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Completed

NCT Number: NCT00399802

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

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.

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Key information

Conditions

Breast Cancer Bone Diseases Breast Diseases Breast Neoplasms Metastatic Bone Disease Musculoskeletal Diseases Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ZA

Drug

Single ZA 4 mg IV infusion at the start of treatment

Other names: Zometa®

odanacatib

Drug

Once-daily odanacatib 5 mg tablet for 4 weeks

Other names: MK-0822

Odanacatib matching placebo

Drug

Once-daily odanacatib matching placebo for 4 weeks

ZA matching placebo

Drug

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

Primary outcomes

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

    Time frame: Baseline and 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.

  2. Number of Participants Who Experienced an Adverse Event (AE)

    Time frame: Up to 6 weeks

    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.

  3. Number of Participants Who Discontinued Treatment Due to an AE

    Time frame: Up to 4 weeks

    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.

Secondary outcomes

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

    Time frame: Baseline and 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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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)

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Nov 15, 2006
Registry last updated
Aug 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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