Osteoarthritis

VIENNA — A single 5-mg IV infusion of zoledronic acid produces significantly greater therapeutic efficacy and a longer-lasting biochemical remission than 2 full months of oral risedronate at 30 mg/day in patients with Paget's disease of bone, Jacques P. Brown, M.D., reported at the annual European congress of rheumatology.

Zoledronic acid (Zometa) is clearly the clinically advantageous drug, both in bisphosphonate-naive patients and in those previously on risedronate (Actonel) or other oral bisphosphonates, added Dr. Brown of the Centre Hospitalier Universitaire de Québec, Sainte-Foy.

At the meeting, sponsored by the European League Against Rheumatism, he presented a pooled analysis combining the data from two randomized, double-blind, multicenter trials of 349 patients with Paget's disease of bone. Participants received a single 15-minute 5-mg infusion of zoledronic acid or 30 mg/day of oral risedronate for 2 months.

The primary end point was a reduction of 75% or more in excess serum alkaline phosphatase (SAP) at 6 months. Ninety-six percent of patients in the zoledronic acid group achieved it vs. 74% in the risedronate arm. Eighty-nine percent of zoledronic acid-treated patients achieved normalization of SAP at the 6-month mark, compared with 58% on risedronate.

The therapeutic response to zoledronic acid was significantly swifter and longer lasting than the response to risedronate. At the 1-month mark, 20% of the zoledronic acid group had achieved at least a 75% reduction in excess SAP, while just 1% of the risedronate group did. At 2 months, 90% of zoledronic acid-treated patients showed a therapeutic response vs. 47% on risedronate. Moreover, only 2 patients in the zoledronic acid group lost their therapeutic response between months 6 and 18, while 36 in the risedronate group did.

One hundred percent of patients randomized to zoledronic acid after having previously been on an oral bisphosphonate had a therapeutic response to the intravenous third-generation bisphosphonate. In contrast, only 30% of patients previously on risedronate or another oral bisphosphonate achieved a therapeutic response when randomized to risedronate in the study.

Side effects of zoledronic acid include myalgia, fatigue, headache, rigors, nausea, and bone pain. In these studies, the effects were mild to moderate in nature, often began within 3 days after the first dose, and typically lasted less than 4 days.

The studies were funded by Novartis Pharmaceuticals.

VIENNA — A single 5-mg IV infusion of zoledronic acid produces significantly greater therapeutic efficacy and a longer-lasting biochemical remission than 2 full months of oral risedronate at 30 mg/day in patients with Paget's disease of bone, Jacques P. Brown, M.D., reported at the annual European congress of rheumatology.

Zoledronic acid (Zometa) is clearly the clinically advantageous drug, both in bisphosphonate-naive patients and in those previously on risedronate (Actonel) or other oral bisphosphonates, added Dr. Brown of the Centre Hospitalier Universitaire de Québec, Sainte-Foy.

At the meeting, sponsored by the European League Against Rheumatism, he presented a pooled analysis combining the data from two randomized, double-blind, multicenter trials of 349 patients with Paget's disease of bone. Participants received a single 15-minute 5-mg infusion of zoledronic acid or 30 mg/day of oral risedronate for 2 months.

The primary end point was a reduction of 75% or more in excess serum alkaline phosphatase (SAP) at 6 months. Ninety-six percent of patients in the zoledronic acid group achieved it vs. 74% in the risedronate arm. Eighty-nine percent of zoledronic acid-treated patients achieved normalization of SAP at the 6-month mark, compared with 58% on risedronate.

The therapeutic response to zoledronic acid was significantly swifter and longer lasting than the response to risedronate. At the 1-month mark, 20% of the zoledronic acid group had achieved at least a 75% reduction in excess SAP, while just 1% of the risedronate group did. At 2 months, 90% of zoledronic acid-treated patients showed a therapeutic response vs. 47% on risedronate. Moreover, only 2 patients in the zoledronic acid group lost their therapeutic response between months 6 and 18, while 36 in the risedronate group did.

One hundred percent of patients randomized to zoledronic acid after having previously been on an oral bisphosphonate had a therapeutic response to the intravenous third-generation bisphosphonate. In contrast, only 30% of patients previously on risedronate or another oral bisphosphonate achieved a therapeutic response when randomized to risedronate in the study.

Side effects of zoledronic acid include myalgia, fatigue, headache, rigors, nausea, and bone pain. In these studies, the effects were mild to moderate in nature, often began within 3 days after the first dose, and typically lasted less than 4 days.

The studies were funded by Novartis Pharmaceuticals.

VIENNA — A single 5-mg IV infusion of zoledronic acid produces significantly greater therapeutic efficacy and a longer-lasting biochemical remission than 2 full months of oral risedronate at 30 mg/day in patients with Paget's disease of bone, Jacques P. Brown, M.D., reported at the annual European congress of rheumatology.

Zoledronic acid (Zometa) is clearly the clinically advantageous drug, both in bisphosphonate-naive patients and in those previously on risedronate (Actonel) or other oral bisphosphonates, added Dr. Brown of the Centre Hospitalier Universitaire de Québec, Sainte-Foy.

At the meeting, sponsored by the European League Against Rheumatism, he presented a pooled analysis combining the data from two randomized, double-blind, multicenter trials of 349 patients with Paget's disease of bone. Participants received a single 15-minute 5-mg infusion of zoledronic acid or 30 mg/day of oral risedronate for 2 months.

The primary end point was a reduction of 75% or more in excess serum alkaline phosphatase (SAP) at 6 months. Ninety-six percent of patients in the zoledronic acid group achieved it vs. 74% in the risedronate arm. Eighty-nine percent of zoledronic acid-treated patients achieved normalization of SAP at the 6-month mark, compared with 58% on risedronate.

The therapeutic response to zoledronic acid was significantly swifter and longer lasting than the response to risedronate. At the 1-month mark, 20% of the zoledronic acid group had achieved at least a 75% reduction in excess SAP, while just 1% of the risedronate group did. At 2 months, 90% of zoledronic acid-treated patients showed a therapeutic response vs. 47% on risedronate. Moreover, only 2 patients in the zoledronic acid group lost their therapeutic response between months 6 and 18, while 36 in the risedronate group did.

One hundred percent of patients randomized to zoledronic acid after having previously been on an oral bisphosphonate had a therapeutic response to the intravenous third-generation bisphosphonate. In contrast, only 30% of patients previously on risedronate or another oral bisphosphonate achieved a therapeutic response when randomized to risedronate in the study.

Side effects of zoledronic acid include myalgia, fatigue, headache, rigors, nausea, and bone pain. In these studies, the effects were mild to moderate in nature, often began within 3 days after the first dose, and typically lasted less than 4 days.

The studies were funded by Novartis Pharmaceuticals.

SAN FRANCISCO — A majority of 1,536 elderly women taking medication to prevent or treat osteoporosis were deficient in vitamin D, a study of community-dwelling patients found.

The findings echo a previous study that found 56% of medical inpatients had vitamin D deficiency. “This is a very common problem” that deserves more attention, Dolores M. Shoback, M.D., said at a meeting on osteoporosis sponsored by the University of California, San Francisco.

Physicians should look more carefully for vitamin D deficiency in inpatients and outpatients, even those who are ambulatory, on prescription therapy for osteoporosis, and lacking risk factors for vitamin D deficiency—”many of the patients, probably, in our own practices,” said Dr. Shoback, professor of medicine at the university.

The recent outpatient study included postmenopausal women at 61 locations in North America who had been taking bisphosphonates, calcitonin, or a selective estrogen receptor modulator for at least 3 months under a physician's care to prevent or treat osteoporosis. They averaged 71 years in age, and were 92% white. Investigators administered a questionnaire to assess risk factors for vitamin D deficiency and measured the women's serum concentrations of parathyroid hormone (PTH) and 25-hydroxyvitamin D—known as 25(OH)D—the form of vitamin D stored in the body.

They found that 52% of the 1,536 women had levels of 25(OH)D lower than 30 ng/mL. Of these, 36% had levels below 25 ng/mL, and 18% were below 20 ng/mL, showing that most of the women with inadequate vitamin D were severely deficient (J. Clin. Endocrinol. Metab. 2005;90:3215–24).

“We aren't doing a good job with the people we're actively treating for osteoporosis,” said Dr. Shoback. Vitamin D deficiency is one of the most common causes of secondary osteoporosis.

Although there's no consensus on how much vitamin D the human body needs, the idea that 15–25 ng/mL is adequate has been replaced in the last few years by general cutoffs closer to 30 ng/mL or higher, she said. Some experts say people need at least 20 ng/mL 25(OH)D or else PTH levels rise and frank hyperparathyroidism develops. Others say that elderly people need 32–36 ng/mL to maximize intestinal calcium transport.

In the study patients tended to develop secondary hyperparathyroidism at 25(OH)D levels of 25 ng/mL and lower. Many physicians use PTH levels to help diagnose vitamin D deficiency, but the study found that high PTH is not 100% sensitive for low vitamin D. Only 75% of women with 25(OH)D levels of 0–9 ng/mL had secondary hyperparathyroidism. “This surprised me,” Dr. Shoback said.

Women who had not discussed vitamin D and bone health with their doctors were more likely to have 25(OH)D levels below 30 ng/mL. “Sometimes we think we're talking to the wall or ourselves, but these discussions actually may be having some kind of an impact,” Dr. Shoback said.

Other risk factors for vitamin D deficiency included age older than 80, a body mass index over 30 kg/m

Among patients with none of these risk factors, 32% had inadequate levels of 25(OH)D. “There just seem to be people out there who have vitamin D deficiency,” she said.

The 1998 inpatient study that detected vitamin D deficiency in 56% of 290 patients consecutively admitted to a hospital medical service also found that risk factors predicted the deficiency only about 60% of the time. The investigators recommended that medical inpatients be screened for vitamin D deficiency, she noted. Taking multivitamins did not prevent vitamin D deficiency in that study.

Dr. Shoback has no affiliation with companies that make vitamin D supplements.

