- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00161629
Study Evaluating rhBMP-2/CPM in Closed Distal Radius Fractures
December 3, 2007 updated by: Wyeth is now a wholly owned subsidiary of Pfizer
A Phase 1 Dose-Escalating, Double-Blind, Placebo-Controlled, Multicenter, Safety and Feasibility Study of Recombinant Human Bone Morphogenetic Protein-2 (rhBMP-2)/Calcium Phosphate Matrix (CPM) as an Adjuvant Therapy for Closed Distal Radius Fractures
To evaluate the safety of rhBMP-2/CPM administered to subjects presenting with closed distal radius fractures.
The key safety variables comprising this assessment are: 1) incidence of delayed union; 2) median time to fracture union (assessed by the investigators); 3) incidence of local neurovascular events (those involving the region under study [RUS]); and 4) rate of fracture displacement.
The primary objective will be met if these outcomes in the active and placebo treatment groups are at least comparable to those of the SOC control group.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
40
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
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
50 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Adults aged 50 to 80 years of age; alert and oriented to person, place, and time.
- Acute, closed distal radius fractures (within 4 cm of the tip of the radial styloid process), classified according to AO/ASIF as either A2 or A3 (extra-articular) or C1 or C2 (intra-articular) fractures.
- Closed fracture reduction and definitive fracture fixation performed within 7 days after injury by means of external skeletal and/or percutaneous pin fixation. Note: fractures that are initially treated by closed reduction and casting, then converted to external or percutaneous pin fixation for definitive fracture fixation within 7 days after injury are eligible for the study.
Other inclusion applies.
Exclusion Criteria:
- Other fractures of the ipsilateral upper extremity (except for ulnar styloid fractures) or the contralateral upper extremity (except for previously healed fractures without residual functional deficit).
- Fracture fixation by other means (eg, plate and screw fixation).
- Planned treatment for the fracture includes any procedure to promote fracture healing (eg, open reduction internal fixation, bone grafting, non-invasive modalities such as ultrasound, electrical stimulation, etc). Note: After 12 weeks have elapsed since administration of the treatment assignment, unanticipated procedures to promote fracture healing are permitted as clinically indicated.
Other exclusion applies.
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: Single Group Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Determine the safety of administering rhBMP-2/CPM to subjects with distal radius fractures that require surgical fixation.
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Secondary Outcome Measures
Outcome Measure |
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Feasibility of the test article injection procedure and localization of the test article relative to the distal radius fracture site.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Trial Manager, For Finland, MedInfoNord@wyeth.com
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
September 1, 2005
Study Completion (Actual)
January 1, 2007
Study Registration Dates
First Submitted
September 1, 2005
First Submitted That Met QC Criteria
September 7, 2005
First Posted (Estimate)
September 12, 2005
Study Record Updates
Last Update Posted (Estimate)
December 5, 2007
Last Update Submitted That Met QC Criteria
December 3, 2007
Last Verified
December 1, 2007
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3100N7-114
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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