FracturesPhase 2NCT00384358
Feasibility And Safety Study Of rhBMP-2/CPM For Hip Fractures
A Phase 2 study testing rhBMP-2/CPM and surgical intervention alone in people with Fractures, run by Wyeth is now a wholly owned subsidiary of Pfizer at 30 sites in 10 countries.
Trial summary
The primary objective of this study is to assess the safety of administering rhBMP-2/CPM as an adjuvant to internal fixation in subjects with fractures of the proximal femur. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Fractures
- What is being tested?
- rhBMP-2/CPM and surgical intervention alone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 30 sitesin 10 countries
- Study dates
- Dec 2006to Jun 2010
- Phase
- Phase 2
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 55 or older.
- Acute fracture of the proximal femur: displaced femoral neck fracture or unstable intertrochanteric femur fracture.
- Anatomic reduction (open or closed) and internal fixation within 48 hours following injury using any one of the following fixation constructs: 1) multiple parallel interfragmentary screws; 2) sliding hip screw and side plate fixation; or 3) cephalomedullary nail.
Who cannot join
- Concurrent fractures of the ipsilateral or contralateral lower extremity that would impede performance on functional assessments.
- Previous arthroplasty of contralateral (unaffected) hip.
- Planned procedure(s) to stimulate fracture healing after internal fixation of the fractured hip.
Trial locations and contacts
30 sites in 10 countries.
30 sites in 10 countries
United States8 sites
Pfizer Investigational Site
Aurora, Colorado, 80012
Pfizer Investigational Site
Brooklyn, New York, 11220
Pfizer Investigational Site
Clearwater, Florida, 33756
Pfizer Investigational Site
Decatur, Georgia, 30033
Pfizer Investigational Site
Elmhurst, New York, 11373
Pfizer Investigational Site
New Brunswick, New Jersey, 08903
Pfizer Investigational Site
New Haven, Connecticut, 06520
Pfizer Investigational Site
Pinellas Park, Florida, 33703
Australia5 sites
Pfizer Investigational Site
Adelaide, South Australia, 5000
Pfizer Investigational Site
Herston, Queensland, 4029
Pfizer Investigational Site
Liverpool, New South Wales, 2170
Pfizer Investigational Site
Melbourne, Victoria, 3004
Pfizer Investigational Site
Parkville, Victoria, 3050
Canada4 sites
Pfizer Investigational Site
Ajax, Ontario, L157J5
Pfizer Investigational Site
Chatham, Ontario, N7M 5L9
Pfizer Investigational Site
Montreal, Quebec, H4J 1C5
Pfizer Investigational Site
Scarborough Village, Ontario, M1E 4B9
Finland2 sites
Pfizer Investigational Site
Oulu, 9002
Pfizer Investigational Site
Turku, 20520
France2 sites
Pfizer Investigational Site
Créteil, 94010
Pfizer Investigational Site
Marseille, 13009
Germany2 sites
Pfizer Investigational Site
Berlin, 13353
Pfizer Investigational Site
Münster, 48149
Hungary2 sites
Pfizer Investigational Site
Budapest, H-1081
Pfizer Investigational Site
Debrecen, H-4043
Norway2 sites
Pfizer Investigational Site
Bergen, NO-5009
Pfizer Investigational Site
Oslo, NO-0407
United Kingdom2 sites
Pfizer Investigational Site
Edinburgh, EH16 4SA
Pfizer Investigational Site
Norwich, NR4 7UY
About this study
Official title: A Phase 2, Multicenter, Single-Blind, Randomized, Stratified, Standard-Of-Care Controlled, Feasibility And Safety Study Of rhBMP-2/CPM As An Adjuvant Therapy For Fractures Of The Proximal Femur
The primary objective of this study is to assess the safety of administering rhBMP-2/CPM as an adjuvant to internal fixation in subjects with fractures of the proximal femur.
