NCT00243295

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Nov 2003

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2003

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 19, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 21, 2005

Completed
Last Updated

October 6, 2006

Status Verified

October 1, 2006

First QC Date

October 19, 2005

Last Update Submit

October 5, 2006

Conditions

Osteoarthritis

Keywords

osteoarthritisdeformity of knee

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (1)

  • 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.

Interventions

rhBMP-2/CPMDRUG

Eligibility Criteria

Age45 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Medical Monitor

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
ECT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 19, 2005

First Posted

October 21, 2005

Study Start

November 1, 2003

Study Completion

March 1, 2005

Last Updated

October 6, 2006

Record last verified: 2006-10