Effect of chronic treatment with ipriflavone in postmenopausal women with low bone mass

C. Gennari, S. Adami, D. Agnusdei, L. Bufalino, R. Cervetti, G. Crepaldi, C. Di Marco, O. Di Munno, L. Fantasia, G. C. Isaia, G. F. Mazzuoli, S. Ortolani, M. Passeri, U. Serni, L. Vecchiet

Research output: Contribution to journalArticle

Abstract

We present the results of two multicenter, double-blind, placebo- controlled, 2-year studies to evaluate the efficacy and tolerability of ipriflavone in postmenopausal women (PMW) with low bone mass. 453 PMW (aged 50-65 years) with a vertebral (VMD) or radial (RMD) mineral density value 1 SD lower compared with agematched controls, were randomly selected to receive oral ipriflavone (200 mg T.I.D. at meals) or matching placebo, plus 1 g oral calcium daily. Vertebral (study A, by dual X-ray absorptiometry-DXA) and radial (study B, by dual photon absorptiometry-DPA) bone density, serum bone Gla-protein (BGP), and urinary hydroxyproline/creatinine (HOP/Cr) were measured every 6 months. In both studies, the Valid Completers (VC) analysis showed a maintenance of bone mass in ipriflavone-treated women, whereas in the placebo group, bone mineral density (BMD) was significantly decreased. The final outcome was a bone-sparing effect of 1.6% in study A, and of 3.5% in study B after 2 years. The Intention to Treat (ITT) analysis confirmed the decrease in the placebo group, with no changes in ipriflavone-treated women. A significant (P <0.05) between treatment difference was found in both studies. Biochemical markers of bone turnover decreased in patients treated with ipriflavone, thus suggesting a reduction of bone turnover rate. Twenty- six women treated with ipriflavone and 28 receiving the placebo dropped out because of side effects, mainly gastrointestinal. The compliance to the oral longterm treatment was good. The results of these studies show that ipriflavone is able to prevent both axial and peripheral bone loss in PMW with low bone mass, and is well tolerated.

Original languageEnglish
JournalCalcified Tissue International
Volume61
Issue numberSUPPL. 1
DOIs
Publication statusPublished - 1997

Keywords

  • Bone mass
  • Ipriflavone
  • Postmenopausal osteopenia

ASJC Scopus subject areas

  • Endocrinology

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    Gennari, C., Adami, S., Agnusdei, D., Bufalino, L., Cervetti, R., Crepaldi, G., Di Marco, C., Di Munno, O., Fantasia, L., Isaia, G. C., Mazzuoli, G. F., Ortolani, S., Passeri, M., Serni, U., & Vecchiet, L. (1997). Effect of chronic treatment with ipriflavone in postmenopausal women with low bone mass. Calcified Tissue International, 61(SUPPL. 1). https://doi.org/10.1007/s002239900380