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Study To Assess FRacTure Healing With SclerosTin Antibody - Hip

NCT01081678 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 332

Last updated 2022-09-21

Study results available
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Summary

This is an international, multi-center study to determine the efficacy, safety, and tolerability of romosozumab (AMG 785) in adults with a fresh unilateral hip fracture, status post surgical fixation.

Conditions

  • Fracture Healing

Interventions

DRUG

Placebo

Administered by subcutaneous (under the skin) injection

DRUG

Romosozumab

Administered by subcutaneous injection

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
95 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-20
Primary Completion
2012-06-30
Completion
2013-05-10

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Bulgaria
  • Canada
  • Denmark
  • Estonia
  • Finland
  • Germany
  • Greece
  • Hong Kong
  • Hungary
  • India
  • Italy
  • Latvia
  • Lithuania
  • Netherlands
  • New Zealand
  • Poland
  • Slovenia
  • Sweden
  • 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 NCT01081678 on ClinicalTrials.gov