Neoplasms

Symptoms and General Pathology

All Conditions

Skin and Connective Tissue Diseases

Musculoskeletal Diseases

Neoplasm Metastasis

Breast Neoplasms

Bone Diseases

Breast Diseases

Skin Diseases

Bone Density Conservation Agents

All Drugs and Chemicals

Zoledronic Acid

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.

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.

Single ZA 4 mg IV infusion at the start of treatment

Once-daily odanacatib 5 mg tablet for 4 weeks

Odanacatib

Once-daily odanacatib matching placebo for 4 weeks

Odanacatib matching placebo

Single IV infusion of ZA matching placebo given at the start of treatment

ZA matching placebo

Medical Monitor

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.

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

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)

https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

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.

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.

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.

Merck Sharp & Dohme LLC

All randomized participants who took at least one dose of study drug

Participants received a single IV infusion of ZA 4 mg at the start of treatment and a once-daily odanacatib matching placebo tablet for 4 weeks.

Single IV Infusion of ZA 4 mg

Participants received a once-daily odanacatib 5 mg tablet for 4 weeks and a single IV infusion of ZA matching placebo at the start of treatment.

Once-daily Odanacatib 5 mg

Total

Age, Continuous

Sex: Female, Male

Senior Vice President, Global Clinical Development

All randomized participants who took at least one dose of study drug and had available u-NTx data for Baseline and Week 4

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

Number of Participants Who Experienced an Adverse Event (AE)

Number of Participants Who Discontinued Treatment Due to an AE

All randomized participants who took at least one dose of study drug and had available u-DPD data for Baseline and Week 4

Spots Global Cancer Trial Database for odanacatib matching placebo