Risedronate Once A Week

Abstract

Risedronate (risedronic acid), an orally administered pyridinyl bisphosphonate, inhibits osteoclast-mediated resorption of bone and modulates bone metabolism in women with postmenopausal osteoporosis. The long terminal exponential half-life of risedronate (480 hours) has led to the development of a 35mg tablet for once-a-week administration. The beneficial effects of risedronate 35mg once a week on total hip, femoral neck and trochanter bone mineral density (BMD) at 12 months were similar to those of risedronate 5mg once daily. Risedronate 35mg once a week was as effective as risedronate 5mg once daily in improving lumbar spine BMD in a randomized, double-blind, multicenter trial of 1456 women with postmenopausal osteoporosis. Mean percentage increases in BMD from baseline at 12 months were 3.94% and 4.25% in the 35mg and 50mg once-a-week dose groups, compared with 4% in the 5mg once-daily dose group. The differences between the once-a-week doses and the once-daily dose met the predetermined criterion for non-inferiority. An historical analysis suggested that risedronate 35mg once a week reduced the incidence of vertebral fracture significantly more than placebo. The tolerability profile (including the incidence of upper gastrointestinal adverse events) of risedronate 35mg once a week in women with postmenopausal osteoporosis, was similar to that of risedronate 5mg once daily.