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Study to Determine the Efficacy and Safety of Romosozumab in the Treatment of Postmenopausal Women With Osteoporosis

NCT01631214 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 4093

Last updated 2025-02-21

Study results available
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Summary

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

Conditions

  • Postmenopausal Women With Osteoporosis

Interventions

BIOLOGICAL

Romosozumab

Romosozumab 210 mg administered by subcutaneous injection once a month during the double-blind treatment phase.

DRUG

Alendronate

Alendronate 70 mg tablet taken once a week

DRUG

Placebo to Romosozumab

Administered by subcutaneous injection once a month during the double-blind treatment phase.

DRUG

Placebo to Alendronate

Matching placebo tablet taken once a week during the double-blind treatment phase.

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
2012-05-04
Primary Completion
2017-02-27
Completion
2017-06-29

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Belgium
  • Brazil
  • Bulgaria
  • Canada
  • Chile
  • Colombia
  • Czechia
  • Denmark
  • Dominican Republic
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Guatemala
  • Hong Kong
  • Hungary
  • Ireland
  • Israel
  • Italy
  • Latvia
  • Lithuania
  • Mexico
  • Netherlands
  • New Zealand
  • Norway
  • Peru
  • Poland
  • Romania
  • Russia
  • Slovakia
  • South Africa
  • South Korea
  • Spain
  • Sweden
  • Taiwan
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

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Entities

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 NCT01631214 on ClinicalTrials.gov