Phase III Data Published for Once Monthly Dose of Risedronate to Treat Postmenopausal Osteoporosis
BRIDGEWATER, N.J. and CINCINNATI, January 14, 2008 /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 (1,000 mg) and vitamin D (400-1000 IU). The primary efficacy objective of the study was to demonstrate non-inferiority of the risedronate 150 mg monthly regimen to the risedronate 5 mg daily regimen as assessed by percent change from baseline in LS BMD at 12 months. The 24 month results will be reported at a later time. At 12 months, the mean LS BMD increases were 3.54% and 3.43% for the monthly and daily regimens, respectively. The most common adverse events reported in this study for the once monthly vs. daily dosing regimens, respectively, were upper abdominal pain (8.2% vs. 6.1%), diarrhea (8.2% vs. 4.7%), constipation (5.8% vs. 7.3%), influenza (8.9% vs. 4.2%) and arthralgia (5.5% vs. 7.3%).
The trial was sponsored by The Alliance for Better Bone Health.
About The Alliance for Better Bone Health
The Alliance for Better Bone Health was formed in May 1997 to promote bone health and disease awareness through numerous activities to support physicians and patients around the globe. It is a collaboration between Procter & Gamble Pharmaceuticals and sanofi-aventis U.S.
About Procter & Gamble
Three billion times a day, P&G brands touch the lives of people around the world. The company has one of the strongest portfolios of trusted, quality, leadership brands, including Pampers(R), Tide(R), Ariel(R), Always(R), Whisper(R), Pantene(R), Mach3(R), Bounty(R), Dawn(R), Gain(R), Pringles(R), Folgers(R), Charmin(R), Downy(R), Lenor(R), Iams(R), Crest(R), Oral-B(R), Actonel(R), Duracell(R), Olay(R), Head & Shoulders(R), Wella(R), Gillette(R), and Braun(R). The P&G community consists of 138,000 employees working in over 80 countries worldwide. Please visit http://www.pg.com for the latest news and in-depth information about P&G and its brands.
Sanofi-aventis, a leading global pharmaceutical company, discovers, develops and distributes therapeutic solutions to improve the lives of everyone. Sanofi-aventis is listed in Paris and in New York .
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CONTACT: Paula Koenigs of Procter & Gamble Pharmaceuticals,+1-513-622-3923, ; Terri Pedone of sanofi-aventis U.S.,+1-908-981-6562, ; Angela Collom,+1-215-928-2188, , or Kate Gormley, +1-215-928-2720,, both of Dorland Global Public Relations, for Procter& Gamble firstname.lastname@example.org email@example.com firstname.lastname@example.org email@example.com
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Posted: January 2008