- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00533650
Proof of Concept (Bone Resorption/Bone Mineral Density) Study (0429-005)
July 28, 2016 updated by: Merck Sharp & Dohme LLC
A study to asses the safety and efficacy of MK0429 in postmenopausal women with osteoporosis.
Study Overview
Study Type
Interventional
Enrollment (Actual)
227
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2000
Primary Completion (Actual)
October 1, 2002
Study Completion (Actual)
October 1, 2002
Study Registration Dates
First Submitted
September 19, 2007
First Submitted That Met QC Criteria
September 19, 2007
First Posted (Estimate)
September 21, 2007
Study Record Updates
Last Update Posted (Estimate)
July 29, 2016
Last Update Submitted That Met QC Criteria
July 28, 2016
Last Verified
May 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0429-005
- 2007_620
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Post-Menopausal Osteoporosis
-
Hoffmann-La RocheCompletedPost Menopausal OsteoporosisAustralia, United Kingdom, United States, Brazil, Germany, South Africa, France, Spain, Switzerland, Italy, Canada, Hungary, Belgium, Mexico, Poland, Denmark, Norway, Czechia, Romania
-
University College, LondonWithdrawnPost-menopausal OsteoporosisUnited Kingdom
-
Hoffmann-La RocheCompletedPost Menopausal OsteoporosisPhilippines, Taiwan, Thailand, Hong Kong, Indonesia
-
Hoffmann-La RocheCompletedPost Menopausal OsteoporosisUnited States, Puerto Rico
-
Hoffmann-La RocheCompletedPost Menopausal OsteoporosisBosnia and Herzegovina
-
NovartisCompletedPost-menopausal OsteoporosisGermany, Denmark
-
Centre Hospitalier Universitaire de Saint EtienneMinistry of Health, FranceRecruitingPost Menopausal OsteoporosisFrance
-
AmgenCompletedPost Menopausal OsteoporosisFrance
-
Hoffmann-La RocheCompletedPost Menopausal OsteoporosisUnited States
-
Hoffmann-La RocheCompletedPost Menopausal OsteoporosisSpain, South Africa, Germany, Mexico, United States, Canada, France, United Kingdom, Italy, Belgium, Australia, Poland, Denmark, Hungary, Czech Republic, Norway
Clinical Trials on MK0429
-
Merck Sharp & Dohme LLCCompletedProstatic Neoplasms