Actonel indications extended in EU

Aventis has been granted an extension to the approved indications forits bisphosphonate Actonel (risedronate) in the European Union to include the reduction of hip fracture risk in women with established postmenopausal osteoporosis. The approval was based on new data from the Hip Intervention Program (HIP) study, showing that Actonel reduced the risk of hip fracture up to 60% in elderly women with established osteoporosis. Actonel is jointly marketed with Procter & Gamble.

Meanwhile, the results of a five-year study of Actonel have shown that the bisphosphonate cut the rate of vertebral fractures by 50% compared with placebo over this time period. Prior studies of drugs in this class have only documented fracture benefits versus control for up to four years.