Research paper
Soy isoflavone supplementation and bone mineral density in menopausal women: a 2-y multicenter clinical trial.
Study answer
What this study found
The 120 mg/day regimen produced a modest whole-body bone benefit, but the clinical impact was limited. Adjusted whole-body BMD was significantly higher for 120 mg/day vs placebo after 1 and 2 years (sequential Sidak-adjusted P = 0.04), whereas 80 mg/day was not significant (P = 0.13). Neither dose slowed bone loss at the lumbar spine or total hip, and bone turnover markers (osteocalcin, BAP, NTx) were not favorably altered. Serious adverse events were reported in both active arms, including one breast cancer in the 120 mg/day group and one stage 1B, grade III squamous carcinoma of the…
- Study & population
- Multicenter, placebo-controlled 2-year clinical trial in healthy postmenopausal women in the United States.
- Intervention
- Healthy postmenopausal women were randomized in a 3-arm multicenter trial to oral soy hypocotyl aglycone isoflavone tablets at 80 mg/day or 120 mg/day, taken as 3 tablets daily for 24 months, versus placebo.
- Key limitation
- The benefit was small and confined to whole-body BMD, not the common fracture sites most relevant to clinical decision-making.
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Open PDFOriginal abstract
BACKGROUND Isoflavones are naturally occurring plant estrogens that are abundant in soy. Although purported to protect against bone loss, the efficacy of soy isoflavone supplementation in the prevention of osteoporosis in postmenopausal women remains…