A Study to Assess Safety and Efficacy of Odanacatib (MK-0822) in Men With Osteoporosis (MK-0822-053 AM1)



Status:Archived
Conditions:Osteoporosis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:Any
Updated:7/1/2011
Start Date:July 2010
End Date:May 2014

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A Phase III Randomized, Placebo-Controlled Clinical Trial to Assess the Safety and Efficacy of Odanacatib (MK-0822) in the Treatment of Men With Osteoporosis Treated With Vitamin D and Calcium


The purpose of this study is to test the hypothesis that treatment with odanacatib will
result in increased BMD (bone mineral density) compared to treatment with placebo. This
study will also evaluate the safety and efficacy of odanacatib for male osteoporosis
patients.


The original study was divided into two parts, with the primary analysis of endpoints to
occur at 24 months and the patients will then remain in the study for an additional 12
months (Part 2). Amendment 1 of the protocol removed the additional 12 month period and the
Month 36 BMD analysis was deleted.


We found this trial at
9
sites
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Portland, OR
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1200 Old York Road
Abington, Pennsylvania 19001
(215) 481–2000
Abington Memorial Hospital Abington Memorial Hospital (AMH) is a 665-bed, regional referral center and teaching...
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Abington, PA
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Abington, PA
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Albuquerque,, NM
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Baltimore, MD
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Falls Church, Virginia 22042
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Falls Church, VA
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Falls Church, VA
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Marshfield, WI
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New Britain, Connecticut 06052
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New Britain, CT
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