Risedronate once a week.
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.
Adis International Inc., Yardley, Pennsylvania, 19067, USA. demail@adis.com
Ngaire J
NJ
White
Caroline M
CM
Perry
D015519:Bone Density / Q000187:drug effects; D002121:Calcium Channel Blockers / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use; D004334:Drug Administration Schedule; D012968:Etidronic Acid / Q000008:administration & dosage* / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000493:pharmacokinetics / Q000627:therapeutic use; D005260:Female; D006801:Humans; D015337:Multicenter Studies as Topic; D015663:Osteoporosis, Postmenopausal / Q000188:drug therapy*; D016032:Randomized Controlled Trials as Topic; D000068296:Risedronic Acid; D016103:Spinal Fractures / Q000517:prevention & control
D002121:Calcium Channel Blockers; D000068296:Risedronic Acid; D012968:Etidronic Acid