one of the commercial 25-hydroxy assays only detects about half of it in the blood.
Vitamin A
A family of about 25 compounds constitute vitamin A, but the active component is retinol. The RDA for vitamin A is 2,600 IU (800 mcg) per day for men and 2,300 IU (700 mcg) per day for women.
The effects of getting too much vitamin A are unclear. Generally, it's been assumed that the body has built-in safeguards to avoid vitamin A toxicity. If one eats 6 pounds of carotenoids (retinol precursors), the body makes only 1 pound of retinol.
Yet it's theorized that excessive vitamin A will suppress osteoblast activity and stimulate bone reabsorption. In addition, epidemiologic data suggest the consumption of more than 5,000 IU daily increases fracture risk—but clinical studies have not confirmed this association.
Dietary sources of vitamin A include liver, fish, and fortified foods such as dairy products; certain fruits and vegetables are high in carotenoids. Vitamin A supplementation is considered necessary only in special situations, and patients should be counseled never to take synthetic retinol.
Vitamin K
Low vitamin K levels have been reported in patients with osteoporotic fractures and epidemiologic data show an increased risk of hip fracture with low levels of vitamin K. However, vitamin K doesn't linger in the blood for very long, so it's difficult to get an accurate measure, said Dr. Binkley.
Most of the existing data come from Japan, where a different form of vitamin K is taken from that used in the United States. The Japanese studies used 45 mg per day and showed sustained levels of bone mineral density (BMD) and vertebral fracture-prevention benefits. Adequate intake of vitamin K in the United States, however, is thought to be about 100 mcg per day. It's probably too early to recommend vitamin K supplementation, he concluded.
Magnesium
Inadequate magnesium is associated with decreased parathyroid hormone. Epidemiologic studies suggest a positive association between increased magnesium intake and BMD. But data from the Women's Health Initiative found that high magnesium intake was not protective of BMD. The bottom line for patients is to eat foods that contain magnesium, including whole grains, vegetables, and nuts. There are no data to support the use of magnesium supplements, Dr. Binkley said.
Caffeine
It's been widely assumed that caffeine is harmful to bone because it leads to increased urinary calcium loss. However, a number of studies have shown that decreased calcium absorption is actually what occurs. “The gist is that for each cup of coffee that we drink, there is a calcium loss of about 5 mg. What does that mean? It means that we need to put about 2 tablespoons of milk in our coffee,” said Dr. Binkley.
The effect of these other caffeinated beverages on calcium absorption is largely negligible. The bigger issue is that soft drinks have replaced milk in the average American's diet.
Protein
One study of elderly patients found that patients getting protein supplements were less likely to have fractures.
In fact, those with higher protein intake and adequate calcium had the best outcomes, suggesting there may be a synergistic effect between protein and calcium. There's no need to restrict protein after hip fractures.
Intravenous Ibandronate Every Few MonthsMore Effective Than Oral Daily Dosing
WASHINGTON — Postmenopausal women with osteoporosis who can't tolerate oral ibandronate may welcome an intravenous option, Michael Bolognese, M.D., reported at an international symposium sponsored by the National Osteoporosis Foundation.
One-year results from the Dosing Intravenous Administration (DIVA) study, an ongoing randomized, double-blind, phase III trial, showed that rapid injections of ibandronate (Boniva) in amounts of 2 mg every 2 months or 3 mg every 3 months were more effective than the standard oral daily dose of 2.5 mg at increasing bone mineral density (BMD), Dr. Bolognese of Bethesda (Md.) Health Research and his colleagues wrote in a poster presentation of their findings.
The increases in the BMD at the lumbar spine were significantly greater for women on both the 2-mg/2 mo (5.1%) and 3-mg/3 mo (4.8%) regimens compared with the 2.5-mg daily oral dosage (3.8%). In addition, significantly more patients demonstrated increased BMD from baseline in both the lumbar spine and total hip in the 2-mg/mo and 3-mg/mo groups compared with the daily oral 2.5-mg group.
The study included 1,395 women aged 55-80 years with postmenopausal osteoporosis. In addition to their ibandronate regimens, women in all treatment groups received 500 mg of calcium and 400 IU of vitamin D daily. The incidence of renal adverse events such as urinary incontinence, renal impairment, or nephrolithiasis, was 3% or less across all treatment arms, and there were no significant changes in serum creatinine levels in any of the patients compared with baseline. The incidence of flu-like illness was low as well—3.3%, 3.2%, and 0.6% in the 2-mg/2 mo, 3-mg/3 mo, and 2.5-mg oral groups, respectively.
