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21 December 1999 | Volume 131 Issue 12 | Pages 935-942
Background: Up to 3 years of treatment with alendronate, 5 mg/d, prevents postmenopausal bone loss.
Objective: To determine whether the effect of alendronate is sustained at 4 years of treatment and persists after treatment is discontinued.
Design: Randomized, controlled trial.
Setting: United States and Europe.
Participants: 1609 postmenopausal women 45 to 59 years of age.
Intervention: Participants were randomly assigned to receive oral alendronate, 5 mg/d or 2.5 mg/d; placebo; or open-label estrogen–progestin. Women in the alendronate groups received alendronate for the first 2 years of the study. Treatment was then continued without change or replaced with placebo for the last 2 years of the study.
Measurements: Annual measurement of bone mineral density.
Results: By year 4, the bone mineral density of participants in the placebo group had decreased by 1% to 6% (P < 0.001). Four years of treatment with 5 mg of alendronate per day increased bone mineral density at the spine (mean change [±SE], 3.8% ± 0.3%), hip (mean, 2.9% ± 0.2%), and total body (mean, 0.9% ± 0.2%) (P < 0.001 overall). By year 4, bone mineral density at most skeletal sites was greater in participants who switched from alendronate to placebo than in those who continuously received placebo. In years 3 and 4, bone loss in participants who switched from alendronate to placebo was similar to that seen during years 1 and 2 in those who continuously received placebo. Compared with 5 mg of alendronate per day, estrogen-medroxyprogesterone acetate produced similar increases in bone mineral density and estradiol-norethisterone acetate produced increases that were substantially greater.
Conclusions: Four years of treatment with alendronate or estrogen–progestin prevented postmenopausal bone loss. A residual effect was seen 2 years after alendronate therapy was stopped; however, continuous alendronate treatment was more effective in preventing postmenopausal bone loss than 2 years of alendronate followed by 2 years of placebo.
*For members of the Early Postmenopausal Intervention Cohort Study Group, see Appendix.
Author and Article Information
From Center for Clinical and Basic Research, Ballerup, Denmark; Hawaii Osteoporosis Center, Honolulu, Hawaii; Oregon Osteoporosis Center, Portland, Oregon; City Hospital, Nottingham, United Kingdom; and Merck & Co., Inc., Rahway, New Jersey.
Acknowledgment: This paper is dedicated to the memory of Dr. Anthony Lyons, who was a major contributor to the Early Postmenopausal Intervention Cohort Study.
Grant Support: In part by Merck Research Laboratories, in the form of research grants to the individual study sites.
Requests for Reprints: Pernille Ravn, MD, Center for Clinical and Basic Research, Ballerup Byvej 22, DK-2750 Ballerup, Denmark. For reprint orders in quantities exceeding 100, please contact the Reprints Coordinator; phone, 215-351-2657; e-mail, reprints{at}mail.acponline.org.
Current Author Addresses: Drs. Ravn and Bidstrup: Center for Clinical and Basic Research, Ballerup Byvej 222, DK-2750 Ballerup, Denmark.
Drs. Wasnich and Davis: Hawaii Osteoporosis Center, 401 Kamakee Street, Second Floor, Honolulu, HI 96814-4224.
Drs. McClung and Balske: Oregon Osteoporosis Center, 5050 NE Hoyt Street, Suite 651, Portland, OR 97213.
Dr. Coupland and Dr. Sahota: Bone and Mineral Unit, City Hospital, Hucknall Road, Nottingham NG5 1PB, United Kingdom.
Dr. Kaur, Ms. Daley, and Dr. Cizza: Merck & Co., Inc., 126 East Lincoln Avenue, P.O. Box 2000, RY32-549, Rahway NJ 07065-0914. ARTICLE
Alendronate and Estrogen–Progestin in the Long-Term Prevention of Bone Loss: Four-Year Results from the Early Postmenopausal Intervention Cohort Study: A Randomized, Controlled Trial
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