Abstract
The capability of ipriflavone to prevent the postmenopausal decline of bone mineral density (BMD) was evaluated in healthy postmenopausal women (ages 50-60 years) 1-5 years after menopause. In this randomized study, subjects received I g/day of calcium plus either a placebo or ipriflavone (200 mg × 3/day; n = 62). for 24 months. At baseline and after 6. 12. 18. and 24 months, BMD was evaluated, along with the biochemical parameters of bone metabolism, patient compliance, ability to tolerate treatment and safety. In group 1 (70 women), BMD was evaluated at the distal one-tenth of the nondominant radius by dual photon absorptiometry, and in group 2 (40 women) at the lumbar spine (L2-L4) by DEXA. Drop-outs were three in group I and five in group 2. At the distal radius. BMD decreased significantly (p < 0.0001) during placebo and increased during ipriflavone administration. At the lumbar spine, ipriflavone prevented the decrease of BMD observed during placebo (p < 0.025). Biochemical and endocrine parameters of bone metabolism were not modified by ipriflavone. except for an increase in circulating calcitonin (p < 0.01) and a reduction in the urinary excretion of hydroxyproline (p < 0.02). Patient compliance was good, and ipriflavone was safe and well tolerated. Ipriflavone may represent a useful aid for the prevention of BMD decline in postmenopausal women.
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