FracturesPhase 2NCT00384852
A Study of rhBMP-2/CPM in Closed Fractures of the Humerus
A Phase 2 study testing rhBMP-2/CPM in people with Fractures, run by Wyeth is now a wholly owned subsidiary of Pfizer at 37 sites in 11 countries.
Trial summary
The primary objective of this study is to assess whether fracture union is accelerated in subjects with humeral fractures (proximal,diaphyseal) treated with conservative therapy (standard of care) and a single dose of rhBMP-2/CPM compared to subjects who receive standard of care alone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fractures
- What is being tested?
- rhBMP-2/CPM
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 139 participants
- Where
- 37 sitesin 11 countries
- Study dates
- Jan 2007to Feb 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Skeletally mature subjects age 18 years or older.
- Subjects with either a closed proximal humeral fracture or a diaphyseal humeral fracture.
- Treatment plan that includes only conservative (nonoperative) therapy within 48 hours following injury.
Who cannot join
- Shoulder dislocation at the time of injury.
- Planned procedure(s) at that would stimulate fracture union at the time of application of the initial immobilization device.
- Fractures located in the distal third of humerus.
Trial locations and contacts
37 sites in 11 countries.
37 sites in 11 countries
United States9 sites
Study site
Aurora, Colorado, 80012
Study site
Brooklyn, New York, 11220
Study site
Clearwater, Florida, 33756
Study site
Denver, Colorado, 80204
Study site
Little Rock, Arkansas, 72205
Study site
Monroe, North Carolina, 28112
Study site
St. Petersburg, Florida, 33781
Study site
State College, Pennsylvania, 16801
Study site
Toledo, Ohio, 43606
Canada8 sites
Study site
Ajax, Ontario, L157J5
Study site
Charlottetown, C1A8T5
Study site
Chatham, Ontario, N7M 5L9
Study site
Montreal, Quebec, H4J 1C5
Study site
Oshawa, Ontario, L1G 2B9
Study site
Scarborough Village, Ontario, M1E 4B9
Study site
Vancouver, British Columbia, V6Z 1Y6
Study site
Windsor, Ontario, N9A 1E1
Mexico4 sites
Study site
Chihuahua City, Chihuahua, 31020
Study site
D.f., 11250
Study site
Guadalajara, Jalisco, 44280
Study site
Monterrey, Nuevo León, 64460
Australia3 sites
Study site
Adelaide, South Australia, 5000
Study site
Herston, Queensland, 4029
Study site
Melbourne, Victoria, 3004
Romania3 sites
Study site
Bucharest, 14461
Study site
Bucharest, 21659
Study site
Bucharest, 50098
Brazil2 sites
Study site
São Paulo, São Paulo, 04020-060
Study site
São Paulo, São Paulo, 08270-070
About this study
Official title: A Phase 2, Multicenter, Double-Blind, Randomized, Stratified, Controlled, Efficacy, Safety and Feasibility Study of Recombinant Human Bone Morphogenetic Protein-2 (rhBMP-2)/Calcium Phosphate Matrix (CPM) as an Adjuvant Therapy in Closed Fractures of the Humerus
The primary objective of this study is to assess whether fracture union is accelerated in subjects with humeral fractures (proximal,diaphyseal) treated with conservative therapy (standard of care) and a single dose of rhBMP-2/CPM compared to subjects who receive standard of care alone.
- Conditions
- Fractures
- Being tested
- rhBMP-2/CPM
- Keywords
- Fracture, Humerus
- 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
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | 1.0 mg/mL rhBMP-2/CPM + SOC Receives: Drug: rhBMP-2/CPM |
| B | Experimental | 2.0 mg/mL rhBMP-2/CPM + SOC Receives: Drug: rhBMP-2/CPM |
| C | Active comparator | Buffer/CPM + SOC Receives: Drug: rhBMP-2/CPM |
| D | Other | Standard of Care Alone (SOC) Receives: Drug: rhBMP-2/CPM |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy variable in this study is radiographic union.
