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Alendronate Improves Bone Mineral Density in Elderly Women with Osteoporosis Residing in Long-Term Care Facilities: A Randomized, Double-Blind, Placebo-Controlled Trial

Susan L. Greenspan, MD; Diane L. Schneider, MD; Michael R. McClung, MD; Paul D. Miller, MD; Thomas J. Schnitzer, MD, PhD; Randi Bonin, BS; Mary Elizabeth Smith, BS; Paul DeLucca, PhD; Glenn J. Gormley, MD, PhD; and Mary E. Melton, MD
[+] Article and Author 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@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.


Ann Intern Med. 2002;136(10):742-746. doi:10.7326/0003-4819-136-10-200205210-00009
Text Size: A A A

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.

Figures

Grahic Jump Location
Figure 1.
Changes in bone mineral density (BMD).circlessquaresPPPPP

Values are mean percentage changes in BMD of the posterior–anterior lumbar spine, lateral lumbar spine, hip trochanter, and femoral neck with 10 mg of alendronate per day ( ) or placebo ( ) over 24 months. values refer to between-group comparisons. For alendronate, within-group changes from baseline are significant at each time point and at each site ( < 0.001). In the placebo group, increases in BMD over baseline values were significant only at the lumbar spine (posterior–anterior lumbar spine, < 0.001 at 6, 12, and 24 months; lateral lumbar spine, = 0.031 at 6 months and = 0.008 at 24 months). Bars represent 95% CIs.

Grahic Jump Location
Grahic Jump Location
Figure 2.
Changes in biochemical markers of bone turnover.NcirclessquaresPPPPPN

Values are back-transformed mean log percentage changes from baseline in levels of serum bone-specific alkaline phosphatase and urinary -telopeptide adjusted for urinary creatinine with 10 mg of alendronate per day ( ) or placebo ( ) over 24 months. values refer to between-group comparisons. In the alendronate group, changes from baseline for both measures were significant ( < 0.001) at each time point. In the placebo group, within-group changes in bone-specific alkaline phosphatase level were significant at months 3 and 6, 12, and 24 ( < 0.001, = 0.003, and = 0.014, respectively); levels of urinary -telopeptide adjusted for urinary creatinine did not differ from baseline at any time point. Bars represent 95% CIs.

Grahic Jump Location

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Summary for Patients

Alendronate Improves Osteoporosis in Elderly Women Living in Long-Term Care Facilities

The summary below is from the full report titled “Alendronate Improves Bone Mineral Density in Elderly Women with Osteoporosis Residing in Long-Term Care Facilities. A Randomized, Double-Blind, Placebo- Controlled Trial.” It is in the 21 May 2002 issue of Annals of Internal Medicine (volume 136, pages 742-746). The authors are SL Greenspan, DL Schneider, MR McClung, PD Miller, TJ Schnitzer, R Bonin, ME Smith, P DeLucca, GJ Gormley, and ME Melton.

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