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Study of Romosozumab (AMG 785) in Tibial Diaphyseal Fractures Status Post Intramedullary Nailing

NCT00907296 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 402

Last updated 2022-09-22

Study results available
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Summary

The primary objective of this study is to investigate the effect of romosozumab compared with placebo on time to radiographic healing of fresh tibial diaphyseal fractures (fractures in the midsection of the shinbone).

Conditions

  • Fracture Healing

Interventions

BIOLOGICAL

Romosozumab

Administered by subcutaneous injection

DRUG

Placebo

Administered by subcutaneous injection

Sponsors & Collaborators

  • UCB Pharma

    collaborator INDUSTRY

  • Amgen

    lead INDUSTRY

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-02
Primary Completion
2012-03-06
Completion
2013-05-10

Countries

  • United States
  • Australia
  • Bulgaria
  • Canada
  • Denmark
  • Estonia
  • France
  • Germany
  • Greece
  • Hong Kong
  • Hungary
  • India
  • Italy
  • Latvia
  • Lithuania
  • Mexico
  • New Zealand
  • Norway
  • Poland
  • Romania
  • Russia
  • Slovakia
  • United Kingdom

Study Locations

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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 NCT00907296 on ClinicalTrials.gov