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Phase III Data Published for Once Monthly Dose of Risedronate to Treat Postmenopausal Osteoporosis
Date:1/14/2008

BRIDGEWATER, N.J. and CINCINNATI, Jan. 14 /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 published this month in the January issue of the peer- reviewed journal Bone. In the non-inferiority study comparing risedronate 150 mg once monthly to risedronate 5 mg 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 150 mg once monthly and the 5 mg 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.

"Our goal is to provide patients with convenient dosing options for risedronate," said Nora Zorich, M.D., Ph.D., Vice President, Global R&D, P&G Pharmaceuticals. "If this dose regimen is approved, there will be a once monthly dose option available to patients seeking less frequent dosing of risedronate."

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 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
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SOURCE Procter & Gamble
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