A Study to Examine the Effects of an Experimental Drug on Women With Breast Cancer and Metastatic Bone Disease (MBD) - Full Text View

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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Bone Diseases Breast Cancer Cancer

Drug Information available for: Zoledronic acid

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

suppression of urinary N-telopeptide / safety and tolerability [ Time Frame: 4 Weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

urinary deoxypyridinoline [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]

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
Genders 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

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

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier:	NCT00399802 History of Changes
Other Study ID Numbers:	2006_533, MK0822-016
Study First Received:	November 14, 2006
Last Updated:	May 15, 2008
Health Authority:	Denmark: Danish Medicines Agency

Additional relevant MeSH terms:

Bone Diseases
Breast Neoplasms
Musculoskeletal Diseases
Neoplasms by Site
Neoplasms
Breast Diseases

Skin Diseases
Zoledronic acid
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013