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.

Condition	Intervention	Phase
Acute, closed distal radius fractures	Drug: rhBMP-2/CPM	Phase I

Further Study Details: 

Primary Outcomes: Determine the safety of administering rhBMP-2/CPM to subjects with distal radius fractures that require surgical fixation.
Secondary Outcomes: Feasibility of the test article injection procedure and localization of the test article relative to the distal radius fracture site.
Expected Total Enrollment:  40

Ages Eligible for Study:  50 Years   -   80 Years,  Genders Eligible for Study:  Both

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.

Please refer to this study by ClinicalTrials.gov identifier  NCT00161629

Trial Manager       clinicaltrialinfo@wyeth.com

Finland
      Turku,  20520,  Finland; Recruiting
      Kuopio,  70211,  Finland; Recruiting
      Oulu,  70211,  Finland; Recruiting
France
      Creteil,  94010,  France; Recruiting
      Paris,  75651,  France; Recruiting
      Paris,  75012,  France; Recruiting
      Paris,  75970,  France; Recruiting

Study chairs or principal investigators

Medical Monitor,  Study Director,  Wyeth Research   

Study ID Numbers:  3100N7-114
Last Updated:  September 11, 2005
Record first received:  September 1, 2005
ClinicalTrials.gov Identifier:  NCT00161629
Health Authority: Finland: Ethics Committee; France: Ministry of Health
ClinicalTrials.gov processed this record on 2005-09-13