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Effect of hormone therapy on lean body mass, falls, and fractures: 6-year results from the Women's Health Initiative hormone trials

Bea, Jennifer W. PhD1; Zhao, Qiuhong MS2; Cauley, Jane A. DrPH3; LaCroix, Andrea Z. PhD4; Bassford, Tamsen MD5; Lewis, Cora E. MD6; Jackson, Rebecca D. MD7; Tylavsky, Frances A. DPH8; Chen, Zhao PhD1,2

doi: 10.1097/gme.0b013e3181e3aab1

Objective: Loss of lean body mass with aging may contribute to falls and fractures. The objective of this analysis was to determine if taking postmenopausal hormone therapy (or HT: estrogen plus progestogen therapy or estrogen therapy alone) favorably affects age-related changes in lean body mass and if these changes partially account for decreased falls or fractures with HT.

Methods: Participants randomly assigned to either estrogen plus progestogen therapy (n = 543) or control (n = 471) and estrogen therapy alone (n = 453) or control (n = 474) and receiving dual-energy x-ray absorptiometry scans to estimate body composition during the Women's Health Initiative were evaluated. Falls and fracture occurrence were obtained by annual self-report. Fractures were confirmed by a clinical chart review.

Results: At 6 years postrandomization, lean body mass was not different between HT and control groups. Although lean body mass positively influenced bone mineral density, independent of HT status, the preserved lean body mass observed in the HT arms in the first 3 years did not significantly contribute to models evaluating HT influence on falls and fractures between years 3 and 6. Women taking at least 80% of their medication in the HT arms demonstrated fewer falls compared with placebo; this difference was not attributable to change in lean body mass.

Conclusions: Despite early preservation of lean body mass with HT (3 y), HT did not ameliorate long-term (6 y) loss in lean body mass with aging.

An evaluation of 6 years of hormone therapy in postmenopausal women enrolled in the Women's Health Initiative demonstrated that lean body mass preservation up to 3 years does not persist through 6 years of hormone therapy. Falling and fracture rates were not altered by this early lean body mass preservation. Supplemental Digital Content is available in the text.

From the 1Arizona Cancer Center and 2Division of Epidemiology and Biostatistics, Mel and Enid Zuckerman College of Public Health, University of Arizona, Tucson, AZ; 3Department of Epidemiology, University of Pittsburgh, Pittsburgh, PA; 4WHI Clinical Coordinating Center, Fred Hutchinson Cancer Research Center, Seattle, WA; 5Department of Family and Community Medicine, University of Arizona, Tucson AZ; 6Division of Preventive Medicine, University of Alabama, Birmingham, AL; 7Division of Endocrinology, Ohio State University, Columbus, OH; and 8Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis, TN.

Received February 15, 2010; revised and accepted April 12, 2010.

Funding/support: The Women's Health Initiative program is funded by the National Heart, Lung, and Blood Institute, National Institutes of Health, US Department of Health and Human Services through contracts N01WH22110, 24152, 32100-2, 32105-6, 32108-9, 32111-13, 32115, 32118-32119, 32122, 42107-26, 42129-32, and 44221. Dr. Bea was supported by the R25T Cancer Prevention and Control Fellowship (National Institutes of Health/National Cancer Institute CA-78447) during the writing of this manuscript.

Financial disclosure/conflicts of interest: Dr. LaCroix serves on the Scientific Advisory Board for the Postmenopausal Evaluation and Risk-Reduction With Lasofoxifene trial, a multicenter international trial of lasofoxifene sponsored by Pfizer, Inc. Dr. LaCroix also serves as a consultant and site principal investigator to the University of Massachusetts on an unrestricted educational grant funded by the Alliance for Better Bone Health (Proctor and Gamble and Sanofi-Aventis) to design and implement the Global Longitudinal Study of Osteoporosis in Women.

Disclaimer: The authors have no commercial, proprietary, or financial interest in the products or instruments described in this article.

Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal's Web site (

Address correspondence to: Jennifer W. Bea, PhD, Arizona Cancer Center, 1515 N. Campbell Ave., P.O. Box 245024, Tucson, AZ 85724-5024. E-mail:

©2011The North American Menopause Society