In addition, the overall incidence of clinical fractures, including vertebral fractures, was 3.1%, and did not differ significantly among the three groups, although it was slightly higher in the oral group (3.7%) compared with the 2-mg/2 mo group (2.9%) and the 3-mg/3 mo group (2.8%).
Dr. Bolognese is a consultant for Eli Lilly & Co. and Procter & Gamble Co., and has received grants or research support from Aventis Pharmaceuticals Inc., Pfizer Inc., Lilly, and Wyeth.
WASHINGTON — Postmenopausal women with osteoporosis who can't tolerate oral ibandronate may welcome an intravenous option, Michael Bolognese, M.D., reported at an international symposium sponsored by the National Osteoporosis Foundation.
One-year results from the Dosing Intravenous Administration (DIVA) study, an ongoing randomized, double-blind, phase III trial, showed that rapid injections of ibandronate (Boniva) in amounts of 2 mg every 2 months or 3 mg every 3 months were more effective than the standard oral daily dose of 2.5 mg at increasing bone mineral density (BMD), Dr. Bolognese of Bethesda (Md.) Health Research and his colleagues wrote in a poster presentation of their findings.
The increases in the BMD at the lumbar spine were significantly greater for women on both the 2-mg/2 mo (5.1%) and 3-mg/3 mo (4.8%) regimens compared with the 2.5-mg daily oral dosage (3.8%). In addition, significantly more patients demonstrated increased BMD from baseline in both the lumbar spine and total hip in the 2-mg/mo and 3-mg/mo groups compared with the daily oral 2.5-mg group.
The study included 1,395 women aged 55-80 years with postmenopausal osteoporosis. In addition to their ibandronate regimens, women in all treatment groups received 500 mg of calcium and 400 IU of vitamin D daily. The incidence of renal adverse events such as urinary incontinence, renal impairment, or nephrolithiasis, was 3% or less across all treatment arms, and there were no significant changes in serum creatinine levels in any of the patients compared with baseline. The incidence of flu-like illness was low as well—3.3%, 3.2%, and 0.6% in the 2-mg/2 mo, 3-mg/3 mo, and 2.5-mg oral groups, respectively.
In addition, the overall incidence of clinical fractures, including vertebral fractures, was 3.1%, and did not differ significantly among the three groups, although it was slightly higher in the oral group (3.7%) compared with the 2-mg/2 mo group (2.9%) and the 3-mg/3 mo group (2.8%).
Dr. Bolognese is a consultant for Eli Lilly & Co. and Procter & Gamble Co., and has received grants or research support from Aventis Pharmaceuticals Inc., Pfizer Inc., Lilly, and Wyeth.
WASHINGTON — Postmenopausal women with osteoporosis who can't tolerate oral ibandronate may welcome an intravenous option, Michael Bolognese, M.D., reported at an international symposium sponsored by the National Osteoporosis Foundation.
One-year results from the Dosing Intravenous Administration (DIVA) study, an ongoing randomized, double-blind, phase III trial, showed that rapid injections of ibandronate (Boniva) in amounts of 2 mg every 2 months or 3 mg every 3 months were more effective than the standard oral daily dose of 2.5 mg at increasing bone mineral density (BMD), Dr. Bolognese of Bethesda (Md.) Health Research and his colleagues wrote in a poster presentation of their findings.
The increases in the BMD at the lumbar spine were significantly greater for women on both the 2-mg/2 mo (5.1%) and 3-mg/3 mo (4.8%) regimens compared with the 2.5-mg daily oral dosage (3.8%). In addition, significantly more patients demonstrated increased BMD from baseline in both the lumbar spine and total hip in the 2-mg/mo and 3-mg/mo groups compared with the daily oral 2.5-mg group.
The study included 1,395 women aged 55-80 years with postmenopausal osteoporosis. In addition to their ibandronate regimens, women in all treatment groups received 500 mg of calcium and 400 IU of vitamin D daily. The incidence of renal adverse events such as urinary incontinence, renal impairment, or nephrolithiasis, was 3% or less across all treatment arms, and there were no significant changes in serum creatinine levels in any of the patients compared with baseline. The incidence of flu-like illness was low as well—3.3%, 3.2%, and 0.6% in the 2-mg/2 mo, 3-mg/3 mo, and 2.5-mg oral groups, respectively.
