At a glance
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A Phase II Study to Assess the Safety, Tolerability, and Efficacy of MK-0822 (Cathepsin-K Inhibitor) in the Treatment of Women With Breast Cancer and Established Bone Metastases (MBD)
In Brief
A Phase 2 clinical trial evaluating ZA, Odanacatib, and 2 other interventions for Breast Cancer and Metastatic Bone Disease. Completed, enrolled 43 participants.
Detailed Summary
This is a 4-week study to examine the effects of a new experimental medication on women with breast cancer and established bone metastases. This study will enroll approximately 45 women. The primary hypotheses are: (1) odanacatib will result in a substantial suppression of urinary N-telopeptide of type I collagen (u-NTx) similar to that achieved with an intravenous (IV) infusion of zoledronic acid (ZA) over 4 weeks of treatment; and (2) odanacatib (MK-0822) will be safe and well tolerated during 4 weeks of treatment.
Study Details
Timeline
Interventions
Single ZA 4 mg IV infusion at the start of treatment
Once-daily odanacatib 5 mg tablet for 4 weeks
Once-daily odanacatib matching placebo for 4 weeks
Single IV infusion of ZA matching placebo given at the start of treatment