A Study to Examine the Effects of an Experimental Drug on Women With Breast Cancer and Metastatic Bone Disease (MBD)(0822-016)(COMPLETED)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 2

Conditions: Breast Cancer; Metastatic Bone Disease

Treatments: Drug: Odanacatib; Drug: ZA; Drug: ZA matching placebo; Drug: Odanacatib matching placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00399802

0822-016

MK-0822-016 (Other Identifier)

2006_533 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 43 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient has histologically or cytologically-confirmed breast cancer
• Patient has documented skeletal metastases

Exclusion criteria

• Patient is undergoing current oral bisphosphonate therapy, or has a history of oral bisphosphonate use within 6 months of entry into study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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43 participants in 2 patient groups

Single IV infusion of ZA 4 mg

Active Comparator group

Description:

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.

Treatment:

Drug: Odanacatib matching placebo

Drug: ZA

Odanacatib 5 mg

Experimental group

Description:

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.

Treatment:

Drug: ZA matching placebo

Drug: Odanacatib