Phase III trial for Odanacitib(Merck Inc.) in Osteoporosis closes early

A Phase III randomized, placebo-controlled trial with over 16,000 patients is designed to assess the safety and efficacy of odanacatib (from Merck Inc.) in reducing fracture risk in post-menopausal women with Osteoporosis. This event-driven trial started in 2007 and was expected to continue until hip fractures had been reported in a total of 237 patients. The Data Monitoring Committee (DMC) has decided to close the trial due to robust efficacy and a favorable benefit-risk profile.

An interim analysis was conducted by the DMC as planned when approximately 70 percent of the targeted number of hip fractures had been reported. Merck expects the process of closing this large, multi-center trial to take a number of months. Data will be collected and reviewed to allow a full and complete analysis, and final results of the study will be submitted for presentation and publication in 2013 once the analysis is complete. Merck anticipates submitting regulatory applications for approval of odanacatib in the U.S., European Union and Japan in the first half of 2013.