In addition, the overall incidence of clinical fractures, including vertebral fractures, was 3.1%, and did not differ significantly among the three groups, although it was slightly higher in the oral group (3.7%) compared with the 2-mg/2 mo group (2.9%) and the 3-mg/3 mo group (2.8%).
Dr. Bolognese is a consultant for Eli Lilly & Co. and Procter & Gamble Co., and has received grants or research support from Aventis Pharmaceuticals Inc., Pfizer Inc., Lilly, and Wyeth.
Vitamin D Deficiency Rampant
WASHINGTON — Vitamin D levels are inadequate in up to half of postmenopausal women who receive treatment for osteoporosis, Ethel S. Siris, M.D., reported at an international symposium sponsored by the National Osteoporosis Foundation.
Vitamin D inadequacy was significantly worse among women who took less than 400 IU of vitamin D supplementation daily, compared with women who took at least 400 IU of vitamin D daily (63% vs. 45%).
Previous study findings suggest that serum 25-hydroxyvitamin D concentrations of at least 30 ng/mL are needed to stabilize serum parathyroid hormone levels, Dr. Siris, director of the metabolic bone diseases program at Columbia University, New York, and her colleagues, wrote in a poster presentation.
In a cross-sectional, observational study conducted between November 2003 and March 2004, the investigators collected blood samples from 1,536 postmenopausal women, mean age 71 years, at 61 sites throughout North America. They used several cut points of serum 25-hydroxyvitamin D to define inadequacy—less than 9 ng/mL, less than 20 ng/mL, less than 25 ng/mL, and less than 30 ng/mL.
Parathyroid hormone values stabilized among patients with serum 25-hydroxyvitamin D concentrations of at least 29.8 ng/mL, which suggests that concentrations of approximately 30 ng/mL are important for healthy parathyroid levels.
Additional factors significantly related to vitamin D inadequacy in a multivariate analysis included age older than 80 years, BMI greater than 30, lack of exercise, and lack of physician counseling about the importance of vitamin D. More than half (59%) of the women reported that they had not discussed vitamin D with a doctor.
Dr. Siris is a paid consultant for Eli Lilly & Co., Merck & Co., Sanofi Aventis, Procter & Gamble Pharmaceuticals, and Novartis.
WASHINGTON — Vitamin D levels are inadequate in up to half of postmenopausal women who receive treatment for osteoporosis, Ethel S. Siris, M.D., reported at an international symposium sponsored by the National Osteoporosis Foundation.
Vitamin D inadequacy was significantly worse among women who took less than 400 IU of vitamin D supplementation daily, compared with women who took at least 400 IU of vitamin D daily (63% vs. 45%).
Previous study findings suggest that serum 25-hydroxyvitamin D concentrations of at least 30 ng/mL are needed to stabilize serum parathyroid hormone levels, Dr. Siris, director of the metabolic bone diseases program at Columbia University, New York, and her colleagues, wrote in a poster presentation.
In a cross-sectional, observational study conducted between November 2003 and March 2004, the investigators collected blood samples from 1,536 postmenopausal women, mean age 71 years, at 61 sites throughout North America. They used several cut points of serum 25-hydroxyvitamin D to define inadequacy—less than 9 ng/mL, less than 20 ng/mL, less than 25 ng/mL, and less than 30 ng/mL.
Parathyroid hormone values stabilized among patients with serum 25-hydroxyvitamin D concentrations of at least 29.8 ng/mL, which suggests that concentrations of approximately 30 ng/mL are important for healthy parathyroid levels.
Additional factors significantly related to vitamin D inadequacy in a multivariate analysis included age older than 80 years, BMI greater than 30, lack of exercise, and lack of physician counseling about the importance of vitamin D. More than half (59%) of the women reported that they had not discussed vitamin D with a doctor.
Dr. Siris is a paid consultant for Eli Lilly & Co., Merck & Co., Sanofi Aventis, Procter & Gamble Pharmaceuticals, and Novartis.
WASHINGTON — Vitamin D levels are inadequate in up to half of postmenopausal women who receive treatment for osteoporosis, Ethel S. Siris, M.D., reported at an international symposium sponsored by the National Osteoporosis Foundation.
Vitamin D inadequacy was significantly worse among women who took less than 400 IU of vitamin D supplementation daily, compared with women who took at least 400 IU of vitamin D daily (63% vs. 45%).
Previous study findings suggest that serum 25-hydroxyvitamin D concentrations of at least 30 ng/mL are needed to stabilize serum parathyroid hormone levels, Dr. Siris, director of the metabolic bone diseases program at Columbia University, New York, and her colleagues, wrote in a poster presentation.
