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Low-fat, increased fruit, vegetable, and grain dietary pattern, fractures, and bone mineral density: the Women's Health Initiative Dietary Modification Trial^1,2,3

¹ From the Fred Hutchinson Cancer Research Center, Division of Public Health Sciences, Seattle, WA (AM, LW, and RJR); the University of Washington, Department of Epidemiology, School of Public Health and Community Medicine, and Department of Medicine, School of Medicine, Seattle, WA (AM); the Department of Social and Preventive Medicine, University at Buffalo, State University of New York, Buffalo, NY (JW-W); the University of Cincinnati College of Medicine, Department of Internal Medicine, Cincinnati, OH (NBW); the Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis, TN (FT); the Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, NY (RF); the Hutzel Women's Health Specialists, Detroit, MI (SH); and the Ohio State University, Columbus, OH (RJ).

² The Women's Health Initiative is funded by the National Heart, Lung, and Blood Institute, US Department of Health and Human Services.

³ Address correspondence to A McTiernan, Fred Hutchinson Cancer Research Center, Division of Public Health Sciences, M4-B402, PO Box 19024, Seattle, WA 98019. E-mail: amctiern{at}fhcrc.org.

for the Women's Health Initiative Investigators

Background: The effects of dietary changes on osteoporosis, low bone density, and frequent falls are unestablished.

Objective: We assessed the effect of the Women's Health Initiative Dietary Modification low-fat and increased fruit, vegetable, and grain intervention on incident hip, total, and site-specific fractures and self-reported falls, and, in a subset, on bone mineral density (BMD).

Design: Postmenopausal women (n = 48,835) aged 50–79 y (18.6% of minority race-ethnicity) were randomly assigned to receive the Dietary Modification intervention (40%, n = 19,541) (daily goal: 20% of energy as fat, 5 servings of vegetables and fruit, and 6 servings of grains) or to a comparison group that received no dietary changes (60%; n = 29,294).

Results: After a mean 8.1 y of follow-up, 215 women in the intervention group and 285 women in the comparison group (annualized rate: 0.14% and 0.12%, respectively) experienced a hip fracture (hazard ratio: 1.12; 95% CI: 0.94, 1.34; P = 0.21). The intervention group (n = 5423; annualized rate: 3.44%) had a lower rate of reporting 2 falls than did the comparison group (n = 8695; annualized rate: 3.67%) (HR: 0.92; 95% CI: 0.89, 0.96; P < 0.01). There was a significant interaction according to hormone therapy use; those in the comparison group receiving hormone therapy had the lowest incidence of hip fracture. In a subset of 3951 women, hip BMD at years 3, 6, and 9 was 0.4–0.5% lower in the intervention group than in the comparison group (P = 0.003).

Conclusions: A low-fat and increased fruit, vegetable, and grain diet intervention modestly reduced the risk of multiple falls and slightly lowered hip BMD but did not change the risk of osteoporotic fractures. This trial was registered at clinicaltrials.gov as NCT00000611.