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news.Merck & Co has announced positive results of a new study in which its investigational selective cathepsin K inhibitor odanacatib reduced measures of bone turnover in women with breast cancer that has spread to the bones.
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In this study, treatment with oral odanacatib 5mg once daily reduced the level of urinary N-telopeptide (uNTx), a commonly used marker of bone resorption (breakdown), by 77% from baseline levels over four weeks. These results were seen as early as day seven, the first measurement point. Treatment with intravenous zoledronic acid 4mg (n=14) reduced uNTx by 73%.
In addition, responses to other markers of bone turnover, including the marker of bone resorption urinary deoxpyridinoline, the marker of bone formation serum bone-specific alkaline phosphatase and the marker of cathepsin K activity serum crosslinked C-terminal peptide were evaluated in the study.
This randomized, double-blind, multicenter study included 43 women with breast cancer and metastatic bone disease who received oral odanacatib 5mg daily or intravenous zoledronic acid 4mg on day one. The mean age of women was 60 years. The primary endpoints of the study were the marker of bone resorption urinary N-telopeptide of type I collagen corrected for creatinine (uNTx; pmol BCE/micromol creatinine) and safety.
Christopher Wynne, study investigator, said: “These findings show that odanacatib reduced several well-characterized biochemical markers of bone turnover in cancer patients with metastasis to bone, indicating this investigational medicine has the potential to slow the accelerated rate of bone destruction associated with bone metastases.”