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Volume 338:485-492 February 19, 1998 Number 8 Next

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ABSTRACT

Background Estrogen-replacement therapy prevents osteoporosis in postmenopausal women by inhibiting bone resorption, but the balance between its long-term risks and benefits remains unclear. Whether other antiresorptive therapies can prevent osteoporosis in these women is also not clear.

Methods We studied the effect of 2.5 mg or 5 mg of alendronate per day or placebo on bone mineral density in 1174 postmenopausal women under 60 years of age. An additional 435 women who were prepared to receive a combination of estrogen and progestin were randomly assigned to one of the above treatments or open-label estrogen–progestin. The main outcome measure was the change in bone mineral density of the lumbar spine, hip, distal forearm, and total body measured annually for two years by dual-energy x-ray absorptiometry.

Results The women who received placebo lost bone mineral density at all measured sites, whereas the women treated with 5 mg of alendronate daily had a mean (±SE) increase in bone mineral density of 3.5±0.2 percent at the lumbar spine, 1.9±0.1 percent at the hip, and 0.7±0.1 percent for the total body (all P<0.001). Women treated with 2.5 mg of alendronate daily had smaller increases in bone mineral density. Alendronate did not increase bone mineral density of the forearm, but it slowed the loss. The responses to estrogen–progestin were 1 to 2 percentage points greater than those to the 5-mg dose of alendronate. Alendronate was well tolerated, with a safety profile similar to that of placebo or estrogen–progestin.

Conclusions Alendronate prevents bone loss in postmenopausal women under 60 years of age to nearly the same extent as estrogen–progestin.

Source Information

From the Division of Mineral Metabolism, City Hospital (D.H.), and the School of Community Health Sciences, University of Nottingham Medical School (C.E.D.C.), Nottingham, United Kingdom; the Center for Clinical and Basic Research, Ballerup, Denmark (C.C., P. Ravn); the Hawaii Osteoporosis Center, Honolulu (R.W., P. Ross); Oregon Osteoporosis Center, Providence Health System, Portland (M.M., A.B.); and Merck Research Laboratories, Rahway, N.J. (D.T., M.D., A.J.Y.).

Address reprint requests to Dr. Hosking at the Division of Mineral Metabolism, City Hospital, Hucknall Rd., Nottingham NG5 1PB, United Kingdom.

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