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

Radius Fractures Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00161629
• Other study ID #: 3100N7-114
• Status: Completed
• Phase: Phase 1
• First received: September 1, 2005
• Last updated: December 3, 2007
• Start date: September 2005
• Est. completion date: January 2007

Study information

• Verified date: December 2007
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics CommitteeFrance: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fractures, Bone
• Radius Fractures

Intervention

Drug:
• rhBMP-2/CPM

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Countries where clinical trial is conducted

Finland,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the safety of administering rhBMP-2/CPM to subjects with distal radius fractures that require surgical fixation.
Secondary	Feasibility of the test article injection procedure and localization of the test article relative to the distal radius fracture site.