OsteoarthritisPhase 1NCT00243295
Study Evaluating rhMBP-2/CPM in Open Wedge Osteotomies
A Phase 1 study testing rhBMP-2/CPM in people with Osteoarthritis, run by Wyeth is now a wholly owned subsidiary of Pfizer.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 70 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- rhBMP-2/CPM
- How many people
- 6 participants
- Where
- No sites listed yet
- Study dates
- Nov 2003to Mar 2005
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: A Pilot Study to Validate the Feasibility of Injecting and Monitoring Recombinant Human Bone Morphogenetic Protein-2/Calcium Phosphate Matrix (rhBMP-2/CPM) in Subjects With Open Wedge Osteotomies
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.
- Conditions
- Osteoarthritis
- Being tested
- rhBMP-2/CPM
- Keywords
- osteoarthritis, deformity of knee
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rhBMP-2/CPMDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2005 (estimated)
- Study startNov 2003
- Study completionMar 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Early clinical test
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Monitor, Study director, Wyeth is now a wholly owned subsidiary of Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00243295
- Sponsor's protocol ID
- 3100N7-110
- Status last verified
- Oct 2006
- First submitted
- 19 Oct 2005
- Last updated
- 6 Oct 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Validate the Feasibility of Injecting and Monitoring Recombinant Human Bone Morphogenetic Protein-2/Calcium Phosphate Matrix (rhBMP-2/CPM) in Subjects With Open Wedge Osteotomies
- ClinicalTrials.gov ID
- NCT00243295
- Acronym / sponsor ID
- 3100N7-110
- Conditions
- Osteoarthritis
- Keywords
- osteoarthritis, deformity of knee
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Nov 2003
- Study completion
- Mar 2005
- First posted
- 21 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Early clinical test
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rhBMP-2/CPM | Drug | – |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Monitor study director
Wyeth is now a wholly owned subsidiary of Pfizer
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing rhBMP-2/CPM in people with Osteoarthritis, run by Wyeth is now a wholly owned subsidiary of Pfizer.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2006. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of injecting rhBMP-2/CPM using high tibial osteotomy as a surgical model for pharmacodynamic studies. The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2006; AzTrials last refreshed its copy on 30 Oct 2026.