This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00399802
First received: November 14, 2006
Last updated: February 12, 2015
Last verified: February 2015
  Purpose
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.

Condition Intervention Phase
Breast Cancer Metastatic Bone Disease Drug: Odanacatib Drug: Comparator: zoledronic acid Drug: Comparator: Placebo (unspecified) Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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)

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • suppression of urinary N-telopeptide / safety and tolerability [ Time Frame: 4 Weeks ]

Secondary Outcome Measures:
  • urinary deoxypyridinoline [ Time Frame: 4 Weeks ]

Enrollment: 45
Study Start Date: November 2006
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Arm 1: odanacatib 50 mg tablet once weekly; one time zoledronic acid 4 mg IV infusion.
Drug: Odanacatib
odanacatib 50 mg tablet once weekly, 4 week treatment period.
Other Name: MK0822
Drug: Comparator: zoledronic acid
one time zoledronic acid 4 mg IV infusion.
Other Name: Zometa®
2
Arm 2: odanacatib 50 mg tablet once weekly; one time zoledronic acid Pbo IV infusion.
Drug: Odanacatib
odanacatib 50 mg tablet once weekly, 4 week treatment period.
Other Name: MK0822
Drug: Comparator: Placebo (unspecified)
zoledronic acid Pbo IV infusion, 4 week treatment period.
3
Arm 3: odanacatib Pbo tablet once weekly; one time zoledronic acid 4 mg IV infusion.
Drug: Comparator: zoledronic acid
one time zoledronic acid 4 mg IV infusion.
Other Name: Zometa®
Drug: Comparator: Placebo (unspecified)
odanacatib Pbo tablet once weekly, 4 week treatment period.
4
Arm 4: odanacatib Pbo tablet once weekly; one time zoledronic acid Pbo IV infusion.
Drug: Comparator: Placebo (unspecified)
odanacatib Pbo tablet once weekly, 4 week treatment period.
Drug: Comparator: Placebo (unspecified)
zoledronic acid Pbo IV infusion, 4 week treatment period.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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 or bisphosphonate use within 6 months of entry into study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00399802

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00399802     History of Changes
Other Study ID Numbers: 0822-016
2006_533
MK-0822-016
Study First Received: November 14, 2006
Last Updated: February 12, 2015

Additional relevant MeSH terms:
Breast Neoplasms
Bone Diseases
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Musculoskeletal Diseases
Zoledronic acid
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 18, 2017