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news.Merck & Co has announced that two-year data from a Phase IIB study of odanacatib, an investigational, selective cathepsin-K inhibitor in development for the treatment of osteoporosis, has demonstrated dose-dependent increases in bone mineral density at the total hip, lumbar spine and femoral neck fracture sites and decreased indices of bone resorption compared to placebo in postmenopausal women with low BMD.
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The multi-center, double-blind, randomized, placebo-controlled study evaluated doses of 3, 10, 25 or 50mg of odanacatib administered orally, once-weekly and without regard to the timing of meals or the patient’s physical position in 399 postmenopausal women with low bone mineral density (BMD) for 24 months. The primary study endpoint was the LS mean change in BMD from baseline at the lumbar spine.
In the study, once-weekly treatment with 10, 25 and 50mg of odanacatib significantly increased BMD at the lumbar spine, total hip and femoral neck at 24 months compared to baseline values. The 50mg dose (n=58) resulted in LS mean percent increases in BMD of 5.48% at the lumbar spine compared to baseline values while treatment with placebo (n=61) resulted in a decrease of 0.19% compared to baseline.
Similarly, the 50mg dose resulted in LS mean percent increases in BMD of 3.16% at the total hip and 3.84% at the femoral neck compared to baseline values while treatment with placebo resulted in decreases of 0.93% and 0.85% respectively compared to baseline. Treatment with 3mg odanacatib resulted in decreases in BMD at the lumbar spine, total hip and femoral neck.
The study also assessed biochemical markers of bone resorption including sCTx (serum C-terminal telopeptides of Type 1 collagen) and uNTx (urinary N-telopeptides/creatinine ratio). Treatment with 50mg of odanacatib resulted in decreases from baseline of 51.83% in uNTx and 30.57% in sCTx. sCTx and uNTx changes for placebo were an increase of 32.77% and a decrease of 4.62% respectively.
Treatment with the 50mg dose reduced biochemical markers of new bone formation including s-BSAP (bone specific alkaline phosphatase) and sP1NP (serum N-terminal propeptides of type 1 collagen). s-BSAP was reduced from baseline by 13.26% (p=0.002) and sP1NP was reduced by 20.20% from baseline (p=0.011). s-BSAP and sP1NP changes for placebo were increases of 3.38% and 1.29% respectively.