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

A Randomized, Double-Blind, Placebo-Controlled Trial

  1. Susan L. Greenspan, MD;
  2. Diane L. Schneider, MD;
  3. Michael R. McClung, MD;
  4. Paul D. Miller, MD;
  5. Thomas J. Schnitzer, MD, PhD;
  6. Randi Bonin, BS;
  7. Mary Elizabeth Smith, BS;
  8. Paul DeLucca, PhD;
  9. Glenn J. Gormley, MD, PhD; and
  10. Mary E. Melton, MD
  1. 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.

    Abstract

    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.

    Article and Author Information

    • 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.

    « Previous | Next Article »Table of Contents

    This Article

    1. Ann Intern Med May 21, 2002 vol. 136 no. 10 742-746
    1. » Abstract
    2. Figures
    3. Full Text
    4. Full Text (PDF)

    Rapid Responses

    1. Submit a response
    2. No responses published

    Current Issue

    1. November 17, 2009, 151 (10)
    1. Alert me to current issues