Study Evaluating rhMBP-2/CPM in Open Wedge Osteotomies

Phase 1

Completed

• Conditions: Osteoarthritis

• Registration Number: NCT00243295
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

To assess the feasibility of using rhBMP-2/CPM in OWO as a surgical model for pharmacodynamic studies, with assessment of the following parameters:

* Injecting the desired volume of rhBMP-2/CPM within the defect

* Conducting longitudinal radiographic absorptiometry of the tibial defect in the presence of rhBMP-2/CPM.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-11
• Study Completion: 2005-03
• Study First Submitted: 2005-10-19
• Study First Submitted QC: 2005-10-19
• Study First Posted: 2005-10-21
• Status Verified: 2006-10
• Last Update Submitted: 2006-10-05
• Last Update Posted: 2006-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

• Male or female subjects 45 to 70 years of age
• Within 96 hours prior to dosing, the subject underwent a successful open wedge tibial osteotomy to correct medial compartment OA of the knee.
• Female subjects of childbearing potential must have a negative pregnancy test (hospital acceptable test), upon hospitalization for OWO and agree to use medically approved contraception for the duration of the study.

Other inclusion applies.

Exclusion Criteria

• Subjects with pre-existing conditions of the knee or tibia that would confound an interpretation of results.
• Subjects for whom surgery in the opposite knee is planned during the 6 months of follow-up.
• Subjects with a history of malignancy or radiotherapy or chemotherapy for malignancy within the past 5 years, except subjects with a history of basal skin carcinoma.

Other exclusion applies.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Feasibility of injecting rhBMP-2/CPM using high tibial osteotomy as a surgical model for pharmacodynamic studies
Feasibility measures include
Injection of desired volume of rhBMP-2/CPM within the osteotomy defect
Ability to perform longitudinal radiographic absorptiometry of the defect in the presence of rhBMP-2/CPM.

Secondary Outcome Measures

Name	Time	Method
Safety of administering different volumes of rhBMP-2/CPM in high tibial osteotomy defects. Safety assessed by evaluation of adverse events reported during the duration of the trial.