Back to resultsProof of Concept (Bone Resorption/Bone Mineral Density) Study (0429-005)
Primary Purpose
Post-Menopausal Osteoporosis
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
MK0429
Sponsored by
About this trial
This is an interventional treatment trial for Post-Menopausal Osteoporosis
Eligibility Criteria
Inclusion Criteria:
- Person is a women with osteoporosis who is unwilling or unable to take other treatments for osteoporosis
Exclusion Criteria:
- Person has had a previous fracture
- Person has rheumatoid arthritis. Person has has certain types of cancer
- Person has donated blood or has been in another investigational study within the last 4 weeks
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00533650
First Posted
September 19, 2007
Last Updated
July 28, 2016
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00533650
Brief Title
Proof of Concept (Bone Resorption/Bone Mineral Density) Study (0429-005)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
December 2000 (undefined)
Primary Completion Date
October 2002 (Actual)
Study Completion Date
October 2002 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
5. Study Description
Brief Summary
A study to asses the safety and efficacy of MK0429 in postmenopausal women with osteoporosis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Menopausal Osteoporosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
227 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
MK0429
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Person is a women with osteoporosis who is unwilling or unable to take other treatments for osteoporosis
Exclusion Criteria:
Person has had a previous fracture
Person has rheumatoid arthritis. Person has has certain types of cancer
Person has donated blood or has been in another investigational study within the last 4 weeks
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Proof of Concept (Bone Resorption/Bone Mineral Density) Study (0429-005)
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