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

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00399802

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 II

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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
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)

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. Drug: Comparator: zoledronic acid one time zoledronic acid 4 mg IV infusion.
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. 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. 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:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2006_533, MK0822-016
Study First Received:	November 14, 2006
Last Updated:	May 15, 2008
ClinicalTrials.gov Identifier:	NCT00399802 History of Changes
Health Authority:	Denmark: Danish Medicines Agency

Study placed in the following topic categories:

Zoledronic acid
Skin Diseases
Musculoskeletal Diseases
Neoplasm Metastasis

Breast Neoplasms
Bone Density Conservation Agents
Bone Diseases
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Zoledronic acid
Neoplasms by Site
Skin Diseases
Musculoskeletal Diseases
Physiological Effects of Drugs

Breast Neoplasms
Bone Density Conservation Agents
Bone Diseases
Pharmacologic Actions
Breast Diseases

ClinicalTrials.gov processed this record on May 07, 2009