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news.The Alliance for Better Bone Health, a collaboration between Procter & Gamble Pharmaceuticals and Sanofi-Aventis has reported positive Phase III clinical trial evaluating the efficacy and safety of risedronate 150mg once monthly for the treatment of postmenopausal osteoporosis.
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In the non-inferiority study comparing risedronate 150mg once monthly to risedronate 5mg daily, increases in lumbar spine bone mineral density (BMD) at one year were similar for patients taking either the monthly or daily dosing regimens. All patients were supplemented with calcium and vitamin D.
In the study, BMD was measured at the lumbar spine, total hip, femoral neck, and femoral trochanter. There were no statistically significant differences in BMD increases between the risedronate 150mg once monthly and the 5mg daily dose groups at 12 months at all sites. In the study, the tolerability and safety profiles also were generally similar for the monthly and daily dosing regimens of risedronate.