Merck Press Release (07/11/12)
Merck has announced that the Data Monitoring Committee (DMC) for the Phase III trial assessing fracture risk reduction with odanacatib, Merck's investigational cathepsin K inhibitor, has completed its first planned interim analysis for efficacy. The DMC recommended that the study be closed early due to evidence of robust efficacy and the treatment's favorable benefit-risk profile, but noted that safety issues remained in certain areas and offered recommendations for following up on these issues. Merck will proceed with the planned blinded extension trial in order to continue monitoring these issues and further measure the efficacy of odanacatib. Investigators will schedule final assessments for the over 16,000 trial participants with data from the visits to be collected and reviewed prior to the final analysis. It is expected that final results will be submitted for presentation and publication in 2013.