SAN FRANCISCO — A majority of 1,536 elderly women taking medication to prevent or treat osteoporosis were deficient in vitamin D, a study of community-dwelling patients found.

The findings echo a previous study that found 56% of medical inpatients had vitamin D deficiency. “This is a very common problem” that deserves more attention, Dolores M. Shoback, M.D., said at a meeting on osteoporosis sponsored by the University of California, San Francisco.

Physicians should look more carefully for vitamin D deficiency in inpatients and outpatients, even those who are ambulatory, on prescription therapy for osteoporosis, and lacking risk factors for vitamin D deficiency—”many of the patients, probably, in our own practices,” said Dr. Shoback, professor of medicine at the university.

The recent outpatient study included postmenopausal women at 61 locations in North America who had been taking bisphosphonates, calcitonin, or a selective estrogen receptor modulator for at least 3 months under a physician's care to prevent or treat osteoporosis. They averaged 71 years in age, and were 92% white. Investigators administered a questionnaire to assess risk factors for vitamin D deficiency and measured the women's serum concentrations of parathyroid hormone (PTH) and 25-hydroxyvitamin D—known as 25(OH)D—the form of vitamin D stored in the body.

They found that 52% of the 1,536 women had levels of 25(OH)D lower than 30 ng/mL. Of these, 36% had levels below 25 ng/mL, and 18% were below 20 ng/mL, showing that most of the women with inadequate vitamin D were severely deficient (J. Clin. Endocrinol. Metab. 2005;90:3215–24).

“We aren't doing a good job with the people we're actively treating for osteoporosis,” said Dr. Shoback. Vitamin D deficiency is one of the most common causes of secondary osteoporosis.

Although there's no consensus on how much vitamin D the human body needs, the idea that 15–25 ng/mL is adequate has been replaced in the last few years by general cutoffs closer to 30 ng/mL or higher, she said. Some experts say people need at least 20 ng/mL 25(OH)D or else PTH levels rise and frank hyperparathyroidism develops. Others say that elderly people need 32–36 ng/mL to maximize intestinal calcium transport.

In the study patients tended to develop secondary hyperparathyroidism at 25(OH)D levels of 25 ng/mL and lower. Many physicians use PTH levels to help diagnose vitamin D deficiency, but the study found that high PTH is not 100% sensitive for low vitamin D. Only 75% of women with 25(OH)D levels of 0–9 ng/mL had secondary hyperparathyroidism. “This surprised me,” Dr. Shoback said.

Women who had not discussed vitamin D and bone health with their doctors were more likely to have 25(OH)D levels below 30 ng/mL. “Sometimes we think we're talking to the wall or ourselves, but these discussions actually may be having some kind of an impact,” Dr. Shoback said.

Other risk factors for vitamin D deficiency included age older than 80, a body mass index over 30 kg/m

Among patients with none of these risk factors, 32% had inadequate levels of 25(OH)D. “There just seem to be people out there who have vitamin D deficiency,” she said.

The 1998 inpatient study that detected vitamin D deficiency in 56% of 290 patients consecutively admitted to a hospital medical service also found that risk factors predicted the deficiency only about 60% of the time. The investigators recommended that medical inpatients be screened for vitamin D deficiency, she noted. Taking multivitamins did not prevent vitamin D deficiency in that study.

Dr. Shoback has no affiliation with companies that make vitamin D supplements.

SAN FRANCISCO — A majority of 1,536 elderly women taking medication to prevent or treat osteoporosis were deficient in vitamin D, a study of community-dwelling patients found.

The findings echo a previous study that found 56% of medical inpatients had vitamin D deficiency. “This is a very common problem” that deserves more attention, Dolores M. Shoback, M.D., said at a meeting on osteoporosis sponsored by the University of California, San Francisco.

Physicians should look more carefully for vitamin D deficiency in inpatients and outpatients, even those who are ambulatory, on prescription therapy for osteoporosis, and lacking risk factors for vitamin D deficiency—”many of the patients, probably, in our own practices,” said Dr. Shoback, professor of medicine at the university.

The recent outpatient study included postmenopausal women at 61 locations in North America who had been taking bisphosphonates, calcitonin, or a selective estrogen receptor modulator for at least 3 months under a physician's care to prevent or treat osteoporosis. They averaged 71 years in age, and were 92% white. Investigators administered a questionnaire to assess risk factors for vitamin D deficiency and measured the women's serum concentrations of parathyroid hormone (PTH) and 25-hydroxyvitamin D—known as 25(OH)D—the form of vitamin D stored in the body.

They found that 52% of the 1,536 women had levels of 25(OH)D lower than 30 ng/mL. Of these, 36% had levels below 25 ng/mL, and 18% were below 20 ng/mL, showing that most of the women with inadequate vitamin D were severely deficient (J. Clin. Endocrinol. Metab. 2005;90:3215–24).

“We aren't doing a good job with the people we're actively treating for osteoporosis,” said Dr. Shoback. Vitamin D deficiency is one of the most common causes of secondary osteoporosis.

Although there's no consensus on how much vitamin D the human body needs, the idea that 15–25 ng/mL is adequate has been replaced in the last few years by general cutoffs closer to 30 ng/mL or higher, she said. Some experts say people need at least 20 ng/mL 25(OH)D or else PTH levels rise and frank hyperparathyroidism develops. Others say that elderly people need 32–36 ng/mL to maximize intestinal calcium transport.

In the study patients tended to develop secondary hyperparathyroidism at 25(OH)D levels of 25 ng/mL and lower. Many physicians use PTH levels to help diagnose vitamin D deficiency, but the study found that high PTH is not 100% sensitive for low vitamin D. Only 75% of women with 25(OH)D levels of 0–9 ng/mL had secondary hyperparathyroidism. “This surprised me,” Dr. Shoback said.

Women who had not discussed vitamin D and bone health with their doctors were more likely to have 25(OH)D levels below 30 ng/mL. “Sometimes we think we're talking to the wall or ourselves, but these discussions actually may be having some kind of an impact,” Dr. Shoback said.

Other risk factors for vitamin D deficiency included age older than 80, a body mass index over 30 kg/m

Among patients with none of these risk factors, 32% had inadequate levels of 25(OH)D. “There just seem to be people out there who have vitamin D deficiency,” she said.

The 1998 inpatient study that detected vitamin D deficiency in 56% of 290 patients consecutively admitted to a hospital medical service also found that risk factors predicted the deficiency only about 60% of the time. The investigators recommended that medical inpatients be screened for vitamin D deficiency, she noted. Taking multivitamins did not prevent vitamin D deficiency in that study.

Dr. Shoback has no affiliation with companies that make vitamin D supplements.

SAN FRANCISCO — Physicians who see patients with osteoporosis should have a visual acuity chart on the office wall to check eyesight, Steven R. Cummings, M.D., advised at a meeting on osteoporosis sponsored by the University of California, San Francisco.

Reduced visual acuity greatly increases the risk for falling and hip fractures. Usually poor vision is due to treatable factors such as the need for an updated glasses prescription, or cataracts, said Dr. Cummings, professor emeritus of epidemiology and biostatistics at the university and director of clinical research at the California Pacific Medical Center Research Institute.

Impaired vision can double or quadruple the risk for hip fracture. At least one study shows that repairing cataracts can reduce the risk of falling by 34% (Br. J. Ophthalmol. 2005;89:53–9).

Dr. Cummings noted that the following additional risk factors are worth addressing to prevent fractures:

▸ Vertebral fracture. Having a vertebral fracture—even a painless, asymptomatic one that's detected only by x-ray—increases the risk for future vertebral fracture two- to fourfold. Older women with a previous vertebral fracture have a 1%–3% annual rate of hip fracture, and randomized trials suggest that pharmacologic treatment can lower that risk.

▸ Nonspine fractures. Having any kind of nonspine fracture nearly doubles or triples the risk for having a future nonspine fracture. This is especially true in men, and is independent of bone mineral density. Even with normal bone density, having a nonspine fracture makes a future nonspine fracture more likely.

▸ Familial history. People who had a parent develop a hip fracture have double the risk for hip fracture themselves, compared with people whose parents did not have hip fractures. This is true regardless of bone mineral density. A wrist fracture in a parent increases an offspring's risk of wrist fracture. “There's some suggestion that this increased familial risk may be specific to the type of fracture,” he said.

Studies have found no association, however, between patients' reports of parents who had osteoporosis or spine fractures and the patients' own risk for those problems, probably because “osteoporosis” and “spine fracture” are rather nonspecific terms used with different meanings.

▸ Weight. Women have a higher risk for serious fractures if they are losing weight involuntarily compared with maintaining or gaining weight. Involuntary weight loss is a marker for frailty. Fractures of the hip, humerus, spine or pelvis commonly are referred to as “frailty fractures,” he noted. Voluntary weight loss through diet or exercise diminishes a woman's bone mineral density, but it's not clear whether this increases fracture risk.

▸ Corticosteroid use. Taking more than 10 mg/day of prednisone or comparable doses of other corticosteroids reduces spinal bone density by 5%–10% in the first year, with most of the loss during the first 6 months. Higher doses of steroids reduce spinal bone density even more. Fracture risk increases even more quickly—within 1–2 months of starting corticosteroids. “There's a suggestion here that corticosteroids increase your risk for fractures in ways besides causing bone loss,” perhaps by killing osteocytes in bone and limiting the ability of bone to respond to stimulators, he said. Consider starting preventive therapy to prevent fractures if patients who will be taking steroids for at least several months have low bone densities or a history of fracture, Dr. Cummings suggested.

▸ Smoking. Cigarette smoking about doubles the risk for hip fracture regardless of a person's bone density, probably because smoking is associated with poorer health, weaker muscles, and impaired balance.

▸ Diabetes. Patients with diabetes have triple the risk for foot fractures and double the risk for humerus or hip fractures, compared with nondiabetic patients. If you see a patient with one of these fractures, look for diabetes, and watch for these fractures in patients already diagnosed with diabetes, he advised.