In a cross-sectional, observational study conducted between November 2003 and March 2004, the investigators collected blood samples from 1,536 postmenopausal women, mean age 71 years, at 61 sites throughout North America. They used several cut points of serum 25-hydroxyvitamin D to define inadequacy—less than 9 ng/mL, less than 20 ng/mL, less than 25 ng/mL, and less than 30 ng/mL.
Parathyroid hormone values stabilized among patients with serum 25-hydroxyvitamin D concentrations of at least 29.8 ng/mL, which suggests that concentrations of approximately 30 ng/mL are important for healthy parathyroid levels.
Additional factors significantly related to vitamin D inadequacy in a multivariate analysis included age older than 80 years, BMI greater than 30, lack of exercise, and lack of physician counseling about the importance of vitamin D. More than half (59%) of the women reported that they had not discussed vitamin D with a doctor.
Dr. Siris is a paid consultant for Eli Lilly & Co., Merck & Co., Sanofi Aventis, Procter & Gamble Pharmaceuticals, and Novartis.
Past Vertebral Fractures Predict Future Risk
WASHINGTON — The risk of vertebral fragility fractures is threefold higher among postmenopausal women with at least one prevalent radiographic fracture, compared with those without such a history, Ethel S. Siris, M.D., said at an international symposium sponsored by the National Osteoporosis Foundation.
Awareness of previous vertebral fractures can help physicians evaluate vertebral fragility and target osteoporosis therapy appropriately, Dr. Siris, a professor of clinical medicine at Columbia University, New York and her colleagues, said in a poster presented at the meeting.
Their review of data on 2,651 postmenopausal women, mean age 67 years, included 1,181 women with prevalent vertebral fractures and assessed fracture risk independent of lumbar spine bone mineral density. Overall, the greater the number of prevalent vertebral fractures, the greater the risk of sustaining subsequent fractures.
Patients with three or more fractures had as much as an eightfold increased risk. Greater severity scores on the semi-quantitative deformity scale were associated with as much as an 11-fold increase in the risk of fracture.
Dr. Siris is a consultant for and has received honoraria from Eli Lilly & Co., Merck & Co., Sanofi-Aventis, Procter & Gamble Pharmaceuticals, and Novartis.
WASHINGTON — The risk of vertebral fragility fractures is threefold higher among postmenopausal women with at least one prevalent radiographic fracture, compared with those without such a history, Ethel S. Siris, M.D., said at an international symposium sponsored by the National Osteoporosis Foundation.
Awareness of previous vertebral fractures can help physicians evaluate vertebral fragility and target osteoporosis therapy appropriately, Dr. Siris, a professor of clinical medicine at Columbia University, New York and her colleagues, said in a poster presented at the meeting.
Their review of data on 2,651 postmenopausal women, mean age 67 years, included 1,181 women with prevalent vertebral fractures and assessed fracture risk independent of lumbar spine bone mineral density. Overall, the greater the number of prevalent vertebral fractures, the greater the risk of sustaining subsequent fractures.
Patients with three or more fractures had as much as an eightfold increased risk. Greater severity scores on the semi-quantitative deformity scale were associated with as much as an 11-fold increase in the risk of fracture.
Dr. Siris is a consultant for and has received honoraria from Eli Lilly & Co., Merck & Co., Sanofi-Aventis, Procter & Gamble Pharmaceuticals, and Novartis.
WASHINGTON — The risk of vertebral fragility fractures is threefold higher among postmenopausal women with at least one prevalent radiographic fracture, compared with those without such a history, Ethel S. Siris, M.D., said at an international symposium sponsored by the National Osteoporosis Foundation.
Awareness of previous vertebral fractures can help physicians evaluate vertebral fragility and target osteoporosis therapy appropriately, Dr. Siris, a professor of clinical medicine at Columbia University, New York and her colleagues, said in a poster presented at the meeting.
Their review of data on 2,651 postmenopausal women, mean age 67 years, included 1,181 women with prevalent vertebral fractures and assessed fracture risk independent of lumbar spine bone mineral density. Overall, the greater the number of prevalent vertebral fractures, the greater the risk of sustaining subsequent fractures.
Patients with three or more fractures had as much as an eightfold increased risk. Greater severity scores on the semi-quantitative deformity scale were associated with as much as an 11-fold increase in the risk of fracture.
Dr. Siris is a consultant for and has received honoraria from Eli Lilly & Co., Merck & Co., Sanofi-Aventis, Procter & Gamble Pharmaceuticals, and Novartis.
