WHITEHOUSE STATION (dpa-AFX) - Merck & Co. Inc. (MRK) said Saturday that data from a Phase II trial of odanacatib showed that the drug significantly increased Bone Mineral Density over a two-year period in post-menopausal osteoporotic women who previously had three or more years of treatment with alendronate.
The results were presented at the 34th Annual Meeting of the American Society for Bone and Mineral Research.
Odanacatib is an investigational cathepsin K (cat-K) inhibitor in development for the treatment of osteoporosis in post-menopausal women. In the study, patients were allowed to have been off alendronate therapy for up to three months immediately prior to enrollment in the study.
The 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 Bone Mineral Density, orBMD T-scores (?-2.5 and >-3.5) 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 for the femoral neck, hip trochanter, and total hip, respectively, compared with placebo), as well as for the lumbar spine. The difference versus placebo at the distal forearm (+0.22%) was not statistically significant.
The overall incidence of adverse events, including those that were considered drug-related or serious, were similar between treatment groups. Treatment discontinuations due to adverse events were 9.0 percent for patients receiving odanacatib and 3.3 percent for patients receiving placebo. The most common clinical adverse events in patients receiving odanacatib were urinary tract infection, back pain, arthralgia, fractures, bronchitis, among others.
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