▸ Stroke. Patients who have had a stroke or are in nursing homes are at very high risk for hip fractures, warranting pharmacotherapy to preserve and strengthen bone. Each year 4%–6% of nursing home patients develop hip fractures. In patients over age 70 who have had a stroke, 3%–5% of women and 2% of men develop hip fractures per year.

SAN FRANCISCO — Physicians who see patients with osteoporosis should have a visual acuity chart on the office wall to check eyesight, Steven R. Cummings, M.D., advised at a meeting on osteoporosis sponsored by the University of California, San Francisco.

Reduced visual acuity greatly increases the risk for falling and hip fractures. Usually poor vision is due to treatable factors such as the need for an updated glasses prescription, or cataracts, said Dr. Cummings, professor emeritus of epidemiology and biostatistics at the university and director of clinical research at the California Pacific Medical Center Research Institute.

Impaired vision can double or quadruple the risk for hip fracture. At least one study shows that repairing cataracts can reduce the risk of falling by 34% (Br. J. Ophthalmol. 2005;89:53–9).

Dr. Cummings noted that the following additional risk factors are worth addressing to prevent fractures:

▸ Vertebral fracture. Having a vertebral fracture—even a painless, asymptomatic one that's detected only by x-ray—increases the risk for future vertebral fracture two- to fourfold. Older women with a previous vertebral fracture have a 1%–3% annual rate of hip fracture, and randomized trials suggest that pharmacologic treatment can lower that risk.

▸ Nonspine fractures. Having any kind of nonspine fracture nearly doubles or triples the risk for having a future nonspine fracture. This is especially true in men, and is independent of bone mineral density. Even with normal bone density, having a nonspine fracture makes a future nonspine fracture more likely.

▸ Familial history. People who had a parent develop a hip fracture have double the risk for hip fracture themselves, compared with people whose parents did not have hip fractures. This is true regardless of bone mineral density. A wrist fracture in a parent increases an offspring's risk of wrist fracture. “There's some suggestion that this increased familial risk may be specific to the type of fracture,” he said.

Studies have found no association, however, between patients' reports of parents who had osteoporosis or spine fractures and the patients' own risk for those problems, probably because “osteoporosis” and “spine fracture” are rather nonspecific terms used with different meanings.

▸ Weight. Women have a higher risk for serious fractures if they are losing weight involuntarily compared with maintaining or gaining weight. Involuntary weight loss is a marker for frailty. Fractures of the hip, humerus, spine or pelvis commonly are referred to as “frailty fractures,” he noted. Voluntary weight loss through diet or exercise diminishes a woman's bone mineral density, but it's not clear whether this increases fracture risk.

▸ Corticosteroid use. Taking more than 10 mg/day of prednisone or comparable doses of other corticosteroids reduces spinal bone density by 5%–10% in the first year, with most of the loss during the first 6 months. Higher doses of steroids reduce spinal bone density even more. Fracture risk increases even more quickly—within 1–2 months of starting corticosteroids. “There's a suggestion here that corticosteroids increase your risk for fractures in ways besides causing bone loss,” perhaps by killing osteocytes in bone and limiting the ability of bone to respond to stimulators, he said. Consider starting preventive therapy to prevent fractures if patients who will be taking steroids for at least several months have low bone densities or a history of fracture, Dr. Cummings suggested.

▸ Smoking. Cigarette smoking about doubles the risk for hip fracture regardless of a person's bone density, probably because smoking is associated with poorer health, weaker muscles, and impaired balance.

▸ Diabetes. Patients with diabetes have triple the risk for foot fractures and double the risk for humerus or hip fractures, compared with nondiabetic patients. If you see a patient with one of these fractures, look for diabetes, and watch for these fractures in patients already diagnosed with diabetes, he advised.

▸ Stroke. Patients who have had a stroke or are in nursing homes are at very high risk for hip fractures, warranting pharmacotherapy to preserve and strengthen bone. Each year 4%–6% of nursing home patients develop hip fractures. In patients over age 70 who have had a stroke, 3%–5% of women and 2% of men develop hip fractures per year.

SAN FRANCISCO — Physicians who see patients with osteoporosis should have a visual acuity chart on the office wall to check eyesight, Steven R. Cummings, M.D., advised at a meeting on osteoporosis sponsored by the University of California, San Francisco.

Reduced visual acuity greatly increases the risk for falling and hip fractures. Usually poor vision is due to treatable factors such as the need for an updated glasses prescription, or cataracts, said Dr. Cummings, professor emeritus of epidemiology and biostatistics at the university and director of clinical research at the California Pacific Medical Center Research Institute.

Impaired vision can double or quadruple the risk for hip fracture. At least one study shows that repairing cataracts can reduce the risk of falling by 34% (Br. J. Ophthalmol. 2005;89:53–9).

Dr. Cummings noted that the following additional risk factors are worth addressing to prevent fractures:

▸ Vertebral fracture. Having a vertebral fracture—even a painless, asymptomatic one that's detected only by x-ray—increases the risk for future vertebral fracture two- to fourfold. Older women with a previous vertebral fracture have a 1%–3% annual rate of hip fracture, and randomized trials suggest that pharmacologic treatment can lower that risk.

▸ Nonspine fractures. Having any kind of nonspine fracture nearly doubles or triples the risk for having a future nonspine fracture. This is especially true in men, and is independent of bone mineral density. Even with normal bone density, having a nonspine fracture makes a future nonspine fracture more likely.

▸ Familial history. People who had a parent develop a hip fracture have double the risk for hip fracture themselves, compared with people whose parents did not have hip fractures. This is true regardless of bone mineral density. A wrist fracture in a parent increases an offspring's risk of wrist fracture. “There's some suggestion that this increased familial risk may be specific to the type of fracture,” he said.

Studies have found no association, however, between patients' reports of parents who had osteoporosis or spine fractures and the patients' own risk for those problems, probably because “osteoporosis” and “spine fracture” are rather nonspecific terms used with different meanings.

▸ Weight. Women have a higher risk for serious fractures if they are losing weight involuntarily compared with maintaining or gaining weight. Involuntary weight loss is a marker for frailty. Fractures of the hip, humerus, spine or pelvis commonly are referred to as “frailty fractures,” he noted. Voluntary weight loss through diet or exercise diminishes a woman's bone mineral density, but it's not clear whether this increases fracture risk.

▸ Corticosteroid use. Taking more than 10 mg/day of prednisone or comparable doses of other corticosteroids reduces spinal bone density by 5%–10% in the first year, with most of the loss during the first 6 months. Higher doses of steroids reduce spinal bone density even more. Fracture risk increases even more quickly—within 1–2 months of starting corticosteroids. “There's a suggestion here that corticosteroids increase your risk for fractures in ways besides causing bone loss,” perhaps by killing osteocytes in bone and limiting the ability of bone to respond to stimulators, he said. Consider starting preventive therapy to prevent fractures if patients who will be taking steroids for at least several months have low bone densities or a history of fracture, Dr. Cummings suggested.

▸ Smoking. Cigarette smoking about doubles the risk for hip fracture regardless of a person's bone density, probably because smoking is associated with poorer health, weaker muscles, and impaired balance.

▸ Diabetes. Patients with diabetes have triple the risk for foot fractures and double the risk for humerus or hip fractures, compared with nondiabetic patients. If you see a patient with one of these fractures, look for diabetes, and watch for these fractures in patients already diagnosed with diabetes, he advised.

▸ Stroke. Patients who have had a stroke or are in nursing homes are at very high risk for hip fractures, warranting pharmacotherapy to preserve and strengthen bone. Each year 4%–6% of nursing home patients develop hip fractures. In patients over age 70 who have had a stroke, 3%–5% of women and 2% of men develop hip fractures per year.

VIENNA — Balloon kyphoplasty for vertebral compression fractures proved to be a safe and markedly more effective alternative to conservative management in a prospective 12-month comparative study, Arnd Lienert, M.D., Ph.D., said at the annual European congress of rheumatology.

He reported on 19 patients who underwent balloon kyphoplasty and 17 who opted instead for conservative management of monosegmental osteoporotic vertebral fractures in a nonrandomized study.

During 1 year of follow-up, 13 of 17 conservatively managed patients developed a total of 23 new radiographically proven vertebral fractures, of which 19 occurred adjacent to the index fracture. In contrast, only 8 of 19 balloon kyphoplasty patients developed 10 new fractures, of which 6 were in a vertebra next to the index fracture, said Dr. Lienert, an orthopedic surgeon at the University of Witten/Herdecke, Germany.

The balloon kyphoplasty group had significantly faster and greater reductions in pain and functional disability as assessed by a visual analog scale and a North American Spine Society questionnaire.

Moreover, their slumping due to spinal deformity was significantly less over time. Their pretreatment kyphotic angle of 34 degrees was reduced to 7 degrees at 1 year, compared with 19 degrees in the conservatively managed group, he added at the meeting sponsored by the European League Against Rheumatism.

There were no periprocedural complications associated with balloon kyphoplasty. The procedure restored vertebral compression fractures to more than 50% of the original vertebral height in all 19 treated patients, and to more than two-thirds of original height in 11 patients. All patients in the balloon kyphoplasty group indicated that they would be willing to undergo the procedure again if necessary.

Patients in both study arms received antiosteoporosis medication. Conservative management consisted of bracing, physical therapy, and nonsteroidal anti-inflammatory drugs.

Balloon kyphoplasty is a minimally invasive procedure in which the balloon inflation creates an intravertebral void that allows injection of high-viscosity bone cement to stabilize and reduce the fracture. A promising recent development involves the investigational use of a resorbable artificial bone scaffold capable of undergoing bone remodeling in lieu of the standard bone cement used in this study, according to the surgeon.

The best time to perform the procedure is still not known, and how well the results hold up beyond the 1-year mark also remains a question, Dr. Lienert observed.

The study was conducted by Dr. Lienert and his orthopedist colleagues at St. Anna Hospital in Herne, Germany, without outside sponsorship.

One audience member said he found it surprising that the incidence of adjacent fractures was significantly lower in the balloon kyphoplasty group than in conservatively managed patients given that some reports in the literature suggest balloon kyphoplasty might actually predispose patients to adjacent vertebral fractures. Dr. Lienert replied that he, too, is aware of such reports, adding that it's possible his findings to the contrary could simply be due to chance in a study with relatively small patient numbers.