Consider T Score as Just One Factor in Osteoporosis Treatment Decisionmaking
NEW YORK — While bone mineral density T scores clearly are predictive of a postmenopausal woman's osteoporotic fracture risk, treatment decisions should take into account other factors, including her overall health and history of previous fractures, Stephen Honig, M.D., said at a rheumatology meeting sponsored by New York University.
“We have to do better than the T score in deciding who needs treatment for osteoporosis, because the long-term use of bisphosphonates has not been determined to be safe,” said Dr. Honig, director of the osteoporosis center at the Hospital for Joint Diseases Spine Center in New York.
Very long-term bisphosphonate therapy may lead to oversuppression of bone turnover, he said. This superhardening can hinder subsequent fracture healing, as was seen in a recent report of nine patients who sustained spontaneous, nonhealing fractures while on alendronate therapy (J. Clin. Endocrinol. Metab. 2005;90:1294-301).
These patients showed histomorphometric evidence of markedly suppressed bone formation, Dr. Honig said.
This new finding has heightened interest in targeting osteoporosis treatment. Research findings have begun to provide guidance on which patients can most benefit from treatment.
Most notable was the National Osteoporosis Risk Assessment (NORA) study, which enrolled 200,160 postmenopausal women aged 50 and older. In that study, bone mineral density (BMD) measurements were obtained at baseline, and the participants were followed for 1 year.
At follow up, one-third of all fractures and one-fifth of all hip fractures in particular occurred in women aged 50-64. Although the majority of fractures did occur in women 65 and older, the high number in the younger cohort “was a little surprising,” said Dr. Honig.
Another finding that emerged from NORA was that 80% of the women who had fractures during the yearlong study had T scores that were higher than -2.5 and therefore did not meet the World Health Organization definition of osteoporosis. Most fell between -1 and -2.5, the osteopenic range, he said.
“We want to identify patients at risk in this middle range and not wait until they have obvious fractures,” he said.
The NORA investigators subsequently followed 57,421 osteopenic women and developed an algorithm for determining risk. As it turns out, identifying patients with a previous fracture, a T score below -1.8, a self-reported health status of fair or poor, and poor mobility were all factors significantly predictive of fracture risk (Arch. Intern. Med. 2004;164:1113-20).
Another prospective study conducted in France followed 672 healthy postmenopausal women for more than 5 years, and found an annual incidence of osteoporotic fractures of 21 per 1,000 women per year (Bone 2003;32:78-85). The French investigators identified the key risk factors (in order of importance) to be: a past fracture, hip BMD, low physical activity, low grip strength, age over 65, maternal fracture history, and past falls.
Other studies have also suggested additional risk factors, including smoking, low body mass index, and increased markers of bone absorption.
Based on the available data and tools at hand, Dr. Honig recommends that clinicians now consider treatment for the following patients:
▸ Women 65 and older, with or without a history of fracture, who have low BMD or other risk factors, such as low BMI and family history.
▸ Women 50 and older with a previous fracture and a T score of -1.8 or less.
▸ Women in poor overall health with mobility problems and low BMD.
▸ Women with low BMD and increased markers of bone resorption.
But questions remain, he said. How long can a bisphosphonate be used? When should teriparatide or a selective estrogen receptor modulator be used? What place does hormone replacement therapy have in treatment strategies? “There is some new evidence that postmenopausal women with certain levels of endogenous estradiol have a lower incidence of fractures. This may translate into using very low-dose [hormone therapy], which conceivably could be safer than what was seen in the Women's Health Initiative,” he said.
Dr. Honig disclosed that he receives support from Eli Lilly & Co. and is on the speakers' bureau of Sanofi-Aventis.
NEW YORK — While bone mineral density T scores clearly are predictive of a postmenopausal woman's osteoporotic fracture risk, treatment decisions should take into account other factors, including her overall health and history of previous fractures, Stephen Honig, M.D., said at a rheumatology meeting sponsored by New York University.
“We have to do better than the T score in deciding who needs treatment for osteoporosis, because the long-term use of bisphosphonates has not been determined to be safe,” said Dr. Honig, director of the osteoporosis center at the Hospital for Joint Diseases Spine Center in New York.
Very long-term bisphosphonate therapy may lead to oversuppression of bone turnover, he said. This superhardening can hinder subsequent fracture healing, as was seen in a recent report of nine patients who sustained spontaneous, nonhealing fractures while on alendronate therapy (J. Clin. Endocrinol. Metab. 2005;90:1294-301).
