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Study Evaluating rhBMP-2/CPM in Closed Distal Radius Fractures

This study has been completed.
Study NCT00161629.   Last updated on December 3, 2007.   Information provided by Wyeth

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Descriptive Information Fields
Brief Title  Study Evaluating rhBMP-2/CPM in Closed Distal Radius Fractures
Official Title  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
Brief Summary

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.

Detailed Description
Study Phase Phase I
Study Type  Interventional
Study Design  Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety Study
Primary Outcome Measure  Determine the safety of administering rhBMP-2/CPM to subjects with distal radius fractures that require surgical fixation.
Secondary Outcome Measure  Feasibility of the test article injection procedure and localization of the test article relative to the distal radius fracture site.
Condition  Radius Fractures
Intervention  Drug: rhBMP-2/CPM
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Completed
Enrollment  40
Start Date  September 2005
Completion Date January 2007
Eligibility Criteria 

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.

Gender Both
Ages 50 Years to 80 Years
Accepts Healthy Volunteers No
Contacts ††
Location Countries  Finland,   France
Administrative Information Fields
NCT ID  NCT00161629
Organization ID 3100N7-114
Secondary IDs ††
Study Sponsor  Wyeth
Collaborators ††
Investigators 
Study Director:     Medical Monitor     Wyeth    
Principal Investigator:     Trial Manager     For Finland, MedInfoNord@wyeth.com    
Information Provided By Wyeth
Verification Date December 2007
First Received Date  September 1, 2005
Last Updated Date December 3, 2007

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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