Session cochair Winfried B. Graninger, M.D., a rheumatologist at the Medical University of Vienna, commented that a nonrandomized trial in which pain is a major end point is so methodologically problematic that he views it as “almost an uncontrolled study.”

Dr. Lienert responded that in his experience, it's much tougher to get patients to consent to randomization in studies involving surgical procedures than in drug trials.

VIENNA — Balloon kyphoplasty for vertebral compression fractures proved to be a safe and markedly more effective alternative to conservative management in a prospective 12-month comparative study, Arnd Lienert, M.D., Ph.D., said at the annual European congress of rheumatology.

He reported on 19 patients who underwent balloon kyphoplasty and 17 who opted instead for conservative management of monosegmental osteoporotic vertebral fractures in a nonrandomized study.

During 1 year of follow-up, 13 of 17 conservatively managed patients developed a total of 23 new radiographically proven vertebral fractures, of which 19 occurred adjacent to the index fracture. In contrast, only 8 of 19 balloon kyphoplasty patients developed 10 new fractures, of which 6 were in a vertebra next to the index fracture, said Dr. Lienert, an orthopedic surgeon at the University of Witten/Herdecke, Germany.

The balloon kyphoplasty group had significantly faster and greater reductions in pain and functional disability as assessed by a visual analog scale and a North American Spine Society questionnaire.

Moreover, their slumping due to spinal deformity was significantly less over time. Their pretreatment kyphotic angle of 34 degrees was reduced to 7 degrees at 1 year, compared with 19 degrees in the conservatively managed group, he added at the meeting sponsored by the European League Against Rheumatism.

There were no periprocedural complications associated with balloon kyphoplasty. The procedure restored vertebral compression fractures to more than 50% of the original vertebral height in all 19 treated patients, and to more than two-thirds of original height in 11 patients. All patients in the balloon kyphoplasty group indicated that they would be willing to undergo the procedure again if necessary.

Patients in both study arms received antiosteoporosis medication. Conservative management consisted of bracing, physical therapy, and nonsteroidal anti-inflammatory drugs.

Balloon kyphoplasty is a minimally invasive procedure in which the balloon inflation creates an intravertebral void that allows injection of high-viscosity bone cement to stabilize and reduce the fracture. A promising recent development involves the investigational use of a resorbable artificial bone scaffold capable of undergoing bone remodeling in lieu of the standard bone cement used in this study, according to the surgeon.

The best time to perform the procedure is still not known, and how well the results hold up beyond the 1-year mark also remains a question, Dr. Lienert observed.

The study was conducted by Dr. Lienert and his orthopedist colleagues at St. Anna Hospital in Herne, Germany, without outside sponsorship.

One audience member said he found it surprising that the incidence of adjacent fractures was significantly lower in the balloon kyphoplasty group than in conservatively managed patients given that some reports in the literature suggest balloon kyphoplasty might actually predispose patients to adjacent vertebral fractures. Dr. Lienert replied that he, too, is aware of such reports, adding that it's possible his findings to the contrary could simply be due to chance in a study with relatively small patient numbers.

Session cochair Winfried B. Graninger, M.D., a rheumatologist at the Medical University of Vienna, commented that a nonrandomized trial in which pain is a major end point is so methodologically problematic that he views it as “almost an uncontrolled study.”

Dr. Lienert responded that in his experience, it's much tougher to get patients to consent to randomization in studies involving surgical procedures than in drug trials.

VIENNA — Balloon kyphoplasty for vertebral compression fractures proved to be a safe and markedly more effective alternative to conservative management in a prospective 12-month comparative study, Arnd Lienert, M.D., Ph.D., said at the annual European congress of rheumatology.

He reported on 19 patients who underwent balloon kyphoplasty and 17 who opted instead for conservative management of monosegmental osteoporotic vertebral fractures in a nonrandomized study.

During 1 year of follow-up, 13 of 17 conservatively managed patients developed a total of 23 new radiographically proven vertebral fractures, of which 19 occurred adjacent to the index fracture. In contrast, only 8 of 19 balloon kyphoplasty patients developed 10 new fractures, of which 6 were in a vertebra next to the index fracture, said Dr. Lienert, an orthopedic surgeon at the University of Witten/Herdecke, Germany.

The balloon kyphoplasty group had significantly faster and greater reductions in pain and functional disability as assessed by a visual analog scale and a North American Spine Society questionnaire.

Moreover, their slumping due to spinal deformity was significantly less over time. Their pretreatment kyphotic angle of 34 degrees was reduced to 7 degrees at 1 year, compared with 19 degrees in the conservatively managed group, he added at the meeting sponsored by the European League Against Rheumatism.

There were no periprocedural complications associated with balloon kyphoplasty. The procedure restored vertebral compression fractures to more than 50% of the original vertebral height in all 19 treated patients, and to more than two-thirds of original height in 11 patients. All patients in the balloon kyphoplasty group indicated that they would be willing to undergo the procedure again if necessary.

Patients in both study arms received antiosteoporosis medication. Conservative management consisted of bracing, physical therapy, and nonsteroidal anti-inflammatory drugs.

Balloon kyphoplasty is a minimally invasive procedure in which the balloon inflation creates an intravertebral void that allows injection of high-viscosity bone cement to stabilize and reduce the fracture. A promising recent development involves the investigational use of a resorbable artificial bone scaffold capable of undergoing bone remodeling in lieu of the standard bone cement used in this study, according to the surgeon.

The best time to perform the procedure is still not known, and how well the results hold up beyond the 1-year mark also remains a question, Dr. Lienert observed.

The study was conducted by Dr. Lienert and his orthopedist colleagues at St. Anna Hospital in Herne, Germany, without outside sponsorship.

One audience member said he found it surprising that the incidence of adjacent fractures was significantly lower in the balloon kyphoplasty group than in conservatively managed patients given that some reports in the literature suggest balloon kyphoplasty might actually predispose patients to adjacent vertebral fractures. Dr. Lienert replied that he, too, is aware of such reports, adding that it's possible his findings to the contrary could simply be due to chance in a study with relatively small patient numbers.

Session cochair Winfried B. Graninger, M.D., a rheumatologist at the Medical University of Vienna, commented that a nonrandomized trial in which pain is a major end point is so methodologically problematic that he views it as “almost an uncontrolled study.”

Dr. Lienert responded that in his experience, it's much tougher to get patients to consent to randomization in studies involving surgical procedures than in drug trials.

VIENNA — Alendronate is markedly more effective than 1-hydroxyvitamin D₃ (alfacalcidol) as prophylaxis against glucocorticoid-induced osteoporosis, Johannes W.J. Bijlsma, M.D., Ph.D., said at the annual European congress of rheumatology.

He reported on 200 patients—40% men, the rest postmenopausal women—in an 18-month randomized double-blind 23-center Dutch trial sponsored by the Netherlands Health Council.

Participants had various rheumatic diseases for which they were placed on systemic steroids at a mean starting dose of 23 mg/day of prednisolone or its equivalent. Over 18 months their cumulative dose was nearly 6 g.

Patients were randomized at the outset of steroid therapy to 10 mg/day of alendronate plus placebo or 1 mcg/day of alfacalcidol, an activated vitamin D, plus placebo.

The primary study end point was change in lumbar spine bone mineral density over the 18 months.

It increased by 2.3% in the alendronate group and decreased by 1.9% in the alfacalcidol group, for a net 4.2% difference between the regimens.

Similarly, total hip bone mineral density increased by 0.7% in the alendronate group while declining by 2.5% with alfacalcidol, said Dr. Bijlsma, professor and head of the department of rheumatology and clinical immunology at University Medical Center, Utrecht, the Netherlands.

Three asymptomatic vertebral fractures occurred in three patients in the alendronate group, compared with 13 vertebral fractures in eight patients in the alfacalcidol group; 5 of them were in three patients who were symptomatic.

Glucocorticoid-induced osteoporosis is an enormous problem. In various epidemiologic studies 0.5%–1.7% of women over the age of 55 are on prolonged systemic steroid therapy. Fifty percent develop osteoporosis. One-third experience vertebral fractures. Marked trabecular bone loss, mainly due to reduced bone formation, is observed within the first 6 months of steroid therapy.

Steroids decrease osteoblasts, reducing bone formation, and encourage release of parathyroid hormone, stimulating bone resorption. Bisphosphonates are known to protect against steroid-induced osteoporosis, Dr. Bijlsma said.

Alfacalcidol was deemed worth studying as an alternative because activated vitamin D stimulates osteoblasts, thereby encouraging bone formation, he explained at the meeting, sponsored by the European League Against Rheumatism.

VIENNA — Alendronate is markedly more effective than 1-hydroxyvitamin D₃ (alfacalcidol) as prophylaxis against glucocorticoid-induced osteoporosis, Johannes W.J. Bijlsma, M.D., Ph.D., said at the annual European congress of rheumatology.

He reported on 200 patients—40% men, the rest postmenopausal women—in an 18-month randomized double-blind 23-center Dutch trial sponsored by the Netherlands Health Council.

Participants had various rheumatic diseases for which they were placed on systemic steroids at a mean starting dose of 23 mg/day of prednisolone or its equivalent. Over 18 months their cumulative dose was nearly 6 g.

Patients were randomized at the outset of steroid therapy to 10 mg/day of alendronate plus placebo or 1 mcg/day of alfacalcidol, an activated vitamin D, plus placebo.

The primary study end point was change in lumbar spine bone mineral density over the 18 months.

It increased by 2.3% in the alendronate group and decreased by 1.9% in the alfacalcidol group, for a net 4.2% difference between the regimens.

Similarly, total hip bone mineral density increased by 0.7% in the alendronate group while declining by 2.5% with alfacalcidol, said Dr. Bijlsma, professor and head of the department of rheumatology and clinical immunology at University Medical Center, Utrecht, the Netherlands.

