Efficacy of ipriflavone in established osteoporosis and long-term safety.

Abstract

Ipriflavone (i.p.), an isoflavone derivative, is currently used in several countries for prevention and treatment of osteoporosis. Recently, 149 elderly, osteoporotic women (65-79 years) with prevalent vertebral fractures were enrolled in two Italian, multicenter, double-blind, 2-year studies. Women were randomly allocated to receive either oral i.p. (200 mg T.I.D. at meals) or matching placebo, plus 1 g oral calcium daily. One hundred eleven subjects completed the 2-year treatment period. A significant increase in forearm bone mineral density (BMD), measured by dual photon absorptiometry (DPA), was obtained after i.p. treatment. Women receiving the placebo showed only a limited bone loss during the treatment period, probably due to calcium supplement; however, a significant between-treatment difference was obtained in both studies. Urinary hydroxyproline was significantly decreased in i.p.-treated patients, suggesting a reduction in bone turnover rate. A reduction of incident vertebral fractures was observed in i.p.-treated women compared with control subjects. A significant improvement of bone pain and mobility has also been pointed out in one of the studies. To date, 2769 patients have been treated with i.p., for a total of 3132 patient/years, in 60 clinical studies performed in Italy, Japan, and Hungary and reviewed for long-term safety assessment. The incidence of adverse reactions in ipriflavone-treated patients (14.5%) was similar to that observed in subjects receiving the placebo (16.1%). Side effects were mainly gastrointestinal. Few patients presented reversible modifications of laboratory parameters. The data from the above studies show that long-term treatment with i.p. may be considered safe, and may increase bone density and possibly prevent fractures in elderly patients with established osteoporosis.