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Merck's odanacatib increased BMD over 2 years at key fracture sites in Phase IIB study
Date:9/16/2008

umbar spine. Secondary endpoints included the LS mean change from baseline in BMD at the total hip, femoral neck, hip trochanter, and distal forearm, and changes in bone turnover based on biochemical markers.

"Bone mineral density" or BMD is the amount of mineralized bone tissue in a certain volume of bone and is one non-invasive measure used to help determine a patient's fracture risk. Odanacatib increased BMD

In the study, once-weekly treatment with 10, 25 and 50 mg of odanacatib significantly increased BMD at the lumbar spine, total hip and femoral neck at 24 months compared to baseline values. The 50 mg dose (n=58) resulted in LS mean percent increases in BMD of

5.48 percent at the lumbar spine compared to baseline values while treatment with placebo (n=61) resulted in a decrease of 0.19 percent compared to baseline (p=0.001). Similarly, the 50 mg dose resulted in LS mean percent increases in BMD of 3.16 percent at the total hip and 3.84 percent at the femoral neck compared to baseline values while treatment with placebo resulted in decreases of 0.93 percent and 0.85 percent respectively compared to baseline (p=0.001). Treatment with 3 mg odanacatib resulted in decreases in BMD at the lumbar spine, total hip and femoral neck. Changes in bone resorption and bone formation

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 50 mg of odanacatib resulted in decreases from baseline of 51.83 percent in uNTx and 30.57 percent in sCTx (p=0.001). sCTx and uNTx changes for placebo were an increase of 32.77 percent and a decrease of 4.62 percent respectively.

Treatment with the 50 mg 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 baseli
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Contact: Ron Rogers
908-423-6449
Merck & Co., Inc.
Source:Eurekalert

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