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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | 1.0 mg/mL rhBMP-2/CPM + SOC |
|
| B | Experimental | 2.0 mg/mL rhBMP-2/CPM + SOC |
|
| C | Active Comparator | Buffer/CPM + SOC |
|
| D | Other | Standard of Care Alone (SOC) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rhBMP-2/CPM | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary efficacy variable in this study is radiographic union. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Wyeth is now a wholly owned subsidiary of Pfizer | Study Director |
| Trial Manager | For Brazil, xavierl@wyeth.com | Principal Investigator |
| Trial Manager | For Mexico, gomezzlj@wyeth.com | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Little Rock | Arkansas | 72205 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35727196 | Derived | 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. |
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| Aurora |
| Colorado |
| 80012 |
| United States |
| Denver | Colorado | 80204 | United States |
| Clearwater | Florida | 33756 | United States |
| St. Petersburg | Florida | 33781 | United States |
| Brooklyn | New York | 11220 | United States |
| Monroe | North Carolina | 28112 | United States |
| Toledo | Ohio | 43606 | United States |
| State College | Pennsylvania | 16801 | United States |
| Herston | Queensland | 4029 | Australia |
| Adelaide | South Australia | 5000 | Australia |
| Melbourne | Victoria | 3004 | Australia |
| São Paulo | São Paulo | 04020-060 | Brazil |
| São Paulo | São Paulo | 08270-070 | Brazil |
| Vancouver | British Columbia | V6Z 1Y6 | Canada |
| Ajax | Ontario | L157J5 | Canada |
| Chatham | Ontario | N7M 5L9 | Canada |
| Oshawa | Ontario | L1G 2B9 | Canada |
| Scarborough Village | Ontario | M1E 4B9 | Canada |
| Windsor | Ontario | N9A 1E1 | Canada |
| Montreal | Quebec | H4J 1C5 | Canada |
| Charlottetown | C1A8T5 | Canada |
| Oulu | 9002 | Finland |
| Turku | 20520 | Finland |
| Angers | 49100 | France |
| Créteil | 94010 | France |
| Berlin | 13353 | Germany |
| Münster | 48149 | Germany |
| Chihuahua City | Chihuahua | 31020 | Mexico |
| Guadalajara | Jalisco | 44280 | Mexico |
| Monterrey | Nuevo León | 64460 | Mexico |
| D.f. | 11250 | Mexico |
| Oslo | NO-0407 | Norway |
| Bucharest | 14461 | Romania |
| Bucharest | 21659 | Romania |
| Bucharest | 50098 | Romania |
| Linköping | SE-581 85 | Sweden |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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