Three asymptomatic vertebral fractures occurred in three patients in the alendronate group, compared with 13 vertebral fractures in eight patients in the alfacalcidol group; 5 of them were in three patients who were symptomatic.

Glucocorticoid-induced osteoporosis is an enormous problem. In various epidemiologic studies 0.5%–1.7% of women over the age of 55 are on prolonged systemic steroid therapy. Fifty percent develop osteoporosis. One-third experience vertebral fractures. Marked trabecular bone loss, mainly due to reduced bone formation, is observed within the first 6 months of steroid therapy.

Steroids decrease osteoblasts, reducing bone formation, and encourage release of parathyroid hormone, stimulating bone resorption. Bisphosphonates are known to protect against steroid-induced osteoporosis, Dr. Bijlsma said.

Alfacalcidol was deemed worth studying as an alternative because activated vitamin D stimulates osteoblasts, thereby encouraging bone formation, he explained at the meeting, sponsored by the European League Against Rheumatism.

VIENNA — Alendronate is markedly more effective than 1-hydroxyvitamin D₃ (alfacalcidol) as prophylaxis against glucocorticoid-induced osteoporosis, Johannes W.J. Bijlsma, M.D., Ph.D., said at the annual European congress of rheumatology.

He reported on 200 patients—40% men, the rest postmenopausal women—in an 18-month randomized double-blind 23-center Dutch trial sponsored by the Netherlands Health Council.

Participants had various rheumatic diseases for which they were placed on systemic steroids at a mean starting dose of 23 mg/day of prednisolone or its equivalent. Over 18 months their cumulative dose was nearly 6 g.

Patients were randomized at the outset of steroid therapy to 10 mg/day of alendronate plus placebo or 1 mcg/day of alfacalcidol, an activated vitamin D, plus placebo.

The primary study end point was change in lumbar spine bone mineral density over the 18 months.

It increased by 2.3% in the alendronate group and decreased by 1.9% in the alfacalcidol group, for a net 4.2% difference between the regimens.

Similarly, total hip bone mineral density increased by 0.7% in the alendronate group while declining by 2.5% with alfacalcidol, said Dr. Bijlsma, professor and head of the department of rheumatology and clinical immunology at University Medical Center, Utrecht, the Netherlands.

Three asymptomatic vertebral fractures occurred in three patients in the alendronate group, compared with 13 vertebral fractures in eight patients in the alfacalcidol group; 5 of them were in three patients who were symptomatic.

Glucocorticoid-induced osteoporosis is an enormous problem. In various epidemiologic studies 0.5%–1.7% of women over the age of 55 are on prolonged systemic steroid therapy. Fifty percent develop osteoporosis. One-third experience vertebral fractures. Marked trabecular bone loss, mainly due to reduced bone formation, is observed within the first 6 months of steroid therapy.

Steroids decrease osteoblasts, reducing bone formation, and encourage release of parathyroid hormone, stimulating bone resorption. Bisphosphonates are known to protect against steroid-induced osteoporosis, Dr. Bijlsma said.

Alfacalcidol was deemed worth studying as an alternative because activated vitamin D stimulates osteoblasts, thereby encouraging bone formation, he explained at the meeting, sponsored by the European League Against Rheumatism.

SANTA BARBARA, CALIF. — About half of patients using glucocorticoids for long periods will suffer compression fractures of the vertebrae if nothing is done to intervene, Barbara P. Lukert, M.D., said at a symposium sponsored by the American College of Rheumatology.

Bisphosphonate therapy is clearly effective in reducing fractures, whether started when initiating glucocorticoids or after a patient has been on them for a while. But bisphosphonates aren't enough, and other steps should be taken to manage these patients, said Dr. Lukert of the University of Kansas Medical Center in Kansas City.

Other opportunities to intervene include:

▸ Diet is critical. Since glucocorticoids are catabolic, patients need adequate protein intake, not just calcium and phosphorus.

▸ Heavily encourage patients to exercise, not only because of its benefits on bone. Glucocorticoids often cause myopathy, ranging from mild to severe, and exercise can stave this off. Strengthening the quadriceps and related muscle groups has been shown to prevent falls.

▸ Control urinary calcium. A very large percentage of patients on glucocorticoids will develop hypercalciuria, and restricting sodium in the diet will go a long way toward resolving this.

▸ Replace hormones as appropriate. Glucocorticoids inhibit pituitary gonadotropin, and men taking steroids often have low testosterone levels. If there's no contraindication, this testosterone should be replaced, Dr. Lukert said.

Women taking steroids often have low estrogen levels. If premenopausal women become amenorrheic on glucocorticoids, consider prescribing estrogen or progesterone. Dr. Lukert noted that estrogen replacement in postmenopausal women remains controversial.

Patients who have a bone mineral density (BMD) T score of less than −1.5 or are taking more than 10 mg/day of prednisone or the equivalent should receive bisphosphonate therapy as soon as corticosteroids are started.

Patients with a higher BMD taking lower doses of prednisone may hold off on starting bisphosphonate therapy at first and retest BMD after 6 months.

Another reasonable strategy is simply to give a bisphosphonate to all patients who anticipate taking steroids for several weeks or longer.

This strategy is certain to prevent fractures, but at the cost of treating 40%–50% of patients who would not have suffered a fracture even without the bisphosphonate prescription, Dr. Lukert said.

SANTA BARBARA, CALIF. — About half of patients using glucocorticoids for long periods will suffer compression fractures of the vertebrae if nothing is done to intervene, Barbara P. Lukert, M.D., said at a symposium sponsored by the American College of Rheumatology.

Bisphosphonate therapy is clearly effective in reducing fractures, whether started when initiating glucocorticoids or after a patient has been on them for a while. But bisphosphonates aren't enough, and other steps should be taken to manage these patients, said Dr. Lukert of the University of Kansas Medical Center in Kansas City.

Other opportunities to intervene include:

▸ Diet is critical. Since glucocorticoids are catabolic, patients need adequate protein intake, not just calcium and phosphorus.

▸ Heavily encourage patients to exercise, not only because of its benefits on bone. Glucocorticoids often cause myopathy, ranging from mild to severe, and exercise can stave this off. Strengthening the quadriceps and related muscle groups has been shown to prevent falls.

▸ Control urinary calcium. A very large percentage of patients on glucocorticoids will develop hypercalciuria, and restricting sodium in the diet will go a long way toward resolving this.

▸ Replace hormones as appropriate. Glucocorticoids inhibit pituitary gonadotropin, and men taking steroids often have low testosterone levels. If there's no contraindication, this testosterone should be replaced, Dr. Lukert said.

Women taking steroids often have low estrogen levels. If premenopausal women become amenorrheic on glucocorticoids, consider prescribing estrogen or progesterone. Dr. Lukert noted that estrogen replacement in postmenopausal women remains controversial.

Patients who have a bone mineral density (BMD) T score of less than −1.5 or are taking more than 10 mg/day of prednisone or the equivalent should receive bisphosphonate therapy as soon as corticosteroids are started.

Patients with a higher BMD taking lower doses of prednisone may hold off on starting bisphosphonate therapy at first and retest BMD after 6 months.

Another reasonable strategy is simply to give a bisphosphonate to all patients who anticipate taking steroids for several weeks or longer.

This strategy is certain to prevent fractures, but at the cost of treating 40%–50% of patients who would not have suffered a fracture even without the bisphosphonate prescription, Dr. Lukert said.

SANTA BARBARA, CALIF. — About half of patients using glucocorticoids for long periods will suffer compression fractures of the vertebrae if nothing is done to intervene, Barbara P. Lukert, M.D., said at a symposium sponsored by the American College of Rheumatology.

Bisphosphonate therapy is clearly effective in reducing fractures, whether started when initiating glucocorticoids or after a patient has been on them for a while. But bisphosphonates aren't enough, and other steps should be taken to manage these patients, said Dr. Lukert of the University of Kansas Medical Center in Kansas City.

Other opportunities to intervene include:

▸ Diet is critical. Since glucocorticoids are catabolic, patients need adequate protein intake, not just calcium and phosphorus.

▸ Heavily encourage patients to exercise, not only because of its benefits on bone. Glucocorticoids often cause myopathy, ranging from mild to severe, and exercise can stave this off. Strengthening the quadriceps and related muscle groups has been shown to prevent falls.

▸ Control urinary calcium. A very large percentage of patients on glucocorticoids will develop hypercalciuria, and restricting sodium in the diet will go a long way toward resolving this.

▸ Replace hormones as appropriate. Glucocorticoids inhibit pituitary gonadotropin, and men taking steroids often have low testosterone levels. If there's no contraindication, this testosterone should be replaced, Dr. Lukert said.

Women taking steroids often have low estrogen levels. If premenopausal women become amenorrheic on glucocorticoids, consider prescribing estrogen or progesterone. Dr. Lukert noted that estrogen replacement in postmenopausal women remains controversial.

Patients who have a bone mineral density (BMD) T score of less than −1.5 or are taking more than 10 mg/day of prednisone or the equivalent should receive bisphosphonate therapy as soon as corticosteroids are started.

Patients with a higher BMD taking lower doses of prednisone may hold off on starting bisphosphonate therapy at first and retest BMD after 6 months.

Another reasonable strategy is simply to give a bisphosphonate to all patients who anticipate taking steroids for several weeks or longer.

This strategy is certain to prevent fractures, but at the cost of treating 40%–50% of patients who would not have suffered a fracture even without the bisphosphonate prescription, Dr. Lukert said.

VIENNA — Oral ibandronate at 150 mg once monthly showed continued impressive therapeutic efficacy in women with postmenopausal osteoporosis at the 2-year mark in the Monthly Oral Ibandronate in Ladies (MOBILE) trial, Pierre D. Delmas, M.D., said at the annual European congress of rheumatology.

Ibandronate (Boniva) was approved by the Food and Drug Administration this spring as the first once-monthly oral bisphosphonate, in part because of the persuasive 1-year results of MOBILE. The new 2-year data provide reassurance that over the longer term this therapy continues to be a highly effective and well-tolerated alternative to daily or weekly bisphosphonates, said Dr. Delmas, professor of medicine and rheumatology at Claude Bernard University, Lyon, France.

