Status:
COMPLETED
A Study to Compare the Safety and Efficacy of Romosozumab (AMG 785) Versus Placebo in Men With Osteoporosis
Lead Sponsor:
Amgen
Conditions:
Osteoporosis in Men
Eligibility:
MALE
55-90 years
Phase:
PHASE3
Brief Summary
The study is designed to evaluate if treatment with romosozumab once a month for 12 months compared with placebo is effective in increasing bone mineral density (BMD) at the lumbar spine. Additionally...
Eligibility Criteria
Inclusion
- Must be ambulatory male subjects ≥ 55 years to ≤ 90 years of age
- Must have a BMD T score ≤ -2.50 at the spine or hip, or BMD T score ≤ -1.50 at the spine or hip and a history of fragility nonvertebral fracture or vertebral fracture.
Exclusion
- A BMD T score ≤ -3.50 at the hip,
- History of hip fracture
- Severe metabolic bone diseases
- Significant laboratory abnormalities
- Recent treatment with agents affecting bone metabolism
Key Trial Info
Start Date :
June 16 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 20 2016
Estimated Enrollment :
245 Patients enrolled
Trial Details
Trial ID
NCT02186171
Start Date
June 16 2014
End Date
April 20 2016
Last Update
May 28 2019
Active Locations (34)
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1
Research Site
Lakewood, Colorado, United States, 80227
2
Research Site
Bethesda, Maryland, United States, 20817
3
Research Site
Albuquerque, New Mexico, United States, 87106
4
Research Site
Genk, Belgium, 3600