These patients showed histomorphometric evidence of markedly suppressed bone formation, Dr. Honig said.
This new finding has heightened interest in targeting osteoporosis treatment. Research findings have begun to provide guidance on which patients can most benefit from treatment.
Most notable was the National Osteoporosis Risk Assessment (NORA) study, which enrolled 200,160 postmenopausal women aged 50 and older. In that study, bone mineral density (BMD) measurements were obtained at baseline, and the participants were followed for 1 year.
At follow up, one-third of all fractures and one-fifth of all hip fractures in particular occurred in women aged 50-64. Although the majority of fractures did occur in women 65 and older, the high number in the younger cohort “was a little surprising,” said Dr. Honig.
Another finding that emerged from NORA was that 80% of the women who had fractures during the yearlong study had T scores that were higher than -2.5 and therefore did not meet the World Health Organization definition of osteoporosis. Most fell between -1 and -2.5, the osteopenic range, he said.
“We want to identify patients at risk in this middle range and not wait until they have obvious fractures,” he said.
The NORA investigators subsequently followed 57,421 osteopenic women and developed an algorithm for determining risk. As it turns out, identifying patients with a previous fracture, a T score below -1.8, a self-reported health status of fair or poor, and poor mobility were all factors significantly predictive of fracture risk (Arch. Intern. Med. 2004;164:1113-20).
Another prospective study conducted in France followed 672 healthy postmenopausal women for more than 5 years, and found an annual incidence of osteoporotic fractures of 21 per 1,000 women per year (Bone 2003;32:78-85). The French investigators identified the key risk factors (in order of importance) to be: a past fracture, hip BMD, low physical activity, low grip strength, age over 65, maternal fracture history, and past falls.
Other studies have also suggested additional risk factors, including smoking, low body mass index, and increased markers of bone absorption.
Based on the available data and tools at hand, Dr. Honig recommends that clinicians now consider treatment for the following patients:
▸ Women 65 and older, with or without a history of fracture, who have low BMD or other risk factors, such as low BMI and family history.
▸ Women 50 and older with a previous fracture and a T score of -1.8 or less.
▸ Women in poor overall health with mobility problems and low BMD.
▸ Women with low BMD and increased markers of bone resorption.
But questions remain, he said. How long can a bisphosphonate be used? When should teriparatide or a selective estrogen receptor modulator be used? What place does hormone replacement therapy have in treatment strategies? “There is some new evidence that postmenopausal women with certain levels of endogenous estradiol have a lower incidence of fractures. This may translate into using very low-dose [hormone therapy], which conceivably could be safer than what was seen in the Women's Health Initiative,” he said.
Dr. Honig disclosed that he receives support from Eli Lilly & Co. and is on the speakers' bureau of Sanofi-Aventis.
NEW YORK — While bone mineral density T scores clearly are predictive of a postmenopausal woman's osteoporotic fracture risk, treatment decisions should take into account other factors, including her overall health and history of previous fractures, Stephen Honig, M.D., said at a rheumatology meeting sponsored by New York University.
“We have to do better than the T score in deciding who needs treatment for osteoporosis, because the long-term use of bisphosphonates has not been determined to be safe,” said Dr. Honig, director of the osteoporosis center at the Hospital for Joint Diseases Spine Center in New York.
Very long-term bisphosphonate therapy may lead to oversuppression of bone turnover, he said. This superhardening can hinder subsequent fracture healing, as was seen in a recent report of nine patients who sustained spontaneous, nonhealing fractures while on alendronate therapy (J. Clin. Endocrinol. Metab. 2005;90:1294-301).
These patients showed histomorphometric evidence of markedly suppressed bone formation, Dr. Honig said.
This new finding has heightened interest in targeting osteoporosis treatment. Research findings have begun to provide guidance on which patients can most benefit from treatment.
Most notable was the National Osteoporosis Risk Assessment (NORA) study, which enrolled 200,160 postmenopausal women aged 50 and older. In that study, bone mineral density (BMD) measurements were obtained at baseline, and the participants were followed for 1 year.
At follow up, one-third of all fractures and one-fifth of all hip fractures in particular occurred in women aged 50-64. Although the majority of fractures did occur in women 65 and older, the high number in the younger cohort “was a little surprising,” said Dr. Honig.
Another finding that emerged from NORA was that 80% of the women who had fractures during the yearlong study had T scores that were higher than -2.5 and therefore did not meet the World Health Organization definition of osteoporosis. Most fell between -1 and -2.5, the osteopenic range, he said.
