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A Study to Compare the Safety and Efficacy of Romosozumab (AMG 785) Versus Placebo in Men With Osteoporosis

NCT02186171 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 245

Last updated 2019-05-28

Study results available
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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, 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.

Conditions

  • Osteoporosis in Men

Interventions

BIOLOGICAL

Romosozumab

Administered by subcutaneous injection once a month.

DRUG

Placebo

Administered by subcutaneous injection once a month.

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
90 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-16
Primary Completion
2016-02-15
Completion
2016-04-20

Countries

  • United States
  • Belgium
  • Colombia
  • Czechia
  • Denmark
  • Japan
  • Mexico
  • Poland
  • Russia
  • Switzerland

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02186171 on ClinicalTrials.gov