Ignite Creation Date:
2025-12-24 @ 5:21 PM
Ignite Modification Date:
2026-02-25 @ 7:22 PM
Study NCT ID:
NCT02150850
Status:
RECRUITING
Last Update Posted:
2024-11-20
First Post:
2014-05-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quebec Registry for Atypical Femur Fractures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005264', 'term': 'Femoral Fractures'}, {'id': 'D006620', 'term': 'Hip Fractures'}, {'id': 'D058866', 'term': 'Osteoporotic Fractures'}, {'id': 'D005598', 'term': 'Fractures, Spontaneous'}, {'id': 'D015775', 'term': 'Fractures, Stress'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D010024', 'term': 'Osteoporosis'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D025981', 'term': 'Hip Injuries'}, {'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'AFF patients only will be asked to deposit 2 ml of saliva into a collection tube using a standardized protocol. Individuals unable to produce 2ml of saliva will be asked to perform at least two buccal swabs.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'targetDuration': '3 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-19', 'studyFirstSubmitDate': '2014-05-20', 'studyFirstSubmitQcDate': '2014-05-27', 'lastUpdatePostDateStruct': {'date': '2024-11-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-05-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change from baseline in functional impairment', 'timeFrame': '6- 12- 24- 36- months post fracture', 'description': 'Measured using the Lower Extremity Functional Scale (LEFS).'}, {'measure': 'Change in global function status', 'timeFrame': '6- 12- 24- 36- months post fracture', 'description': 'Measured using The Reintegration to Normal Living Index (RNLI).'}], 'primaryOutcomes': [{'measure': 'Predictors associated with AFFs', 'timeFrame': 'Baseline', 'description': 'Measured as the frequency of possible risk factors including demographic and clinical characteristics.'}], 'secondaryOutcomes': [{'measure': 'Differences in lower limb geometric parameters between cases and controls', 'timeFrame': 'Baseline', 'description': 'Measured from 3D images reconstructed using scans procured using the EOS® low irradiation 2D-3D X-Ray scanner.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Femoral Fractures', 'Subtrochanteric Fractures', 'Osteoporotic Fractures', 'Fractures, Spontaneous', 'Stress Fractures', 'Bone Fractures', 'Hip Fractures', 'Osteoporosis'], 'conditions': ['Atypical Femur Fracture']}, 'descriptionModule': {'briefSummary': 'Bisphosphonates are recommended as first-line agents to reduce fracture risk in patients with osteoporosis and have in general an excellent safety profile. However, recent reports have noted that prolonged use of bisphosphonates may be associated with rare but serious adverse effects, namely atypical femur fractures (AFF), an atraumatic subset of subtrochanteric and diaphyseal fractures.\n\nThe overarching aim of this project is to contribute to the characterization of clinical, biomechanical, radiological and genetic predictors of AFF, associated or not with bisphosphonate and-or denosumab therapy. AFF arise on the lateral (external) aspect of the subtrochanteric and diaphyseal regions of the femur, regions subjected to high mechanical loads. Because of this unique distribution, the investigators hypothesis is that patients with AFF demonstrate specific geometrical variations of their femur whereby baseline tensile forces applied to the lateral cortex are higher and might favour the appearance of these rare stress fractures. Measurements to investigate these geometric variations with be calculated from 3D images reconstructed using scans procured using the EOS® low irradiation 2D-3D X-Ray scanner.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who have sustained an AFF.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 45 years and older\n* men and women from Quebec who sustain (or have sustained) an AFF (complete or incomplete), as defined by the American Society of Bone and mineral Research (ASBMR) International Task Force on AFFs (Shane E et al J Bone Miner Res 2014;29:1-24)\n\nExclusion Criteria:\n\n* inability to consent\n* disorders of bone metabolism other than osteoporosis\n* active cancer\n* life expectancy less than 12 months.'}, 'identificationModule': {'nctId': 'NCT02150850', 'briefTitle': 'Quebec Registry for Atypical Femur Fractures', 'organization': {'class': 'OTHER', 'fullName': 'McGill University'}, 'officialTitle': 'Quebec Registry for Atypical Femur Fractures', 'orgStudyIdInfo': {'id': 'A00-M23-12A'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Registry', 'description': 'Patients who have who have sustained an AFF that consent to participating in the registry only.'}, {'label': 'Cases', 'description': 'Patients who have sustained an AFF that consent to participating in the registry and undergoing EOS® imaging.'}, {'label': 'Controls', 'description': 'For each case we will identify one age- (± 5 years), sex-, height- (± 6 cm) and cumulative bisphosphonate or denosumab exposure ( ±2 years) matched control who has not sustained an AFF to undergo EOS® imaging.'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H3G 1A4', 'city': 'Montreal', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'facility': 'Montreal General Hospital', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'centralContacts': [{'name': 'Michelle Wall, MSc.', 'role': 'CONTACT', 'email': 'michelle.wall@mail.mcgill.ca', 'phone': '514-934-1934', 'phoneExt': '45742'}], 'overallOfficials': [{'name': 'Suzanne Morin, MD MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'McGill University Health Centre/Research Institute of the McGill University Health Centre'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'McGill University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fonds de la Recherche en Santé du Québec', 'class': 'OTHER_GOV'}, {'name': 'McGill University Health Centre/Research Institute of the McGill University Health Centre', 'class': 'OTHER'}, {'name': 'Canadian Institutes of Health Research (CIHR)', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Dr. Suzanne Morin', 'investigatorAffiliation': 'McGill University'}}}}