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Efficacy of ipriflavone in established osteoporosis and long-term safety

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Abstract

Ipriflavone (IP), 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 IP (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 fore-arm bone mineral density (BMD), measured by dual photon absorptiometry (DPA), was obtained after IP 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 IP-treated patients, suggesting a reduction in bone turnover rate. A reduction of incident vertebral fractures was observed in IP-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 IP, 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 IP may be considered safe, and may increase bone density and possibly prevent fractures in elderly patients with established osteoporosis.

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Authors and Affiliations

  1. Institute of Internal Medicine and Medical Pathology, University of Siena, Italy

    D. Agnusdei

  2. Medical Department, Chiesi Farmaceutici, SpA, via Palermo 26/a, 43100, Parma, Italy

    L. Bufalino

Authors
  1. D. Agnusdei
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  2. L. Bufalino
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Agnusdei, D., Bufalino, L. Efficacy of ipriflavone in established osteoporosis and long-term safety. Calcif Tissue Int 61 (Suppl 1), S23–S27 (1997). https://doi.org/10.1007/s002239900381

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  • DOI: https://doi.org/10.1007/s002239900381

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