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Significant Differential Effects of Alendronate, Estrogen, or Combination Therapy on the Rate of Bone Loss after Discontinuation of Treatment of Postmenopausal Osteoporosis: A Randomized, Double-Blind, Placebo-Controlled Trial

Susan L. Greenspan, MD; Ronald D. Emkey, MD; Henry G. Bone III, MD; Stuart R. Weiss, MD; Norman H. Bell, MD; Robert W. Downs Jr., MD; Clark McKeever, MD; Sam S. Miller, MD; Michael Davidson, MD; Michael A. Bolognese, MD, PC; Anthony L. Mulloy, PhD, DO; Norman Heyden, RPh, MS; Mei Wu, MS; Amarjot Kaur, PhD; and Antonio Lombardi, MD
[+] Article and Author Information

From University of Pittsburgh, Pittsburgh, and Radiant Research Reading, Wyomissing, Pennsylvania; Beth Israel Deaconess Medical Center, Boston, Massachusetts; Michigan Bone and Mineral Clinic, Detroit, Michigan; San Diego Endocrinology and Medical Clinic, San Diego, California; Medical University of South Carolina, Charleston, South Carolina; Virginia Commonwealth University, Richmond, Virginia; Research for Health, Houston, and SAM Clinical Research Center, San Antonio, Texas; Chicago Center for Clinical Research, Chicago, Illinois; Bethesda Health Research, Bethesda, Maryland; Medical College of Georgia, Augusta, Georgia; and Merck and Co., Inc., Rahway, New Jersey.


Grant Support: By a grant from Merck Research Laboratories, Rahway, New Jersey, to the individual study sites.

Requests for Single Reprints: Susan L. Greenspan, MD, University of Pittsburgh, Osteoporosis Prevention and Treatment Center, Kaufmann Medical Building, Suite 1110, 3471 Fifth Avenue, Pittsburgh, PA 15213; e-mail, GriffithsD@msx.dept-med.pitt.edu.

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

Dr. McKeever: Touch Research Inc., 800 Gessner, Suite 200, Houston, TX 77024.

Dr. Miller: SAM Clinical Research Center, 7711 Louis Pasteur, Suite 300, San Antonio, TX 78229.

Dr. Weiss: San Diego Endocrine and Medical Clinic, 5920 Friars Road, Suite 208, San Diego, CA 92108.

Dr. Emkey: Radiant Research Reading, 1235 Penn Avenue, Suite 200, Wyomissing, PA 19610.

Dr. Downs: Virginia Commonwealth University, 1101 E. Marshall Street, 7-015, Richmond, VA 23298-0111.

Dr. Bell: Medical University of South Carolina, Strom Thurmond Building, Room 548, 114 Doughty Street, Charleston, SC 29425.

Dr. Bone: Michigan Bone and Mineral Clinic, 22201 Moross Road, Suite 260, Detroit, MI 48236.

Dr. Davidson: Chicago Center for Clinical Research, 515 North State Street, Suite 2700, Chicago, IL 60610-4324.

Dr. Bolognese: Bethesda Health Research, 10215 Fernwood Road, Suite 40, Bethesda, MD 20817.

Dr. Mulloy: Medical College of Georgia, Section of Endocrinology and Nutrition, 1467 Harper Street, HB-5025, Augusta, GA 30912-3115.

Mr. Heyden and Ms. Wu: Merck Research Laboratories, PO Box 2000, Rahway, NJ 07065.

Dr. Kaur: Merck Research Laboratories, 126 East Lincoln Avenue, RY33-404, Rahway, NJ 07065.

Dr. Lombardi: Merck & Co., Inc., 126 East Lincoln Avenue, RY32-545, Rahway, NJ 07065.

Author Contributions: Conception and design: H.G. Bone, R.W. Downs, S.S. Miller.

Analysis and interpretation of the data: S.L. Greenspan, S.S. Miller, M. Wu.

Drafting of the article: S.L. Greenspan, S.S. Miller.

Critical revision of the article for important intellectual content: S.L. Greenspan.

Final approval of the article: S.L. Greenspan, H.G. Bone, N.H. Bell, R.W. Downs, S.S. Miller, M. Wu.

Provision of study materials or patients: S.L. Greenspan, R.D. Emkey, H.G. Bone, S.R. Weiss, N.H. Bell, R.W. Downs, C. McKeever, S.S. Miller, M. Davidson, M.A. Bolognese, A.L. Mulloy.

Statistical expertise: M. Wu.

Obtaining of funding: S.L. Greenspan.

Administrative, technical, or logistic support: N.H. Bell, N. Heyden.

Collection and assembly of data: S.L. Greenspan, R.D. Emkey, H.G. Bone, S.R. Weiss, N.H. Bell, C. McKeever, S.S. Miller, M. Davidson, M.A. Bolognese, N. Heyden.


Ann Intern Med. 2002;137(11):875-883. doi:10.7326/0003-4819-137-11-200212030-00008
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Postmenopausal women with hysterectomy who received estrogen for 2 years and were then switched to placebo for year 3 had a statistically significant loss of bone mineral density at the spine (4.5%), total hip (1.8%), femoral neck (2.4%), and trochanter (2.4%) during the third year. In contrast, women who received alendronate alone or in combination with conjugated estrogens for 2 years and were then switched to placebo for year 3 maintained gains in spine and hip bone mineral density that were attained during the preceding 2 years. At 3 years, bone mineral density at the spine, femoral neck, and trochanter was significantly higher in the group taking alendronate or combination therapy and switched to placebo than in the group previously taking estrogen. Women who continued taking combination therapy with alendronate and conjugated estrogen for a third year had a spine bone mineral density that was 11.3% higher and a hip bone mineral density that was 6.6% higher than those in the placebo group.

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Figures

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Figure 1.
Design of original 2-year study and reallocation to extension phase for year 3.

CE = conjugated estrogen.

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Figure 2.
Mean (±SE) percentage change from year 2 to year 3 in bone mineral density (BMD) at the lumbar spine, total hip, and total body.PP

Vertical lines represent SEs. * ≤ 0.001; † ≤ 0.01. CE = conjugated estrogen.

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Figure 3.
Mean percentage change from baseline to year 3 in bone mineral density (BMD).

Vertical lines represent SEs. Dotted lines represent placebo period. CE = conjugated estrogen.

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Figure 4.
Mean percentage change from baseline to year 3 in biochemical markers of bone turnover.NCE

Data were obtained from per-protocol analyses. Data on urinary -telopeptide cross-links of collagen type I and serum bone-specific alkaline phosphatase, respectively, were available in the following numbers of patients: 26 and 27 in the placebo/placebo group, 38 and 39 in the alendronate/placebo group, 72 and 74 in the conjugated estrogen ( )/placebo group, 35 and 36 in the combination therapy/combination therapy group, and 32 and 33 in the combination therapy/placebo group. Dotted lines represent placebo period.

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Summary for Patients

Bone Loss after Stopping Estrogen or Alendronate Therapy

The summary below is from the full report titled “Significant Differential Effects of Alendronate, Estrogen, or Combination Therapy on the Rate of Bone Loss after Discontinuation of Treatment of Postmenopausal Osteoporosis. A Randomized, Double-Blind, Placebo-Controlled Trial.” It is in the 3 December 2002 issue of Annals of Internal Medicine (volume 137, pages 875-883). The authors are SL Greenspan, RD Emkey, HG Bone III, SR Weiss, NH Bell, RW Downs Jr., C McKeever, SS Miller, M Davidson, MA Bolognese, AL Mulloy, N Heyden, M Wu, A Kaur, and A Lombardi.

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