“We want to identify patients at risk in this middle range and not wait until they have obvious fractures,” he said.
The NORA investigators subsequently followed 57,421 osteopenic women and developed an algorithm for determining risk. As it turns out, identifying patients with a previous fracture, a T score below -1.8, a self-reported health status of fair or poor, and poor mobility were all factors significantly predictive of fracture risk (Arch. Intern. Med. 2004;164:1113-20).
Another prospective study conducted in France followed 672 healthy postmenopausal women for more than 5 years, and found an annual incidence of osteoporotic fractures of 21 per 1,000 women per year (Bone 2003;32:78-85). The French investigators identified the key risk factors (in order of importance) to be: a past fracture, hip BMD, low physical activity, low grip strength, age over 65, maternal fracture history, and past falls.
Other studies have also suggested additional risk factors, including smoking, low body mass index, and increased markers of bone absorption.
Based on the available data and tools at hand, Dr. Honig recommends that clinicians now consider treatment for the following patients:
▸ Women 65 and older, with or without a history of fracture, who have low BMD or other risk factors, such as low BMI and family history.
▸ Women 50 and older with a previous fracture and a T score of -1.8 or less.
▸ Women in poor overall health with mobility problems and low BMD.
▸ Women with low BMD and increased markers of bone resorption.
But questions remain, he said. How long can a bisphosphonate be used? When should teriparatide or a selective estrogen receptor modulator be used? What place does hormone replacement therapy have in treatment strategies? “There is some new evidence that postmenopausal women with certain levels of endogenous estradiol have a lower incidence of fractures. This may translate into using very low-dose [hormone therapy], which conceivably could be safer than what was seen in the Women's Health Initiative,” he said.
Dr. Honig disclosed that he receives support from Eli Lilly & Co. and is on the speakers' bureau of Sanofi-Aventis.
Pap Smear Cell Patterns May Signal Bone Loss
HARROGATE, ENGLAND — Women whose Pap smears reveal atrophic cell patterns may be at greater risk for osteopenia and osteoporosis than women whose smears show mature cell patterns, a study has shown.
The findings suggest that routine Pap testing could be a useful and inexpensive screening tool for identifying women who are at risk for the degenerative bone disorders, Alenka Repse-Fokter, M.D., reported in a poster presentation at the annual conference of the National Osteoporosis Society.
Given limited medical resources, the ability to use an already existing and widely performed screening protocol to help identify women with osteoporosis “would be highly appreciated,” she said.
Dr. Repse-Fokter and colleagues at Celje (Slovenia) General Hospital assessed the Pap smear results and dual-energy x-ray absorptiometry (DXA) bone density measurements of 66 women between 46 and 67 years old.
The women had received the Pap smears for routine cervical cancer screening and were invited to undergo bone mineral density measurement as part of the investigation.
None of the women used hormonal contraception or hormone therapy, Dr. Repse-Fokter said.
The investigator and her associates grouped the smears into atrophic and mature cell patterns, which can be easily recognized during the screening for cervical dysplasia or cancer.
“In routine light microscopy, atrophic cells appear much smaller than cells in mature smear patterns,” she noted.
The smear patterns were then compared with the patients' T values measured by DXA on the femoral neck and lumbar spine.
Overall, the T scores were significantly lower in the atrophic smear group. Of the 33 women with atrophic smears, 13 had osteopenia and 15 had osteoporosis. Among the 33 women whose smears showed mature cell patterns, 9 had osteopenia and 24 had normal bone density, Dr. Repse-Fokter said.
The sensitivity, specificity, and positive predictive value of the findings were, respectively, 76%, 83%, and 85%.
The findings of a correlation between smear patterns and degenerative bone disease support the investigators' findings from a previous study that revealed a highly significant association between atrophic smear patterns and low bone mineral density.
“This means that a significant number of women with low bone mineral density who are at high risk [for osteoporotic disease] could be identified in parallel with routine Pap testing for cervical cancer screening without added costs,” Dr. Repse-Fokter said.
Although further studies on larger populations are needed, “we strongly suggest that women with atrophic Pap smear patterns be closely followed as recommended by the American National Osteoporosis Foundation,” according to Dr. Repse-Fokter and her colleagues.
HARROGATE, ENGLAND — Women whose Pap smears reveal atrophic cell patterns may be at greater risk for osteopenia and osteoporosis than women whose smears show mature cell patterns, a study has shown.
