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Alendronate for Postmenopausal Women Without Osteoporosis.

Alendronate can decrease the risk for fractures in postmenopausal women with osteoporosis. Two multisite studies (which were funded and included investigators employed by the drug's manufacturer) tested the efficacy of alendronate in postmenopausal women under age 60 who were not taking hormone replacement.

One randomized study of 1,460 women found that after two years, bone mineral density (BMD) of the lumbar spine decreased 1.8 percent in the placebo group, but increased 2.3 percent and 3.5 percent in alendronate 2.5- and 5-mg groups, respectively; density increased 4 to 5 percent in those assigned to estrogen-progestin therapy. The incidence of fractures (3 to 4 percent) and adverse events was similar in all four groups.

Another study of 447 women found that those randomized to receive at least 5 mg of alendronate daily gained 1 to 4 percent in spine and hip BMD, while the alendronate 1-mg group lost 0 to 2 percent, and the placebo group lost 3 to 4 percent. Immediately after stopping alendronate, the rate of bone loss reverted to that in the placebo group. Although adverse events overall were not different, six cases of odynophagia occurred only in groups assigned to 10 mg or 20 mg of alendronate. A subset of 55 women on the drug had transiliac biopsies that showed no abnormalities of bone.

Comment: Alendronate can prevent bone loss. But an editorialist points out that indefinite therapy is required to maintain its protective effects, and long-term effects in healthy women are unknown. So while alendronate is an option for women at high risk for fracture not taking estrogens, longer-term follow-up is needed to determine if the drug can safely reduce fractures in postmenopausal women without osteoporosis.

— R Saitz

Published in Journal Watch General Medicine February 27, 1998

Citation(s):

Hosking D et al for the Early Postmenopausal Intervention Cohort Study Group. Prevention of bone loss with alendronate in postmenopausal women under 60 years of age. N Engl J Med 1998 Feb 19 338 485-492.

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McClung M et al for the Alendronate Osteoporosis Prevention Study Group. Alendronate prevents postmenopausal bone loss in women without osteoporosis: A double-blind, randomized, controlled trial. Ann Intern Med 1998 Feb 15 128 253-261.

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Heaney RP. Bone mass, bone loss, and osteoporosis prophylaxis. Ann Intern Med 1998 Feb 15 128 313-314.

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