Alendronate Improves Bone Mineral Density in Elderly Women with Osteoporosis Residing in Long-Term Care Facilities

A Randomized, Double-Blind, Placebo-Controlled Trial

21 May 2002 | Volume 136 Issue 10 | Pages 742-746

Background: Many elderly female residents of long-term care facilities have osteoporosis and could benefit from intervention to increase bone density.

Objective: To examine the efficacy and safety of alendronate for treatment of osteoporosis in elderly female residents of long-term care facilities.

Design: Multicenter, randomized, double-blind, placebo-controlled 2-year study.

Setting: 25 long-term care facilities.

Patients: 327 elderly women with osteoporosis.

Intervention: Patients were randomly assigned to receive alendronate, 10 mg/d, or placebo. All patients also received vitamin D, 400 IU/d, and some patients received supplemental calcium (total intake, approximately 1500 mg/d).

Measurements: Bone mineral density (BMD) of the spine and hip and biochemical markers of bone turnover.

Results: Alendronate produced significantly greater increases in BMD than did placebo (24-month differences: spine, 4.4% [95% CI, 3.3% to 5.5%]; femoral neck, 3.4% [CI, 2.3% to 4.4%]). Alendronate produced greater decreases from baseline in biochemical markers of bone turnover than did placebo (P < 0.001).

Conclusion: Alendronate increased BMD at both the spine and hip in elderly female residents of long-term care facilities.

For a list of investigators and investigative sites, see the Appendix.

Editors' Notes Context Although the prevalence of osteoporosis increases with advancing age, most therapeutic studies have focused on younger postmenopausal women. It is not known whether treatment is effective in elderly women. Contribution The efficacy and tolerability of alendronate in elderly female residents of long-term care facilities were tested in a 2-year randomized, double-blind, placebo-controlled study. Alendronate significantly increased bone mineral density and decreased bone turnover when compared with placebo in this elderly population. Side effects did not differ between treatment groups. Implications Elderly women with osteoporosis may benefit from alendronate therapy. The effect of this therapy on incidence of fractures or the optimum length of therapy cannot be determined from this study. –The Editors

 

Author and Article Information

From Beth Israel Deaconess Medical Center, Boston, Massachusetts; University of California, San Diego, La Jolla, California; Oregon Osteoporosis Center, Portland, Oregon; Colorado Center for Bone Research, Lakewood, Colorado; Rush-Presbyterian-St. Luke's Medical Center, Chicago, Illinois; and Merck & Co., Inc., West Point, Pennsylvania.

Acknowledgments: The authors thank Mary Weeks and Kim Hoffman for coordinating the early phases of the study and Christine Byrnes, MD, for providing expertise in study conduct.

Grant Support: By Merck & Co., Inc.

Requests for Single Reprints: Mary E. Melton, MD, Merck & Co., Inc., One Merck Drive, WS 3CD-45, Whitehouse Station, NJ 08889; e-mail, mary_melton{at}merck.com.

Current Author Addresses: Dr. Greenspan: University of Pittsburgh Osteoporosis Prevention & Treatment Center, 1110 Kaufmann Building, 3471 Fifth Avenue, Pittsburgh, PA, 15213.

Dr. Schneider: University of California, San Diego, 9500 Gilman Drive, La Jolla, CA 92093.

Dr. McClung: Oregon Osteoporosis Center, 5050 NE Hoyt, Suite 651, Portland, OR 97213.

Dr. Schnitzer: Office of Clinical Research and Training, Northwestern University, 710 N. Lake Shore Drive, Room 501, Chicago, IL 60611.

Dr. Miller: Colorado Center for Bone Research, 3190 S. Wadsworth Boulevard, Suite 250, Lakewood, CO 80227.

Ms. Bonin, Ms. Smith, and Dr. DeLucca: Merck & Co., Inc., PO Box 4, West Point, PA 19486.

Dr. Gormley: AstraZeneca Pharmaceuticals LP, 1800 Concord Pike, Wilmington, DE 19850.

Dr. Melton: Merck & Co., Inc., One Merck Drive, WS 3CD-45, Whitehouse Station, NJ 08889.

Author Contributions: Conception and design: S. Greenspan, P.D. Miller, G.J. Gormley, M.E. Melton.

Analysis and interpretation of the data: S. Greenspan, D.L. Schneider, P.D. Miller, T.J. Schnitzer, P.T. DeLucca, G.J. Gormley, M.E. Melton.

Drafting of the article: S. Greenspan, D.L. Schneider, T.J. Schnitzer, R. Bonin, P.T. DeLucca, M.E. Melton.

Critical revision of the article for important intellectual content: S. Greenspan, D.L. Schneider, M.R. McClung, P.D. Miller, T.J. Schnitzer, P.T. DeLucca, G.J. Gormley, M.E. Melton.

Final approval of the article: S. Greenspan, D.L. Schneider, M.R. McClung, P.D. Miller, T.J. Schnitzer, R. Bonin, M.E. Smith, P.T. DeLucca, G.J. Gormley, M.E. Melton.

Provision of study materials or patients: S. Greenspan, D.L. Schneider, M.R. McClung, P.D. Miller, T.J. Schnitzer, R. Bonin, M.E. Melton.

Statistical expertise: P.T. DeLucca.

Obtaining of funding: S. Greenspan, G.J. Gormley.

Administrative, technical, or logistic support: R. Bonin, M.E. Smith, M.E. Melton.

Collection and assembly of data: R. Bonin, M.E. Smith, M.E. Melton.