The findings suggest that routine Pap testing could be a useful and inexpensive screening tool for identifying women who are at risk for the degenerative bone disorders, Alenka Repse-Fokter, M.D., reported in a poster presentation at the annual conference of the National Osteoporosis Society.
Given limited medical resources, the ability to use an already existing and widely performed screening protocol to help identify women with osteoporosis “would be highly appreciated,” she said.
Dr. Repse-Fokter and colleagues at Celje (Slovenia) General Hospital assessed the Pap smear results and dual-energy x-ray absorptiometry (DXA) bone density measurements of 66 women between 46 and 67 years old.
The women had received the Pap smears for routine cervical cancer screening and were invited to undergo bone mineral density measurement as part of the investigation.
None of the women used hormonal contraception or hormone therapy, Dr. Repse-Fokter said.
The investigator and her associates grouped the smears into atrophic and mature cell patterns, which can be easily recognized during the screening for cervical dysplasia or cancer.
“In routine light microscopy, atrophic cells appear much smaller than cells in mature smear patterns,” she noted.
The smear patterns were then compared with the patients' T values measured by DXA on the femoral neck and lumbar spine.
Overall, the T scores were significantly lower in the atrophic smear group. Of the 33 women with atrophic smears, 13 had osteopenia and 15 had osteoporosis. Among the 33 women whose smears showed mature cell patterns, 9 had osteopenia and 24 had normal bone density, Dr. Repse-Fokter said.
The sensitivity, specificity, and positive predictive value of the findings were, respectively, 76%, 83%, and 85%.
The findings of a correlation between smear patterns and degenerative bone disease support the investigators' findings from a previous study that revealed a highly significant association between atrophic smear patterns and low bone mineral density.
“This means that a significant number of women with low bone mineral density who are at high risk [for osteoporotic disease] could be identified in parallel with routine Pap testing for cervical cancer screening without added costs,” Dr. Repse-Fokter said.
Although further studies on larger populations are needed, “we strongly suggest that women with atrophic Pap smear patterns be closely followed as recommended by the American National Osteoporosis Foundation,” according to Dr. Repse-Fokter and her colleagues.
HARROGATE, ENGLAND — Women whose Pap smears reveal atrophic cell patterns may be at greater risk for osteopenia and osteoporosis than women whose smears show mature cell patterns, a study has shown.
The findings suggest that routine Pap testing could be a useful and inexpensive screening tool for identifying women who are at risk for the degenerative bone disorders, Alenka Repse-Fokter, M.D., reported in a poster presentation at the annual conference of the National Osteoporosis Society.
Given limited medical resources, the ability to use an already existing and widely performed screening protocol to help identify women with osteoporosis “would be highly appreciated,” she said.
Dr. Repse-Fokter and colleagues at Celje (Slovenia) General Hospital assessed the Pap smear results and dual-energy x-ray absorptiometry (DXA) bone density measurements of 66 women between 46 and 67 years old.
The women had received the Pap smears for routine cervical cancer screening and were invited to undergo bone mineral density measurement as part of the investigation.
None of the women used hormonal contraception or hormone therapy, Dr. Repse-Fokter said.
The investigator and her associates grouped the smears into atrophic and mature cell patterns, which can be easily recognized during the screening for cervical dysplasia or cancer.
“In routine light microscopy, atrophic cells appear much smaller than cells in mature smear patterns,” she noted.
The smear patterns were then compared with the patients' T values measured by DXA on the femoral neck and lumbar spine.
Overall, the T scores were significantly lower in the atrophic smear group. Of the 33 women with atrophic smears, 13 had osteopenia and 15 had osteoporosis. Among the 33 women whose smears showed mature cell patterns, 9 had osteopenia and 24 had normal bone density, Dr. Repse-Fokter said.
The sensitivity, specificity, and positive predictive value of the findings were, respectively, 76%, 83%, and 85%.
The findings of a correlation between smear patterns and degenerative bone disease support the investigators' findings from a previous study that revealed a highly significant association between atrophic smear patterns and low bone mineral density.
“This means that a significant number of women with low bone mineral density who are at high risk [for osteoporotic disease] could be identified in parallel with routine Pap testing for cervical cancer screening without added costs,” Dr. Repse-Fokter said.
Although further studies on larger populations are needed, “we strongly suggest that women with atrophic Pap smear patterns be closely followed as recommended by the American National Osteoporosis Foundation,” according to Dr. Repse-Fokter and her colleagues.