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Phase 3 Trial of Odanacatib for Osteoporosis Is Halted Early After Drug Meets Efficacy Endpoints
The randomized, placebo-controlled trial was designed to evaluate the efficacy and safety of odanacatib in reducing the risk of fracture in more than 1,600 postmenopausal women with osteoporosis. The trial started in 2007 and was expected to continue until hip fractures were reported in a total of 237 women. The interim analysis was conducted by the DMC as planned when 70% of the targeted number of hip fractures had been reported.
Final results of the study will be submitted for presentation and publication in 2013.
Odanacatib selectively inhibits cathepsin K, the primary enzyme in osteoclasts that digest proteins during bone resorption. This mechanism of action allows odanacatib to improve the balance between bone resorption and bone formation in osteopororsis.
For more information, visit the Reuters Web site.