BMD Efficacy and Safety of Odanacatib in Postmenopausal Women
Information source: Merck
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Osteoporosis
Intervention: Comparator: Odanacatib (Drug); Comparator: Placebo (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Merck Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck
Overall contact:
Toll Free Number, Phone: 1-888-577-8839
Summary
This study will evaluate the safety and treatment effect of 50 mg MK0822 with Vitamin D vs
placebo with Vitamin D in postmenopausal women with low bone density.
Clinical Details
Official title: A Phase III Randomized, Placebo-Controlled Study to Evaluate the Effect of Odanacatib (MK0822) on Bone Mineral Density (BMD) and Overall Safety, and to Estimate the Effect of Odanacatib (MK0822) on Bone Micro-Architecture in Postmenopausal Women Treated With Vitamin D
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: To assess the safety and tolerability of MK0822 50 mg as compared with placebo
Secondary outcome: To evaluate the percent change from baseline in areal BMD at the lumbar spine (assessed by DXA)
Eligibility
Minimum age: 45 Years.
Maximum age: 85 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Postmenopausal for 3 years, hips contain no hardware from orthopedic procedures,
ambulatory
Exclusion Criteria:
- Patient has had a previous hip fracture
- Patient has had 1 prior clinical vertebral fracture
- Patient has been treated with oral bisphosphonates
- Patient has had metabolic bone disorder other than osteoporosis
- Patient has renal stones, Parkinson's disease, MS or active parathyroid disease
Locations and Contacts
Toll Free Number, Phone: 1-888-577-8839
Merck Sharp & Dohme (Australia) Pty Ltd., South Granville NSW 2142, Australia; Recruiting
David Woolner, Phone: 64-9-523-6075
Laboratoires Merck Sharp & Dohme - Chibret, Paris Cedex 8 75114, France; Recruiting
Jean-Marie Goehrs, Phone: 33-1-4754-89-90
Merck Frosst Canada Ltd., Kirkland, Quebec H9H 3L1, Canada; Recruiting
Michel Cimon, Phone: 514-428-2605
Additional Information
Starting date: October 2008
Ending date: February 2011
Last updated: October 29, 2008
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