MOBILE is a randomized, double-blind, phase III, Roche- and GlaxoSmithKline-sponsored clinical trial involving 1,609 women with postmenopausal osteoporosis who were placed on oral ibandronate at 2.5 mg/day, 100 mg once per month, 150 mg once per month, or 50 mg on each of two consecutive days per month. The daily-therapy arm served as the comparator group in this trial because 2.5 mg/day was the first FDA-approved ibandronate regimen, and it was previously shown to reduce vertebral fracture risk by 62% compared with placebo in a 3-year trial. Dr. Delmas focused on the once-monthly 150-mg group because this dosage showed the greatest efficacy and is already approved in the United States.

MOBILE wasn't designed or powered to evaluate fracture risk. It was a bridging trial that relied upon the surrogate end points of change in bone mineral density (BMD) and bone resorption markers in an effort to establish that monthly therapy was noninferior to the 2.5-mg/day regimen. In fact, the 150-mg once-monthly regimen proved to be superior to daily therapy in terms of improvement in BMD at various sites at 2 years. (See chart.)

The mean decrease in the bone resorption marker serum C-terminal cross-linking telopeptide of type I collagen (sCTX) was 67.7% in the 150-mg once-monthly group and 61.5% with daily therapy. Tolerability and the incidence of side effects in all of the once-monthly study arms at 2 years were similar to rates with daily therapy, as was also true after 1 year, Dr. Delmas said at the meeting, which was sponsored by the European League Against Rheumatism.

MOBILE coinvestigator Jean-Yves Reginster, M.D., said it's a reasonable hypothesis that once-monthly therapy will result in better therapeutic adherence than weekly or daily therapy, as 1-year adherence to bisphosphonate therapy has been shown to be nearly twice as great with weekly versus daily treatment. This hypothesis is supported by data from a large new European patient survey indicating that four-fifths of women with postmenopausal osteoporosis would be interested in dosing regimens that are less frequent than weekly, and three-fourths of physicians believe that such regimens would have a strong favorable effect upon adherence.

“We're now facing a new challenge in the management of osteoporosis: It's that bisphosphonate compliance and persistence with daily or weekly regimens remain largely suboptimal. More than one-half of patients don't even take their drug for 12 months,” according to Dr. Reginster of the University of Liège, Belgium.

VIENNA — Oral ibandronate at 150 mg once monthly showed continued impressive therapeutic efficacy in women with postmenopausal osteoporosis at the 2-year mark in the Monthly Oral Ibandronate in Ladies (MOBILE) trial, Pierre D. Delmas, M.D., said at the annual European congress of rheumatology.

Ibandronate (Boniva) was approved by the Food and Drug Administration this spring as the first once-monthly oral bisphosphonate, in part because of the persuasive 1-year results of MOBILE. The new 2-year data provide reassurance that over the longer term this therapy continues to be a highly effective and well-tolerated alternative to daily or weekly bisphosphonates, said Dr. Delmas, professor of medicine and rheumatology at Claude Bernard University, Lyon, France.

MOBILE is a randomized, double-blind, phase III, Roche- and GlaxoSmithKline-sponsored clinical trial involving 1,609 women with postmenopausal osteoporosis who were placed on oral ibandronate at 2.5 mg/day, 100 mg once per month, 150 mg once per month, or 50 mg on each of two consecutive days per month. The daily-therapy arm served as the comparator group in this trial because 2.5 mg/day was the first FDA-approved ibandronate regimen, and it was previously shown to reduce vertebral fracture risk by 62% compared with placebo in a 3-year trial. Dr. Delmas focused on the once-monthly 150-mg group because this dosage showed the greatest efficacy and is already approved in the United States.

MOBILE wasn't designed or powered to evaluate fracture risk. It was a bridging trial that relied upon the surrogate end points of change in bone mineral density (BMD) and bone resorption markers in an effort to establish that monthly therapy was noninferior to the 2.5-mg/day regimen. In fact, the 150-mg once-monthly regimen proved to be superior to daily therapy in terms of improvement in BMD at various sites at 2 years. (See chart.)

The mean decrease in the bone resorption marker serum C-terminal cross-linking telopeptide of type I collagen (sCTX) was 67.7% in the 150-mg once-monthly group and 61.5% with daily therapy. Tolerability and the incidence of side effects in all of the once-monthly study arms at 2 years were similar to rates with daily therapy, as was also true after 1 year, Dr. Delmas said at the meeting, which was sponsored by the European League Against Rheumatism.

MOBILE coinvestigator Jean-Yves Reginster, M.D., said it's a reasonable hypothesis that once-monthly therapy will result in better therapeutic adherence than weekly or daily therapy, as 1-year adherence to bisphosphonate therapy has been shown to be nearly twice as great with weekly versus daily treatment. This hypothesis is supported by data from a large new European patient survey indicating that four-fifths of women with postmenopausal osteoporosis would be interested in dosing regimens that are less frequent than weekly, and three-fourths of physicians believe that such regimens would have a strong favorable effect upon adherence.

“We're now facing a new challenge in the management of osteoporosis: It's that bisphosphonate compliance and persistence with daily or weekly regimens remain largely suboptimal. More than one-half of patients don't even take their drug for 12 months,” according to Dr. Reginster of the University of Liège, Belgium.

VIENNA — Oral ibandronate at 150 mg once monthly showed continued impressive therapeutic efficacy in women with postmenopausal osteoporosis at the 2-year mark in the Monthly Oral Ibandronate in Ladies (MOBILE) trial, Pierre D. Delmas, M.D., said at the annual European congress of rheumatology.

Ibandronate (Boniva) was approved by the Food and Drug Administration this spring as the first once-monthly oral bisphosphonate, in part because of the persuasive 1-year results of MOBILE. The new 2-year data provide reassurance that over the longer term this therapy continues to be a highly effective and well-tolerated alternative to daily or weekly bisphosphonates, said Dr. Delmas, professor of medicine and rheumatology at Claude Bernard University, Lyon, France.

MOBILE is a randomized, double-blind, phase III, Roche- and GlaxoSmithKline-sponsored clinical trial involving 1,609 women with postmenopausal osteoporosis who were placed on oral ibandronate at 2.5 mg/day, 100 mg once per month, 150 mg once per month, or 50 mg on each of two consecutive days per month. The daily-therapy arm served as the comparator group in this trial because 2.5 mg/day was the first FDA-approved ibandronate regimen, and it was previously shown to reduce vertebral fracture risk by 62% compared with placebo in a 3-year trial. Dr. Delmas focused on the once-monthly 150-mg group because this dosage showed the greatest efficacy and is already approved in the United States.

MOBILE wasn't designed or powered to evaluate fracture risk. It was a bridging trial that relied upon the surrogate end points of change in bone mineral density (BMD) and bone resorption markers in an effort to establish that monthly therapy was noninferior to the 2.5-mg/day regimen. In fact, the 150-mg once-monthly regimen proved to be superior to daily therapy in terms of improvement in BMD at various sites at 2 years. (See chart.)

The mean decrease in the bone resorption marker serum C-terminal cross-linking telopeptide of type I collagen (sCTX) was 67.7% in the 150-mg once-monthly group and 61.5% with daily therapy. Tolerability and the incidence of side effects in all of the once-monthly study arms at 2 years were similar to rates with daily therapy, as was also true after 1 year, Dr. Delmas said at the meeting, which was sponsored by the European League Against Rheumatism.

MOBILE coinvestigator Jean-Yves Reginster, M.D., said it's a reasonable hypothesis that once-monthly therapy will result in better therapeutic adherence than weekly or daily therapy, as 1-year adherence to bisphosphonate therapy has been shown to be nearly twice as great with weekly versus daily treatment. This hypothesis is supported by data from a large new European patient survey indicating that four-fifths of women with postmenopausal osteoporosis would be interested in dosing regimens that are less frequent than weekly, and three-fourths of physicians believe that such regimens would have a strong favorable effect upon adherence.

“We're now facing a new challenge in the management of osteoporosis: It's that bisphosphonate compliance and persistence with daily or weekly regimens remain largely suboptimal. More than one-half of patients don't even take their drug for 12 months,” according to Dr. Reginster of the University of Liège, Belgium.

WASHINGTON — More than half of North American women receiving treatment for osteoporosis have suboptimal serum vitamin D levels, Anne E. de Papp, M.D., and her associates reported in a poster at the annual meeting of the American Association of Clinical Endocrinologists.

Inadequate vitamin D concentrations can lead to alterations in calcium and phosphate homeostasis, secondary hypoparathyroidism, bone loss, osteoporosis, and an increased risk of fractures.

Yet data from a cross-sectional study of 1,536 postmenopausal women seen at 61 North American sites suggest that the problem is often overlooked in patients being treated for osteoporosis, said Dr. de Papp, of Merck & Co. Inc., West Point, Pa., and her associates.

The patients had a mean age of 71 years (range, 47–103 years) and a mean body mass index (BMI) of 26.4 kg/m

Vitamin D supplementation at a dosage of 400 IU/day or more was reported by 59.5% of the women, while the rest were taking less.

For the entire group, the mean serum level of the active vitamin D metabolite 25-hydroxyvitamin D was 30.4 ng/mL. Most of the women (52%) had levels below 30 ng/mL, considered the minimum concentration necessary to maintain optimal serum parathyroid hormone levels (Osteoporos Int. 1997;7:439–43), while 36% had 25-hydroxyvitamin D levels below 25 ng/mL, and 18% were below 20 ng/mL, the investigators reported.

Suboptimal 25-hydroxyvitamin D concentrations were found in 63% of women taking less than 400 IU/day of vitamin D, compared with 45% of those receiving 400 IU or more per day.

The study was funded by Merck.

WASHINGTON — More than half of North American women receiving treatment for osteoporosis have suboptimal serum vitamin D levels, Anne E. de Papp, M.D., and her associates reported in a poster at the annual meeting of the American Association of Clinical Endocrinologists.

