Study Evaluating rhMBP-2/CPM in Open Wedge Osteotomies

• Status: Completed
• Trial end date: 2005-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

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

Criteria

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.