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Studies indicate an effective treatment for steroid-induced osteoporosis
IOWA CITY, Iowa -- University of Iowa researchers, as well as other
researchers, report in the July 30 issue of The New England Journal of
Medicine that the drug alendronate (marketed as Fosamax) may help prevent
and treat steroid-induced osteoporosis.
UI researchers, led by Kenneth Saag, M.D., assistant professor of internal
medicine, and investigators from 14 other U.S. and 22 international sites,
detail the results of two 48-week studies of 477 men and women ages 17
to 83 receiving 7.5 mg or greater of prednisone (or equivalent) daily.
The studies examined the effectiveness of alendronate in preventing and
treating osteoporosis among patients undergoing steroid therapy.
"Steroids such as prednisone are often prescribed by doctors for
a number of medical conditions, including rheumatoid arthritis, asthma
and inflammatory bowel disease," Saag said. "While steroids are
effective in treating these diseases, osteoporosis is often an unavoidable,
yet serious, long-term side effect."
Patients in the studies received either an oral dose of alendronate
(5 mg to 10 mg) or an inactive placebo. All the patients also were given
calcium (800 mg to 1000 mg) and vitamin D supplements (250 to 500 IU),
which are currently recommended for preventing and treating steroid-induced
The researchers found that either dose of alendronate, added to calcium
and vitamin D, significantly increased bone mineral density (BMD) -- the
most important predictor of fracture risk -- at the spine and hip in men
and women taking steroids compared with placebo (calcium and vitamin D).
The results were consistent, regardless of the patient's age, gender, underlying
disease, dosage or length of time on steroid therapy.
Increase in spine BMD was highest in post-menopausal women not taking
estrogen who received 10 mg of alendronate, the researchers noted. Post-menopausal
women taking steroid treatments are among those at the highest risk for
steroid-induced osteoporosis, due to the combined detrimental effects of
estrogen deficiency and steroids on their bones.
The studies also showed fewer patients on alendronate had spine fractures
compared with those patients on placebo.
Researchers already knew that alendronate could prevent and treat postmenopausal
osteoporosis and prevent fractures, Saag noted, but the new study findings
show that the drug can also play a role in preventing and treating osteoporosis
caused by steroids.
Of the 30 million American men and women who have diseases that may
require treatment with glucocorticoid steroids, an estimated one million
people presently use them on a chronic basis.
"Early intervention is critical because steroid users lose large
amounts of bone and lose it rapidly -- as much as 10 to 20 percent in the
first year of steroid treatment," Saag said. "Approximately 50
percent of chronic steroid users develop osteoporosis, increasing their
risk for fractures. Calcium and vitamin D supplements, hormone replacement
therapy and exercise have been the recommended modes of therapy, but our
studies show that alendronate provides additional benefit over and above
calcium plus vitamin D."
In the studies, alendronate at 5 and 10 mg was generally well tolerated.
Esophageal adverse experiences were not increased with alendronate treatment,
nor were peptic ulcers despite concurrent use of steroids in all patients
and extensive use of aspirin, non-steroidal anti-inflammatories and slow-acting
Alendronate, marketed by Merck and Co., Inc., was first approved by
the U.S. Food and Drug Administration in late 1995. It has been prescribed
for approximately 2.4 million people in the United States for the treatment
and prevention of post-menopausal osteoporosis and for the treatment of
Paget's disease of bone.