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Alendronate in Early Postmenopausal Women: Effects on Bone Mass during Long-Term Treatment and after Withdrawal¹

Center for Clinical and Basic Research (P.R.), Ballerup DK-2750, Denmark; San Diego Endocrine and Medical Clinic (S.R.W.), San Diego, California 92108; Catholic University of Chile (J.A.R.-P.), Santiago, Chile; Oregon Osteoporosis Center (M.R.M.), Portland, Oregon 97213; Hawaii Osteoporosis Center (R.D.W.), Honolulu, Hawaii 96814; The Princess Margaret Hospital (N.L.G.), Christchurch 8002, New Zealand; University of Sydney, Royal North Shore Hospital (P.S.), Sydney 2065, Australia; Guy’s Hospital (I.F.), London, United Kingdom SE1 9RT; Merck & Co., Inc. (D.K., A.J.Y., A.D.), Rahway, New Jersey 07065; and American University of Beirut Medical Center (G.E.-H.F.), Beirut, Lebanon

Address all correspondence to: Pernille Ravn, M.D., Center for Clinical and Basic Research, Ballerup Byvej 222, DK-2750 Ballerup, Denmark.

We studied the effect on bone mass of alendronate treatment for 5 yr and its withdrawal. Four hundred and forty-seven postmenopausal women with normal bone mass entered a 3-yr randomized trial followed by a 2-yr open label extension. Three hundred and eleven women completed the first 3 yr, and 263 consented to continue and completed the extension. We are reporting data from groups using the dose of alendronate currently approved for osteoporosis prevention (5 mg) or from the group in which alendronate treatment was withdrawn: 52 women received alendronate (5 mg) for 5 yr (group I), 56 received 3 yr of placebo followed by alendronate (5 mg) for 2 yr (group II), and 52 received alendronate (20 mg) for 2 yr followed by 3 yr off therapy (group III). In group I, alendronate (5 mg) increased bone mineral density (BMD) at the spine and trochanter by 2.5–3.2% (P < 0.001 vs. baseline) and stabilized total body and femoral neck BMD (change vs. baseline, P = NS) over 5 yr. By the end of 5 yr, BMD was comparable at the spine, hip, and total body in groups I and III. The 3-yr decrease in BMD after withdrawal of alendronate (20 mg) in group III was 1.8–5.7% (P < 0.01 vs. baseline) and similar to the 3-yr decrease in BMD in group II during the initial 3 yr. In conclusion, alendronate (5 mg) for 5 yr or alendronate (20 mg) for 2 yr followed by 3 yr off therapy prevented postmenopausal bone loss. After withdrawal of alendronate (20 mg), bone loss resumed at the normal early postmenopausal rate.

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