Background: Observational studies and small trials of short duration suggest that the isoflavone phytoestrogen genistein reduces bone loss, but the evidence is not definitive VSports手机版. .

Objective: To assess the effects of genistein on bone metabolism in osteopenic postmenopausal women. V体育安卓版.

Design: Randomized, double-blind, placebo-controlled trial V体育ios版. .

Setting: 3 university medical centers in Italy VSports最新版本. .

Patients: 389 postmenopausal women with a bone mineral density (BMD) less than 0. 795 g/cm2 at the femoral neck and no significant comorbid conditions V体育平台登录. .

Intervention: After a 4-week stabilization period during which participants received a low-soy, reduced-fat diet, participants were randomly assigned to receive placebo (n = 191) or 54 mg of genistein (n = 198) daily for 24 months VSports注册入口. Both the genistein and placebo tablets contained calcium and vitamin D. .

Measurements: The primary outcome was BMD at the anteroposterior lumbar spine and femoral neck at 24 months. Secondary outcomes were serum levels of bone-specific alkaline phosphatase and insulin-like growth factor I, urinary excretion of pyridinoline and deoxypyridinoline, and endometrial thickness. Data on adverse events were also collected. V体育官网入口.

Results: At 24 months, BMD had increased in genistein recipients and decreased in placebo recipients at the anteroposterior lumbar spine (change, 0. 049 g/cm2 [95% CI, 0. 035 to 0. 059] vs. -0. 053 g/cm2 [CI, -0. 058 to -0. 035]; difference, 0. 10 g/cm2 [CI, 0. 08 to 0. 12]; P < 0. 001) and the femoral neck (change, 0. 035 g/cm2 [CI, 0. 025 to 0. 042] vs. -0 VSports在线直播. 037 g/cm2 [CI, -0. 044 to -0. 027]; difference, 0. 062 g/cm2 [CI, 0. 049 to 0. 073]; P < 0. 001). Genistein statistically significantly decreased urinary excretion of pyridinoline and deoxypyridinoline, increased levels of bone-specific alkaline phosphatase and insulin-like growth factor I, and did not change endometrial thickness compared with placebo. More genistein recipients than placebo recipients experienced gastrointestinal side effects (19% vs. 8%; P = 0. 002) and discontinued the study. .

Limitations: The study did not measure fractures and had limited power to evaluate adverse effects.

Conclusion: Twenty-four months of treatment with genistein has positive effects on BMD in osteopenic postmenopausal women. ClinicalTrials.gov registration number: NCT00355953.