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

NCT00161629 | Completed Phase 1

• 1 other identifier: 3100N7-114
• Study Type: interventional
• Target: 40
• Locations: 2 countries
• Sites: 7

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.

Conditions

Radius Fractures

Keywords

Distal Radius Fractures

Outcome Measures

Primary Outcomes (1)

• Determine the safety of administering rhBMP-2/CPM to subjects with distal radius fractures that require surgical fixation.

Secondary Outcomes (1)

• Feasibility of the test article injection procedure and localization of the test article relative to the distal radius fracture site.

Interventions

rhBMP-2/CPM DRUG

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wyeth is now a wholly owned subsidiary of Pfizer: lead

Study Sites (7)

Unknown Facility

Kuopio, 70211, Finland

Location

Unknown Facility

Oulu, 70211, Finland

Location

Unknown Facility

Turku, 20520, Finland

Location

Unknown Facility

Créteil, 94010, France

Location

Unknown Facility

Paris, 75012, France

Location

Unknown Facility

Paris, 75651, France

Location

Unknown Facility

Paris, 75970, France

Location

MeSH Terms

Conditions

Radius Fractures; Wrist Fractures

Condition Hierarchy (Ancestors)

Forearm Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone; Wrist Injuries

Study Officials

• Medical Monitor

  Wyeth is now a wholly owned subsidiary of Pfizer

  STUDY DIRECTOR

• Trial Manager

  For Finland, MedInfoNord@wyeth.com

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 1, 2005
• First Posted: September 12, 2005
• Study Start: September 1, 2005
• Study Completion: January 1, 2007
• Last Updated: December 5, 2007

Record last verified: 2007-12

Locations

FI (3); FR (4)