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A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Compare the Efficacy and Safety of Romosozumab With Placebo in Men With Osteoporosis
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, the study will assess the effect of treatment with romosozumab for 12 months compared with placebo on BMD at the femoral neck and total hip.
Age
55 - 90 years
Sex
MALE
Healthy Volunteers
No
Research Site
Lakewood, Colorado, United States
Research Site
Bethesda, Maryland, United States
Research Site
Albuquerque, New Mexico, United States
Research Site
Genk, Belgium
Research Site
Ghent, Belgium
Research Site
Leuven, Belgium
Research Site
Liège, Belgium
Research Site
Medellín, Antioquia, Colombia
Research Site
Bogota, Cundinamarca, Colombia
Research Site
Ostrava-Trebovice, Czechia
Start Date
June 16, 2014
Primary Completion Date
February 15, 2016
Completion Date
April 20, 2016
Last Updated
May 28, 2019
245
ACTUAL participants
Romosozumab
BIOLOGICAL
Placebo
DRUG
Lead Sponsor
Amgen
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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