A Study of rhBMP-2/CPM in Closed Fractures of the Humerus

February 21, 2013 updated by: Wyeth is now a wholly owned subsidiary of Pfizer

A Phase 2, Multicenter, Double-Blind, Randomized, Stratified, Controlled, Efficacy, Safety and Feasibility Study of Recombinant Human Bone Morphogenetic Protein-2 (rhBMP-2)/Calcium Phosphate Matrix (CPM) as an Adjuvant Therapy in Closed Fractures of the Humerus

The primary objective of this study is to assess whether fracture union is accelerated in subjects with humeral fractures (proximal,diaphyseal) treated with conservative therapy (standard of care) and a single dose of rhBMP-2/CPM compared to subjects who receive standard of care alone.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

139

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Queensland
      • Herston, Queensland, Australia, 4029
    • South Australia
      • Adelaide, South Australia, Australia, 5000
    • Victoria
      • Melbourne, Victoria, Australia, 3004
  • Brazil
      • Sao Paulo, Brazil, 08270-070
      • Sao Paulo, Brazil, 04020-060
      • São Paulo, Brazil, 08270-070
  • Canada
      • Charlottetown, Canada, C1A8T5
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 1Y6
    • Ontario
      • Ajax, Ontario, Canada, L157J5
      • Chatham, Ontario, Canada, N7M 5L9
      • Oshawa, Ontario, Canada, L1G 2B9
      • Scarborough, Ontario, Canada, M1E 4B9
      • Windsor, Ontario, Canada, N9A 1E1
    • Quebec
      • Montreal, Quebec, Canada, H4J 1C5
  • Finland
      • Oulu, Finland, 9002
      • Turku, Finland, 20520
  • France
      • Angers, France, 49100
      • Creteil, France, 94010
  • Germany
      • Berlin, Germany, 13353
      • Muenster, Germany, 48149
  • Mexico
      • Chihuahua, Mexico, 31020
      • D.f., Mexico, 11250
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44280
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico, 64460
  • Norway
      • Oslo, Norway, NO-0407
  • Romania
      • Bucharest, Romania, 14461
      • Bucharest, Romania, 21659
      • Bucharest, Romania, 50098
  • Sweden
      • Linköping, Sweden, SE-581 85
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
    • Colorado
      • Aurora, Colorado, United States, 80012
      • Denver, Colorado, United States, 80204
    • Florida
      • Clearwater, Florida, United States, 33756
      • St. Petersburg, Florida, United States, 33781
    • New York
      • Brooklyn, New York, United States, 11220
    • North Carolina
      • Monroe, North Carolina, United States, 28112
    • Ohio
      • Toledo, Ohio, United States, 43606
    • Pennsylvania
      • State College, Pennsylvania, United States, 16801

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Skeletally mature subjects age 18 years or older.
  • Subjects with either a closed proximal humeral fracture or a diaphyseal humeral fracture.
  • Treatment plan that includes only conservative (nonoperative) therapy within 48 hours following injury.

Exclusion Criteria:

  • Shoulder dislocation at the time of injury.
  • Planned procedure(s) at that would stimulate fracture union at the time of application of the initial immobilization device.
  • Fractures located in the distal third of humerus.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
1.0 mg/mL rhBMP-2/CPM + SOC
Drug: rhBMP-2/CPM
Experimental: B
2.0 mg/mL rhBMP-2/CPM + SOC
Drug: rhBMP-2/CPM
Active Comparator: C
Buffer/CPM + SOC
Drug: rhBMP-2/CPM
Other: D
Standard of Care Alone (SOC)
Drug: rhBMP-2/CPM

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary efficacy variable in this study is radiographic union.
Time Frame: Fracture union is assessed at 4, 6, 8, 10, 12, 16, 26 and 52 week visits. The goal of acceleration of fracture union will be met if median time to radiographic fracture union is decreased by 4 weeks in an active treatment arm compared to SOC alone.
Fracture union is assessed at 4, 6, 8, 10, 12, 16, 26 and 52 week visits. The goal of acceleration of fracture union will be met if median time to radiographic fracture union is decreased by 4 weeks in an active treatment arm compared to SOC alone.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Investigators

  • Principal Investigator: Trial Manager, For Brazil, xavierl@wyeth.com
  • Principal Investigator: Trial Manager, For Mexico, gomezzlj@wyeth.com

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

October 3, 2006

First Submitted That Met QC Criteria

October 3, 2006

First Posted (Estimate)

October 6, 2006

Study Record Updates

Last Update Posted (Estimate)

February 28, 2013

Last Update Submitted That Met QC Criteria

February 21, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3100N7-212

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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