FDAnews
www.fdanews.com/articles/87307-procter-gamble-sanofi-aventis-report-risedronate-data

PROCTER & GAMBLE, SANOFI-AVENTIS REPORT RISEDRONATE DATA

June 5, 2006

Procter & Gamble and sanofi-aventis have reported that a recent Phase III trial of osteoporosis drug risedronate found a statistically significant 4.5 percent increase in bone density in men.

In the trial, patients treated with risedronate experienced statistically significant improvements in lumbar spine bone mineral density at all time points measured, 3, 6, 12, and 24 months. Overall, risedronate was well-tolerated, and adverse events were generally similar between patients receiving risedronate and patients receiving placebo.