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Efficacy and Safety of Romosozumab Treatment in Postmenopausal Women With Osteoporosis

NCT01575834 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 7180

Last updated 2024-08-28

Study results available
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Summary

The purpose of this study is to determine if treatment with romosozumab is effective in preventing fractures in women with postmenopausal osteoporosis

Conditions

  • Postmenopausal Osteoporosis

Interventions

DRUG

Romosozumab

Administered by subcutaneous injection once a month (QM)

DRUG

Placebo

Administered by subcutaneous injection once a month (QM)

DRUG

Denosumab

Administered by subcutaneous injection once every 6 months (Q6M)

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-03-15
Primary Completion
2015-12-14
Completion
2016-12-28

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Brazil
  • Canada
  • Colombia
  • Czechia
  • Denmark
  • Dominican Republic
  • Estonia
  • Germany
  • Hungary
  • India
  • Japan
  • Latvia
  • Lithuania
  • Mexico
  • New Zealand
  • Poland
  • Romania
  • Spain
  • Switzerland
  • United Kingdom

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 NCT01575834 on ClinicalTrials.gov