Inadequate vitamin D concentrations can lead to alterations in calcium and phosphate homeostasis, secondary hypoparathyroidism, bone loss, osteoporosis, and an increased risk of fractures.

Yet data from a cross-sectional study of 1,536 postmenopausal women seen at 61 North American sites suggest that the problem is often overlooked in patients being treated for osteoporosis, said Dr. de Papp, of Merck & Co. Inc., West Point, Pa., and her associates.

The patients had a mean age of 71 years (range, 47–103 years) and a mean body mass index (BMI) of 26.4 kg/m

Vitamin D supplementation at a dosage of 400 IU/day or more was reported by 59.5% of the women, while the rest were taking less.

For the entire group, the mean serum level of the active vitamin D metabolite 25-hydroxyvitamin D was 30.4 ng/mL. Most of the women (52%) had levels below 30 ng/mL, considered the minimum concentration necessary to maintain optimal serum parathyroid hormone levels (Osteoporos Int. 1997;7:439–43), while 36% had 25-hydroxyvitamin D levels below 25 ng/mL, and 18% were below 20 ng/mL, the investigators reported.

Suboptimal 25-hydroxyvitamin D concentrations were found in 63% of women taking less than 400 IU/day of vitamin D, compared with 45% of those receiving 400 IU or more per day.

The study was funded by Merck.

WASHINGTON — More than half of North American women receiving treatment for osteoporosis have suboptimal serum vitamin D levels, Anne E. de Papp, M.D., and her associates reported in a poster at the annual meeting of the American Association of Clinical Endocrinologists.

Inadequate vitamin D concentrations can lead to alterations in calcium and phosphate homeostasis, secondary hypoparathyroidism, bone loss, osteoporosis, and an increased risk of fractures.

Yet data from a cross-sectional study of 1,536 postmenopausal women seen at 61 North American sites suggest that the problem is often overlooked in patients being treated for osteoporosis, said Dr. de Papp, of Merck & Co. Inc., West Point, Pa., and her associates.

The patients had a mean age of 71 years (range, 47–103 years) and a mean body mass index (BMI) of 26.4 kg/m

Vitamin D supplementation at a dosage of 400 IU/day or more was reported by 59.5% of the women, while the rest were taking less.

For the entire group, the mean serum level of the active vitamin D metabolite 25-hydroxyvitamin D was 30.4 ng/mL. Most of the women (52%) had levels below 30 ng/mL, considered the minimum concentration necessary to maintain optimal serum parathyroid hormone levels (Osteoporos Int. 1997;7:439–43), while 36% had 25-hydroxyvitamin D levels below 25 ng/mL, and 18% were below 20 ng/mL, the investigators reported.

Suboptimal 25-hydroxyvitamin D concentrations were found in 63% of women taking less than 400 IU/day of vitamin D, compared with 45% of those receiving 400 IU or more per day.

The study was funded by Merck.

WASHINGTON — A serum 25-hydroxyvitamin D level below 30 ng/mL appears to define vitamin D deficiency, Paraskevi Sapountzi, M.D., reported at the annual meeting of the American Association of Clinical Endocrinologists.

Vitamin D deficiency, which is highly prevalent among patients with osteoporosis, can lead to a poor response to therapy. But recent reports of assay variability have led to confusion about interpretation of the metabolite 25(OH)D levels, and not enough data are available to guide clinicians regarding when to initiate vitamin D therapy, said Dr. Sapountzi, of Loyola University, Chicago.

In a retrospective analysis of 143 female and 20 male patients who had been evaluated for low bone mass at the university's Osteoporosis and Metabolic Bone Disease Center, the patients had a mean age of 62.5 years, a mean 25(OH)D level of 29.8 ng/mL, a mean parathyroid hormone (PTH) level of 61.7 pg/mL, a mean urine calcium level of 215.7 mg/24 hours, and a mean spine T score of −1.9. None of the subjects were on vitamin D therapy or had primary hyperparathyroidism, she said.

Initially, vitamin D insufficiency was defined as a 25(OH)D level of less than 20 ng/mL, based on the lab's reference range and data from one study suggesting that this was the cutoff below which the risk for secondary hyperparathyroidism increases. With that definition, 26.4% of the 163 patients had vitamin D insufficiency.

The 25(OH)D level was significantly correlated with PTH and with urinary calcium, with the difference between the means of PTH above and below a 25(OH)D level of 30 ng/mL being significant. At 35 ng/mL, the significance was lost. Using the new cutoff of 30 ng/mL for vitamin D deficiency raised the prevalence among the subjects to 48%, Dr. Sapountzi reported.

A 25(OH)D level of 30 ng/mL also showed significant differences in the urinary calcium levels of patients with 25(OH)D above and below that threshold.

WASHINGTON — A serum 25-hydroxyvitamin D level below 30 ng/mL appears to define vitamin D deficiency, Paraskevi Sapountzi, M.D., reported at the annual meeting of the American Association of Clinical Endocrinologists.

Vitamin D deficiency, which is highly prevalent among patients with osteoporosis, can lead to a poor response to therapy. But recent reports of assay variability have led to confusion about interpretation of the metabolite 25(OH)D levels, and not enough data are available to guide clinicians regarding when to initiate vitamin D therapy, said Dr. Sapountzi, of Loyola University, Chicago.

In a retrospective analysis of 143 female and 20 male patients who had been evaluated for low bone mass at the university's Osteoporosis and Metabolic Bone Disease Center, the patients had a mean age of 62.5 years, a mean 25(OH)D level of 29.8 ng/mL, a mean parathyroid hormone (PTH) level of 61.7 pg/mL, a mean urine calcium level of 215.7 mg/24 hours, and a mean spine T score of −1.9. None of the subjects were on vitamin D therapy or had primary hyperparathyroidism, she said.

Initially, vitamin D insufficiency was defined as a 25(OH)D level of less than 20 ng/mL, based on the lab's reference range and data from one study suggesting that this was the cutoff below which the risk for secondary hyperparathyroidism increases. With that definition, 26.4% of the 163 patients had vitamin D insufficiency.

The 25(OH)D level was significantly correlated with PTH and with urinary calcium, with the difference between the means of PTH above and below a 25(OH)D level of 30 ng/mL being significant. At 35 ng/mL, the significance was lost. Using the new cutoff of 30 ng/mL for vitamin D deficiency raised the prevalence among the subjects to 48%, Dr. Sapountzi reported.

A 25(OH)D level of 30 ng/mL also showed significant differences in the urinary calcium levels of patients with 25(OH)D above and below that threshold.

WASHINGTON — A serum 25-hydroxyvitamin D level below 30 ng/mL appears to define vitamin D deficiency, Paraskevi Sapountzi, M.D., reported at the annual meeting of the American Association of Clinical Endocrinologists.

Vitamin D deficiency, which is highly prevalent among patients with osteoporosis, can lead to a poor response to therapy. But recent reports of assay variability have led to confusion about interpretation of the metabolite 25(OH)D levels, and not enough data are available to guide clinicians regarding when to initiate vitamin D therapy, said Dr. Sapountzi, of Loyola University, Chicago.

In a retrospective analysis of 143 female and 20 male patients who had been evaluated for low bone mass at the university's Osteoporosis and Metabolic Bone Disease Center, the patients had a mean age of 62.5 years, a mean 25(OH)D level of 29.8 ng/mL, a mean parathyroid hormone (PTH) level of 61.7 pg/mL, a mean urine calcium level of 215.7 mg/24 hours, and a mean spine T score of −1.9. None of the subjects were on vitamin D therapy or had primary hyperparathyroidism, she said.

Initially, vitamin D insufficiency was defined as a 25(OH)D level of less than 20 ng/mL, based on the lab's reference range and data from one study suggesting that this was the cutoff below which the risk for secondary hyperparathyroidism increases. With that definition, 26.4% of the 163 patients had vitamin D insufficiency.

The 25(OH)D level was significantly correlated with PTH and with urinary calcium, with the difference between the means of PTH above and below a 25(OH)D level of 30 ng/mL being significant. At 35 ng/mL, the significance was lost. Using the new cutoff of 30 ng/mL for vitamin D deficiency raised the prevalence among the subjects to 48%, Dr. Sapountzi reported.

A 25(OH)D level of 30 ng/mL also showed significant differences in the urinary calcium levels of patients with 25(OH)D above and below that threshold.

VIENNA — More than half of postmenopausal women being treated for osteoporosis in the United States and the rest of the world have vitamin D levels that are inadequate for skeletal health, according to two recent cross-sectional surveys totalling 2,821 such women in 20 countries.

“Wherever we look in the world, patients are not getting enough vitamin D to maintain calcium homeostasis. … This is a missed opportunity. When we're giving bone-active drugs to patients with osteoporosis, if we don't think about vitamin D inadequacy then we miss the opportunity to ensure that our patients have optimal gains in bone mineral density. And these studies show that the problem is very, very common,” David Hosking, M.D., declared at the annual European congress of rheumatology.

The North American survey involved 1,536 community-dwelling postmenopausal women being treated for osteoporosis. Of these, 52% were found to have a serum 25-hydroxyvitamin D (25[OH]D) level below 30 ng/mL, which most experts define as the cutoff for vitamin D inadequacy from the standpoint of facilitating calcium absorption in the intestine. Both surveys showed the prevalence of secondary hyperparathyroidism began rising as 25(OH)D dropped below 30 ng/mL.

The body senses when intestinal calcium absorption is inadequate. It responds by triggering secondary hyperparathyroidism. The resultant increased parathyroid hormone production leads to greater bone remodeling.

“If you're young, that probably doesn't matter desperately much, but if you're elderly or you're a postmenopausal woman in negative calcium balance, then that amplifies your rate of bone loss,” explained Dr. Hosking of Nottingham (England) City Hospital.

In the international survey, the overall prevalence of vitamin D inadequacy was 59%. (See box.)

“The Middle East was a real surprise. Here, where there's lots of sunshine, we'd imagine that all the patients would be able to make adequate levels of vitamin D. But because it's so searingly hot, hardly anybody goes out in the midday sun and the prevalence of vitamin D deficiency is very high,” he observed at the meeting, which was sponsored by the European League Against Rheumatism.