- Conditions
- Fractures
- Being tested
- rhBMP-2/CPM, surgical intervention alone
- Keywords
- Fractures
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rhBMP-2/CPMDrug
one time injection of 3-5 mL test article at time of internal fracture fixation
rhBMP-2/CPMDrug
one time injection of 3-5 mL test article at time of internal fracture fixation
surgical intervention aloneOther
surgical internal fixation of fracture defines the standard of care group
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | 1.0 mg/mL rhBMP-2/CPM + surgical fixation Receives: Drug: rhBMP-2/CPM |
| B | Experimental | 2.0 mg/mL rhBMP-2/CPM + surgical fixation Receives: Drug: rhBMP-2/CPM |
| C | Other | Control: Surgical fixation Receives: Other: surgical intervention alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
The safety outcome is the incidence of secondary fracture displacement among subjects treated with rhBMP-2/CPM compared to those receiving standard surgical treatment (internal fixation) alone.
Measured: upon completion 6 months of follow-up
Secondary outcomes (2)
To establish a satisfactory method of administering rhBMP-2/CPM to implement in a phase 3 efficacy trial in this clinical indication.
Measured: 6 months follow-up
To estimate the success and failure rates associated with key fracture outcomes.
Measured: 6 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2006 (estimated)
- Study startDec 2006
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FracturesStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00384358
- Sponsor's protocol ID
- 3100N7-211
- Other IDs
- B1921004
- Status last verified
- Feb 2013
- First submitted
- 3 Oct 2006
- Last updated
- 28 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter, Single-Blind, Randomized, Stratified, Standard-Of-Care Controlled, Feasibility And Safety Study Of rhBMP-2/CPM As An Adjuvant Therapy For Fractures Of The Proximal Femur
- ClinicalTrials.gov ID
- NCT00384358
- Acronym / sponsor ID
- 3100N7-211
- Conditions
- Fractures
- Keywords
- Fractures
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 6 Oct 2006 (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.
The primary objective of this study is to assess the safety of administering rhBMP-2/CPM as an adjuvant to internal fixation in subjects with fractures of the proximal femur.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: rhBMP-2/CPM1.0 mg/mL rhBMP-2/CPM + surgical fixation |
| B | Experimental | Drug: rhBMP-2/CPM2.0 mg/mL rhBMP-2/CPM + surgical fixation |
| C | Other | Other: surgical intervention aloneControl: Surgical fixation |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 55 or older.
- Acute fracture of the proximal femur: displaced femoral neck fracture or unstable intertrochanteric femur fracture.
- Anatomic reduction (open or closed) and internal fixation within 48 hours following injury using any one of the following fixation constructs: 1) multiple parallel interfragmentary screws; 2) sliding hip screw and side plate fixation; or 3) cephalomedullary nail.
Key exclusion criteria (3 listed)
- Concurrent fractures of the ipsilateral or contralateral lower extremity that would impede performance on functional assessments.
- Previous arthroplasty of contralateral (unaffected) hip.
- Planned procedure(s) to stimulate fracture healing after internal fixation of the fractured hip.
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/CPMone time injection of 3-5 mL test article at time of internal fracture fixation | Drug | A |
| rhBMP-2/CPMone time injection of 3-5 mL test article at time of internal fracture fixation | Drug | B |
| surgical intervention alonesurgical internal fixation of fracture defines the standard of care group | Other | C |
Primary outcome
The safety outcome is the incidence of secondary fracture displacement among subjects treated with rhBMP-2/CPM compared to those receiving standard surgical treatment (internal fixation) alone.
Time frame: upon completion 6 months of follow-up
2 secondary outcomes
To establish a satisfactory method of administering rhBMP-2/CPM to implement in a phase 3 efficacy trial in this clinical indication.
Time frame: 6 months follow-up
To estimate the success and failure rates associated with key fracture outcomes.
Time frame: 6 months follow-up
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 28 Feb 2013.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
30 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing rhBMP-2/CPM and surgical intervention alone in people with Fractures, run by Wyeth is now a wholly owned subsidiary of Pfizer at 30 sites in 10 countries.
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 3 inclusion and 3 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 28 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in United States, Australia, Canada, Finland, France and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The safety outcome is the incidence of secondary fracture displacement among subjects treated with rhBMP-2/CPM compared to those receiving standard surgical treatment (internal fixation) alone. (time frame: upon completion 6 months of follow-up). 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 28 Feb 2013.