Ignite Creation Date:
2025-12-25 @ 12:20 AM
Ignite Modification Date:
2025-12-25 @ 10:24 PM
Study NCT ID:
NCT00384358
Status:
COMPLETED
Last Update Posted:
2013-02-28
First Post:
2006-10-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Feasibility And Safety Study Of rhBMP-2/CPM For Hip Fractures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050723', 'term': 'Fractures, Bone'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 108}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'dispFirstSubmitDate': '2013-02-21', 'completionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-21', 'studyFirstSubmitDate': '2006-10-03', 'dispFirstSubmitQcDate': '2013-02-21', 'studyFirstSubmitQcDate': '2006-10-03', 'dispFirstPostDateStruct': {'date': '2013-02-28', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2013-02-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-10-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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.', 'timeFrame': 'upon completion 6 months of follow-up'}], 'secondaryOutcomes': [{'measure': 'To establish a satisfactory method of administering rhBMP-2/CPM to implement in a phase 3 efficacy trial in this clinical indication.', 'timeFrame': '6 months follow-up'}, {'measure': 'To estimate the success and failure rates associated with key fracture outcomes.', 'timeFrame': '6 months follow-up'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Fractures'], 'conditions': ['Fractures']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=3100N7-211&StudyName=Feasibility%20And%20Safety%20Study%20Of%20rhBMP-2/CPM%20For%20Hip%20Fractures', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 55 or older.\n* Acute fracture of the proximal femur: displaced femoral neck fracture or unstable intertrochanteric femur fracture.\n* 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.\n\nExclusion Criteria:\n\n* Concurrent fractures of the ipsilateral or contralateral lower extremity that would impede performance on functional assessments.\n* Previous arthroplasty of contralateral (unaffected) hip.\n* Planned procedure(s) to stimulate fracture healing after internal fixation of the fractured hip.'}, 'identificationModule': {'nctId': 'NCT00384358', 'briefTitle': 'Feasibility And Safety Study Of rhBMP-2/CPM For Hip Fractures', 'organization': {'class': 'INDUSTRY', 'fullName': 'Wyeth is now a wholly owned subsidiary of Pfizer'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '3100N7-211'}, 'secondaryIdInfos': [{'id': 'B1921004'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'description': '1.0 mg/mL rhBMP-2/CPM + surgical fixation', 'interventionNames': ['Drug: rhBMP-2/CPM']}, {'type': 'EXPERIMENTAL', 'label': 'B', 'description': '2.0 mg/mL rhBMP-2/CPM + surgical fixation', 'interventionNames': ['Drug: rhBMP-2/CPM']}, {'type': 'OTHER', 'label': 'C', 'description': 'Control: Surgical fixation', 'interventionNames': ['Other: surgical intervention alone']}], 'interventions': [{'name': 'rhBMP-2/CPM', 'type': 'DRUG', 'description': 'one time injection of 3-5 mL test article at time of internal fracture fixation', 'armGroupLabels': ['A']}, {'name': 'rhBMP-2/CPM', 'type': 'DRUG', 'description': 'one time injection of 3-5 mL test article at time of internal fracture fixation', 'armGroupLabels': ['B']}, {'name': 'surgical intervention alone', 'type': 'OTHER', 'description': 'surgical internal fixation of fracture defines the standard of care group', 'armGroupLabels': ['C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80012', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '06520', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '33756', 'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'zip': '33703', 'city': 'Pinellas Park', 'state': 'Florida', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 27.8428, 'lon': -82.69954}}, {'zip': '30033', 'city': 'Decatur', 'state': 'Georgia', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 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