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Merck & Co Inc Announces Results From Phase II Trial For Odanacatib


Saturday, 13 Oct 2012 12:15pm EDT 

Merck & Co Inc announced results from a Phase II trial for odanacatib, an investigational cathepsin K (cat-K) inhibitor in development for the treatment of osteoporosis in post-menopausal women. In the study, treatment with odanacatib (compared to placebo) significantly increased Bone Mineral Density (BMD) over a two-year period in post-menopausal osteoporotic women who previously had three or more years of treatment with alendronate. Patients were allowed to have been off alendronate therapy for up to three months immediately prior to enrollment in the study. This study was a randomized, double-blind, placebo-controlled, multi-center, 24-month trial of odanacatib in 243 women with post-menopausal osteoporosis who had been previously treated with alendronate (dosed daily or weekly) for ≥3 years. Participants were at least 60 years of age with low BMD T-scores at any hip site (femoral neck, trochanter, or total hip) without a history of fragility fracture, or had BMD T-scores ≤-1.5 and > -3.5 at any hip site, with a history of fragility fracture (except hip fracture). In the odanacatib group, BMD changes from baseline at 24 months were significantly different versus placebo at all three hip sites (+1.73%, +1.83%, +0.83% for the femoral neck, hip trochanter, and total hip, respectively, vs. -0.94%, -1.35%, -1.87% with placebo), and the lumbar spine (+2.28% vs. -0.30% change with placebo). At the distal forearm, BMD changes from baseline at 24 months were -0.92% and -1.14%. 

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