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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01120600 |
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Date of registration:
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07/05/2010 |
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Primary sponsor: |
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Public title:
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A Study to Assess Safety and Efficacy of Odanacatib (MK-0822) in Men With Osteoporosis (MK-0822-053 AM1)
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Scientific title:
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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 |
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Date of first enrolment:
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July 2010 |
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Target sample size:
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266 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01120600 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Countries of recruitment
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Chile
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Colombia
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Denmark
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Estonia
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France
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Italy
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Japan
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Latvia
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Mexico
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Netherlands
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Russian Federation
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United Kingdom
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United States
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Has osteoporosis
- Has anatomy suitable for dual energy x-ray absorptiometry (DXA) scan of the lumbar
spine and and hip
- Is ambulatory
Exclusion Criteria:
- Is currently on oral bisphosphonates or other treatment for osteoporosis
- Had previous hip fragility fracture and is a candidate for standard of care therapy
- Has had a fragility fracture (vertebral or non-vertebral fractures indicating reduced
bone strength) within 12 months
- Has had more then one previous vertebral fracture
- Has been diagnosed with metabolic bone disorder other than osteoporosis
- Is Vitamin D deficient
- Has a history of renal stones
- Has active parathyroid disease
- Has history of thyroid disease not well controlled by medication
- Is diagnosed with secondary osteoporosis
- Has a daily calcium intake of <1,200 mg and is unwilling to take study prescribed
supplements or increase dietary intake, such that his daily calcium intake is at
least 1200 mg
- Has a history of malignancy =5 years prior to signing informed consent
- Has been diagnosed with hypogonadism due to causes that affect multiple organ and
body systems
Age minimum:
40 Years
Age maximum:
95 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Osteoporosis
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Intervention(s)
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Drug: Odanacatib
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Drug: Placebo for Odanacatib
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Primary Outcome(s)
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Percent change from baseline in lumbar spine bone mineral density (BMD)
[Time Frame: Baseline and Month 24]
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Secondary Outcome(s)
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Log-transformed fraction of baseline serum C-Telopeptides of Type 1 collagen (s-CTx) and urine N-Telopeptides of Type 1 collagen (u-NTx)
[Time Frame: Baseline and Month 24]
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Percent change from baseline in total hip, femoral neck, and trochanter BMD
[Time Frame: Baseline and Month 24]
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Secondary ID(s)
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2010_532
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MK0822-053
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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