Measured: Fracture union is assessed at 4, 6, 8, 10, 12, 16, 26 and 52 week visits. The goal of acceleration of fracture union will be met if median time to radiographic fracture union is decreased by 4 weeks in an active treatment arm compared to SOC alone.
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 startJan 2007
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 139 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
- Medical Monitor, Study director, Wyeth is now a wholly owned subsidiary of PfizerTrial Manager, Principal investigator, For Brazil, xavierl@wyeth.comTrial Manager, Principal investigator, For Mexico, gomezzlj@wyeth.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00384852
- Sponsor's protocol ID
- 3100N7-212
- Status last verified
- Feb 2013
- First submitted
- 3 Oct 2006
- Last updated
- 28 Feb 2013
- Results posted
- No
Publications
Handoll HH, Elliott J, Thillemann TM, Aluko P, Brorson S. Interventions for treating proximal humeral fractures in adults. Cochrane Database Syst Rev. 2022 Jun 21;6(6):CD000434. doi: 10.1002/14651858.CD000434.pub5.
PubMed 35727196
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, Double-Blind, Randomized, Stratified, Controlled, Efficacy, Safety and Feasibility Study of Recombinant Human Bone Morphogenetic Protein-2 (rhBMP-2)/Calcium Phosphate Matrix (CPM) as an Adjuvant Therapy in Closed Fractures of the Humerus
- ClinicalTrials.gov ID
- NCT00384852
- Acronym / sponsor ID
- 3100N7-212
- Conditions
- Fractures
- Keywords
- Fracture, Humerus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Jan 2007
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 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 whether fracture union is accelerated in subjects with humeral fractures (proximal,diaphyseal) treated with conservative therapy (standard of care) and a single dose of rhBMP-2/CPM compared to subjects who receive standard of care alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: rhBMP-2/CPM1.0 mg/mL rhBMP-2/CPM + SOC |
| B | Experimental | Drug: rhBMP-2/CPM2.0 mg/mL rhBMP-2/CPM + SOC |
| C | Active comparator | Drug: rhBMP-2/CPMBuffer/CPM + SOC |
| D | Other | Drug: rhBMP-2/CPMStandard of Care Alone (SOC) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Skeletally mature subjects age 18 years or older.
- Subjects with either a closed proximal humeral fracture or a diaphyseal humeral fracture.
- Treatment plan that includes only conservative (nonoperative) therapy within 48 hours following injury.
Key exclusion criteria (3 listed)
- Shoulder dislocation at the time of injury.
- Planned procedure(s) at that would stimulate fracture union at the time of application of the initial immobilization device.
- Fractures located in the distal third of humerus.
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 | A, B, C, D |
Primary outcome
The primary efficacy variable in this study is radiographic union.
Time frame: Fracture union is assessed at 4, 6, 8, 10, 12, 16, 26 and 52 week visits. The goal of acceleration of fracture union will be met if median time to radiographic fracture union is decreased by 4 weeks in an active treatment arm compared to SOC alone.
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.
- Derived from this study: PubMed 35727196Handoll HH, Elliott J, Thillemann TM, Aluko P, Brorson S. Interventions for treating proximal humeral fractures in adults. Cochrane Database Syst Rev. 2022 Jun 21;6(6):CD000434. doi: 10.1002/14651858.CD000434.pub5.
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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
Trial Manager principal investigator
For Brazil, xavierl@wyeth.com
Trial Manager principal investigator
For Mexico, gomezzlj@wyeth.com
37 sites in 11 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 in people with Fractures, run by Wyeth is now a wholly owned subsidiary of Pfizer at 37 sites in 11 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 37 sites in United States, Canada, Mexico, Australia, Romania and 6 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 primary efficacy variable in this study is radiographic union. (time frame: Fracture union is assessed at 4, 6, 8, 10, 12, 16, 26 and 52 week visits. The goal of acceleration of fracture union will be met if median time to radiographic fracture union is decreased by 4 weeks in an active treatment arm compared to SOC alone.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00384852, which also lists 1 linked publication.
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.