New Phase III Data Presented for Once Monthly Dosing Regimen of Risedronate to Treat Postmenopausal Os... ( HONOLULU Sept. 19 /- Results from...)

New Phase III Data Presented for Once Monthly Dosing Regimen of Risedronate to Treat Postmenopausal Osteoporosis

Date:9/19/2007

HONOLULU, Sept. 19 /PRNewswire-FirstCall/ -- Results from a Phase III clinical trial evaluating the efficacy and safety of risedronate 150 mg once monthly for the treatment of postmenopausal osteoporosis were presented at the American Society for Bone and Mineral Research (ASBMR) 29th Annual Meeting. In the non-inferiority study comparing risedronate 150 mg once monthly to risedronate 5 mg daily [Actonel(R) (risedronate sodium tablets)] increases in bone mineral density (BMD) were similar for patients taking either the monthly or daily dosing regimens.

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 150 mg once monthly and the 5 mg daily dose groups at 12 months. In the study, the tolerability and safety profiles were also similar for the monthly and daily dosing regimens of risedronate.

"Risedronate is already approved to reduce the risk of both spinal and nonspinal fractures," said Michael McClung, M.D., Founding Director of the Oregon Osteoporosis Center in Portland, Oregon. "For patients who prefer less frequent dosing, risedronate 150 mg, if approved, would provide the convenience of a once monthly dosing option."

About the Study

The MERIT-OP (Monthly Evaluation of Risedronate Trial in Osteoporosis) study is a 2-year, randomized, double-blind, active-control (5 mg daily risedronate) clinical trial which evaluated 1,292 postmenopausal women (94% Caucasian) between 50 and 88 years old, mean age 64.9, from 47 clinical centers in 13 countries. The participants had osteoporosis, defined as a lumbar spine (LS) BMD T-score less than -2.5 or a LS BMD T-score less than - 2.0 and at least one prevalent vertebral fracture. Patients were randomized to dosing regimens of either risedronate 150 mg monthly or risedronate 5 mg daily and received daily supplements of calcium (1,000 mg) and vitamin D (400
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SOURCE The Alliance for Better Bone Health
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