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| ID | Type | Description | Link |
|---|---|---|---|
| B1921004 |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | 1.0 mg/mL rhBMP-2/CPM + surgical fixation |
|
| B | Experimental | 2.0 mg/mL rhBMP-2/CPM + surgical fixation |
|
| C | Other | Control: Surgical fixation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rhBMP-2/CPM | Drug | one time injection of 3-5 mL test article at time of internal fracture fixation |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | upon completion 6 months of follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| To establish a satisfactory method of administering rhBMP-2/CPM to implement in a phase 3 efficacy trial in this clinical indication. | 6 months follow-up | |
| To estimate the success and failure rates associated with key fracture outcomes. | 6 months follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Aurora | Colorado | 80012 | United States | ||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| rhBMP-2/CPM |
| Drug |
one time injection of 3-5 mL test article at time of internal fracture fixation |
|
| surgical intervention alone | Other | surgical internal fixation of fracture defines the standard of care group |
|
| New Haven |
| Connecticut |
| 06520 |
| United States |
| Pfizer Investigational Site | Clearwater | Florida | 33756 | United States |
| Pfizer Investigational Site | Pinellas Park | Florida | 33703 | United States |
| Pfizer Investigational Site | Decatur | Georgia | 30033 | United States |
| Pfizer Investigational Site | New Brunswick | New Jersey | 08903 | United States |
| Pfizer Investigational Site | Brooklyn | New York | 11220 | United States |
| Pfizer Investigational Site | Elmhurst | New York | 11373 | United States |
| Pfizer Investigational Site | Liverpool | New South Wales | 2170 | Australia |
| Pfizer Investigational Site | Herston | Queensland | 4029 | Australia |
| Pfizer Investigational Site | Adelaide | South Australia | 5000 | Australia |
| Pfizer Investigational Site | Melbourne | Victoria | 3004 | Australia |
| Pfizer Investigational Site | Parkville | Victoria | 3050 | Australia |
| Pfizer Investigational Site | Ajax | Ontario | L157J5 | Canada |
| Pfizer Investigational Site | Chatham | Ontario | N7M 5L9 | Canada |
| Pfizer Investigational Site | Scarborough Village | Ontario | M1E 4B9 | Canada |
| Pfizer Investigational Site | Montreal | Quebec | H4J 1C5 | Canada |
| Pfizer Investigational Site | Oulu | 9002 | Finland |
| Pfizer Investigational Site | Turku | 20520 | Finland |
| Pfizer Investigational Site | Créteil | 94010 | France |
| Pfizer Investigational Site | Marseille | 13009 | France |
| Pfizer Investigational Site | Berlin | 13353 | Germany |
| Pfizer Investigational Site | Münster | 48149 | Germany |
| Pfizer Investigational Site | Budapest | H-1081 | Hungary |
| Pfizer Investigational Site | Debrecen | H-4043 | Hungary |
| Pfizer Investigational Site | Bergen | NO-5009 | Norway |
| Pfizer Investigational Site | Oslo | NO-0407 | Norway |
| Pfizer Investigational Site | Link?ping | SE-581 85 | Sweden |
| Pfizer Investigational Site | Edinburgh | EH16 4SA | United Kingdom |
| Pfizer Investigational Site | Norwich | NR4 7UY | United Kingdom |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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