The prevalence of vitamin D inadequacy in the two surveys was unaffected by latitude. This finding suggests that the casual, “let-the-sun-take-care-of-it” approach to vitamin D that's widespread in more equatorial areas is misplaced, the physician said.

The Institute of Medicine's recommended daily vitamin D intake is 400 IU for individuals aged 51–70 years and 600 IU for those older than 70 years. Yet only 60% of postmenopausal osteoporosis patients in the U.S. survey claimed to be taking at least 400 IU/day. Their rate of vitamin D inadequacy was 45%, as compared with 63% in those not taking a daily supplement of at least 400 IU of vitamin D. But that 45% prevalence is still unacceptably high, Dr. Hosking said, adding that it probably reflects poor compliance with vitamin D therapy.

In the North American survey, multivariate analysis identified eight variables as independent predictors of vitamin D inadequacy: age older than 80 years; obesity; nonwhite race; the use of drugs known to affect vitamin D metabolism; education less than 12th grade; lack of exercise; a daily vitamin D intake lower than 400 IU; and a lack of physician counseling regarding the importance of vitamin D to bone health. Patients with five or more risk factors had a 90% prevalence of inadequate vitamin D.

Two of these risk factors—failure to take an adequate daily vitamin D supplement and lack of physician counseling regarding vitamin D's importance to skeletal health—are readily remediable through patient and physician education. That's the approach Dr. Hosking considers most effective. Some experts advocate modestly increasing sun exposure; however, the skin becomes less efficient at converting sunlight to vitamin D with advancing age, and skin cancer is an issue.

Dr. Hosking was skeptical about taking a public health approach to encourage people to eat more vitamin D-rich foods, as the list of such foods is limited.

“I think for us within osteoporosis, it's much easier to target patients who need vitamin D supplements as part of our treatment because, after all, we're giving them a preparation to control their bone disease, so it's practical to deal with vitamin D at that stage,” he said.

His analysis of the survey data was funded by Merck Sharp & Dohme Ltd. He is a consultant to the company as well as a member of its speakers' bureau.

KEVIN FOLEY, RESEARCH/JULIE KELLER, DESIGN

VIENNA — More than half of postmenopausal women being treated for osteoporosis in the United States and the rest of the world have vitamin D levels that are inadequate for skeletal health, according to two recent cross-sectional surveys totalling 2,821 such women in 20 countries.

“Wherever we look in the world, patients are not getting enough vitamin D to maintain calcium homeostasis. … This is a missed opportunity. When we're giving bone-active drugs to patients with osteoporosis, if we don't think about vitamin D inadequacy then we miss the opportunity to ensure that our patients have optimal gains in bone mineral density. And these studies show that the problem is very, very common,” David Hosking, M.D., declared at the annual European congress of rheumatology.

The North American survey involved 1,536 community-dwelling postmenopausal women being treated for osteoporosis. Of these, 52% were found to have a serum 25-hydroxyvitamin D (25[OH]D) level below 30 ng/mL, which most experts define as the cutoff for vitamin D inadequacy from the standpoint of facilitating calcium absorption in the intestine. Both surveys showed the prevalence of secondary hyperparathyroidism began rising as 25(OH)D dropped below 30 ng/mL.

The body senses when intestinal calcium absorption is inadequate. It responds by triggering secondary hyperparathyroidism. The resultant increased parathyroid hormone production leads to greater bone remodeling.

“If you're young, that probably doesn't matter desperately much, but if you're elderly or you're a postmenopausal woman in negative calcium balance, then that amplifies your rate of bone loss,” explained Dr. Hosking of Nottingham (England) City Hospital.

In the international survey, the overall prevalence of vitamin D inadequacy was 59%. (See box.)

“The Middle East was a real surprise. Here, where there's lots of sunshine, we'd imagine that all the patients would be able to make adequate levels of vitamin D. But because it's so searingly hot, hardly anybody goes out in the midday sun and the prevalence of vitamin D deficiency is very high,” he observed at the meeting, which was sponsored by the European League Against Rheumatism.

The prevalence of vitamin D inadequacy in the two surveys was unaffected by latitude. This finding suggests that the casual, “let-the-sun-take-care-of-it” approach to vitamin D that's widespread in more equatorial areas is misplaced, the physician said.

The Institute of Medicine's recommended daily vitamin D intake is 400 IU for individuals aged 51–70 years and 600 IU for those older than 70 years. Yet only 60% of postmenopausal osteoporosis patients in the U.S. survey claimed to be taking at least 400 IU/day. Their rate of vitamin D inadequacy was 45%, as compared with 63% in those not taking a daily supplement of at least 400 IU of vitamin D. But that 45% prevalence is still unacceptably high, Dr. Hosking said, adding that it probably reflects poor compliance with vitamin D therapy.

In the North American survey, multivariate analysis identified eight variables as independent predictors of vitamin D inadequacy: age older than 80 years; obesity; nonwhite race; the use of drugs known to affect vitamin D metabolism; education less than 12th grade; lack of exercise; a daily vitamin D intake lower than 400 IU; and a lack of physician counseling regarding the importance of vitamin D to bone health. Patients with five or more risk factors had a 90% prevalence of inadequate vitamin D.

Two of these risk factors—failure to take an adequate daily vitamin D supplement and lack of physician counseling regarding vitamin D's importance to skeletal health—are readily remediable through patient and physician education. That's the approach Dr. Hosking considers most effective. Some experts advocate modestly increasing sun exposure; however, the skin becomes less efficient at converting sunlight to vitamin D with advancing age, and skin cancer is an issue.

Dr. Hosking was skeptical about taking a public health approach to encourage people to eat more vitamin D-rich foods, as the list of such foods is limited.

“I think for us within osteoporosis, it's much easier to target patients who need vitamin D supplements as part of our treatment because, after all, we're giving them a preparation to control their bone disease, so it's practical to deal with vitamin D at that stage,” he said.

His analysis of the survey data was funded by Merck Sharp & Dohme Ltd. He is a consultant to the company as well as a member of its speakers' bureau.

KEVIN FOLEY, RESEARCH/JULIE KELLER, DESIGN

VIENNA — More than half of postmenopausal women being treated for osteoporosis in the United States and the rest of the world have vitamin D levels that are inadequate for skeletal health, according to two recent cross-sectional surveys totalling 2,821 such women in 20 countries.

“Wherever we look in the world, patients are not getting enough vitamin D to maintain calcium homeostasis. … This is a missed opportunity. When we're giving bone-active drugs to patients with osteoporosis, if we don't think about vitamin D inadequacy then we miss the opportunity to ensure that our patients have optimal gains in bone mineral density. And these studies show that the problem is very, very common,” David Hosking, M.D., declared at the annual European congress of rheumatology.

The North American survey involved 1,536 community-dwelling postmenopausal women being treated for osteoporosis. Of these, 52% were found to have a serum 25-hydroxyvitamin D (25[OH]D) level below 30 ng/mL, which most experts define as the cutoff for vitamin D inadequacy from the standpoint of facilitating calcium absorption in the intestine. Both surveys showed the prevalence of secondary hyperparathyroidism began rising as 25(OH)D dropped below 30 ng/mL.

The body senses when intestinal calcium absorption is inadequate. It responds by triggering secondary hyperparathyroidism. The resultant increased parathyroid hormone production leads to greater bone remodeling.

“If you're young, that probably doesn't matter desperately much, but if you're elderly or you're a postmenopausal woman in negative calcium balance, then that amplifies your rate of bone loss,” explained Dr. Hosking of Nottingham (England) City Hospital.

In the international survey, the overall prevalence of vitamin D inadequacy was 59%. (See box.)

“The Middle East was a real surprise. Here, where there's lots of sunshine, we'd imagine that all the patients would be able to make adequate levels of vitamin D. But because it's so searingly hot, hardly anybody goes out in the midday sun and the prevalence of vitamin D deficiency is very high,” he observed at the meeting, which was sponsored by the European League Against Rheumatism.

The prevalence of vitamin D inadequacy in the two surveys was unaffected by latitude. This finding suggests that the casual, “let-the-sun-take-care-of-it” approach to vitamin D that's widespread in more equatorial areas is misplaced, the physician said.

The Institute of Medicine's recommended daily vitamin D intake is 400 IU for individuals aged 51–70 years and 600 IU for those older than 70 years. Yet only 60% of postmenopausal osteoporosis patients in the U.S. survey claimed to be taking at least 400 IU/day. Their rate of vitamin D inadequacy was 45%, as compared with 63% in those not taking a daily supplement of at least 400 IU of vitamin D. But that 45% prevalence is still unacceptably high, Dr. Hosking said, adding that it probably reflects poor compliance with vitamin D therapy.

In the North American survey, multivariate analysis identified eight variables as independent predictors of vitamin D inadequacy: age older than 80 years; obesity; nonwhite race; the use of drugs known to affect vitamin D metabolism; education less than 12th grade; lack of exercise; a daily vitamin D intake lower than 400 IU; and a lack of physician counseling regarding the importance of vitamin D to bone health. Patients with five or more risk factors had a 90% prevalence of inadequate vitamin D.

Two of these risk factors—failure to take an adequate daily vitamin D supplement and lack of physician counseling regarding vitamin D's importance to skeletal health—are readily remediable through patient and physician education. That's the approach Dr. Hosking considers most effective. Some experts advocate modestly increasing sun exposure; however, the skin becomes less efficient at converting sunlight to vitamin D with advancing age, and skin cancer is an issue.

Dr. Hosking was skeptical about taking a public health approach to encourage people to eat more vitamin D-rich foods, as the list of such foods is limited.

“I think for us within osteoporosis, it's much easier to target patients who need vitamin D supplements as part of our treatment because, after all, we're giving them a preparation to control their bone disease, so it's practical to deal with vitamin D at that stage,” he said.

His analysis of the survey data was funded by Merck Sharp & Dohme Ltd. He is a consultant to the company as well as a member of its speakers' bureau.

KEVIN FOLEY, RESEARCH/JULIE KELLER, DESIGN