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 LLC43 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Breast Cancer Metastatic Bone Disease

Interventions

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Percentage Change From Baseline in Urinary N-telopeptide of Type I Collagen (u-NTx) at Week 4

u-NTx is a biochemical index of bone resorption. Participants provided urine specimens on Day 1 (baseline) and at Week 4 for measurement of u-NTx.

Time frame: Baseline and Week 4

Number of Participants Who Experienced an Adverse Event (AE)

An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.

Time frame: Up to 6 weeks

Number of Participants Who Discontinued Treatment Due to an AE

Time frame: Up to 4 weeks

Secondary Outcomes

Percentage Change From Baseline in Urinary Deoxypyridinoline (u-DPD) at Week 4

u-DPD is a biochemical marker of bone resorption. Participants provided urine specimens on Day 1 (baseline) and Week 4 for measurement of u-DPD.

Time frame: Baseline and Week 4