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Volume 333:1437-1444 November 30, 1995 Number 22 Next

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ABSTRACT

Background Postmenopausal osteoporosis is a serious health problem, and additional treatments are needed.

Methods We studied the effects of oral alendronate, an aminobisphosphonate, on bone mineral density and the incidence of fractures and height loss in 994 women with postmenopausal osteoporosis. The women were treated with placebo or alendronate (5 or 10 mg daily for three years, or 20 mg for two years followed by 5 mg for one year); all the women received 500 mg of calcium daily. Bone mineral density was measured by dual-energy x-ray absorptiometry. The occurrence of new vertebral fractures and the progression of vertebral deformities were determined by an analysis of digitized radiographs, and loss of height was determined by sequential height measurements.

Results The women receiving alendronate had significant, progressive increases in bone mineral density at all skeletal sites, whereas those receiving placebo had decreases in bone mineral density. At three years, the mean (±SE) differences in bone mineral density between the women receiving 10 mg of alendronate daily and those receiving placebo were 8.8±0.4 percent in the spine, 5.9±0.5 percent in the femoral neck, 7.8±0.6 percent in the trochanter, and 2.5±0.3 percent in the total body (P<0.001 for all comparisons). The 5-mg dose was less effective than the 10-mg dose, and the regimen of 20 mg followed by 5 mg was similar in efficacy to the 10-mg dose. Overall, treatment with alendronate was associated with a 48 percent reduction in the proportion of women with new vertebral fractures (3.2 percent, vs. 6.2 percent in the placebo group; P = 0.03), a decreased progression of vertebral deformities (33 percent, vs. 41 percent in the placebo group; P = 0.028), and a reduced loss of height (P = 0.005) and was well tolerated.

Conclusions Daily treatment with alendronate progressively increases the bone mass in the spine, hip, and total body and reduces the incidence of vertebral fractures, the progression of vertebral deformities, and height loss in postmenopausal women with osteoporosis.

Source Information

From the Department of Metabolic Disease, Beilinson Medical Center, Tel Aviv University, Petah-Tikva, Israel (U.A.L.); the San Diego Endocrine and Medical Clinic, San Diego, Calif. (S.R.W.); the Department of Medicine, Kaiser Franz Josef Hospital, Vienna, Austria (J.B.); Klinik der Fürstenhof, Bad Pyrmont, Germany (H.W.M.); Merck Research Laboratories, Rahway, N.J. (H.Q., T.C., A.C.S., A.L., R.V.S., L.J.H., D.B.K.); the Department of Research Services, Veterans Affairs Medical Center, Charleston, S.C. (N.H.B.); the Department of Endocrinology, School of Medicine, Catholic University of Chile, Santiago (J.R.-P.); the Department of Medicine, Medical College of Virginia, Richmond (R.W.D.); the Department of Rheumatology, Catholic University Leuven, Leuven, Belgium (J.D.); the Department of Medicine, University of Chicago, Chicago (M.F.); the Department of Endocrinology, Austin Hospital, Heidelberg, Australia (E.S.); and the Center for Osteoporosis Research, Creighton University, Omaha, Nebr. (R.R.R.). Presented in part at the 77th Annual Meeting of the Endocrine Society, Washington, D.C., June 14–17, 1995.

Address reprint requests to Dr. Liberman at Metabolic Diseases, Beilinson Medical Center, 49100, Petah-Tikva, Israel.

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