Conditions: Breast Cancer Metastatic Bone Disease
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 43
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Participants will receive a single IV infusion of ZA 4 mg at the start of treatment and a once-daily odanacatib matching placebo tablet for 4 weeks. arm 2: Participants will receive a once-daily odanacatib 5 mg tablet for 4 weeks and a single IV infusion of ZA matching placebo at the start of treatment.

Interventions: intervention 1: ZA intervention 2: Odanacatib intervention 3: Odanacatib matching placebo intervention 4: ZA matching placebo
Intervention descriptions: intervention 1: Single ZA 4 mg IV infusion at the start of treatment intervention 2: Once-daily odanacatib 5 mg tablet for 4 weeks intervention 3: Once-daily odanacatib matching placebo for 4 weeks intervention 4: Single IV infusion of ZA matching placebo given at the start of treatment

Protocol document: