Ignite Creation Date:
2025-12-24 @ 1:20 PM
Ignite Modification Date:
2026-06-13 @ 7:49 PM
Study NCT ID:
NCT04110795
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-06-01
First Post:
2019-09-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Personalizing Osteoporosis Care: Clinical & Genetic Risk Factors for AFFs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'whole blood samples serum samples fingernail samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-06-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-30', 'studyFirstSubmitDate': '2019-09-25', 'studyFirstSubmitQcDate': '2019-09-30', 'lastUpdatePostDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Associations between AFF and clinical Risk Factor', 'timeFrame': 'baseline', 'description': 'Associations between AFFs and clinical risk factors'}, {'measure': 'Associations between AFF and common genetic variants', 'timeFrame': 'baseline', 'description': 'Associations of common genetic variants among patients with AFFs'}, {'measure': 'Validation of top genetic variants', 'timeFrame': 'baseline', 'description': 'To validate the top few genetic variants identified in the above case-control study in a separate cohort of 100 cases and 100 controls.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atypical Femur Fracture']}, 'descriptionModule': {'briefSummary': 'The overall objective of this project is to identify clinical and genetic risk factors for Atypical Femur Fractures (AFFs) in Anti-resorptive therapy (ART) users by conducting a case control study of 330 cases of AFFs and 660 controls without AFFs matched for age, sex, race and duration of ART.', 'detailedDescription': 'Antiresorptive therapy (ART) drugs are effective osteoporosis treatment and help decrease osteoporosis-related fractures. However, their long-term use has been associated with rare but serious atypical femur fractures (AFFs). Fear of these side effects has caused a substantial decline in the use of these effective drugs and rising fracture rates. The investigators propose to compare 330 cases of people with AFFs to 660 matched controls to explore similarities and differences in (1) clinical findings, such as type of ART and length of use, prior fracture, bone density, femur geometry, etc., and (2) genetic variants, and then (3) to validate the top few genetic variants to see if they are indeed present in an additional group of 100 AFF patients and not present in 100 control subjects. This study will determine clinical and genetic risk factors for these debilitating atypical fractures such that at-risk patients in the future can be treated differently to avoid them.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Community based population in Ontario and British Columbia Canada', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Cases: Have experienced a confirmed, documented Atypical femur fracture\n* Controls: currently on anti-resorptive therapy, matches AFF case by age, race and length of ART use\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT04110795', 'briefTitle': 'Personalizing Osteoporosis Care: Clinical & Genetic Risk Factors for AFFs', 'organization': {'class': 'OTHER', 'fullName': 'University Health Network, Toronto'}, 'officialTitle': 'Personalizing Osteoporosis Care: Clinical & Genetic Risk Factors for Atypical Femur Fractures', 'orgStudyIdInfo': {'id': '18-6171'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cases', 'description': 'Atypical Femur fracture cases', 'interventionNames': ['Other: No Intervention']}, {'label': 'Control', 'description': 'matched to AFF cases by race, age, length of ART use', 'interventionNames': ['Other: No Intervention']}], 'interventions': [{'name': 'No Intervention', 'type': 'OTHER', 'description': 'No Intervention', 'armGroupLabels': ['Cases', 'Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'L8N 1Y2', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Adachi Medical Centre', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'L6M 1M1', 'city': 'Oakville', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Bone Research & Education Centre', 'geoPoint': {'lat': 43.45011, 'lon': -79.68292}}, {'zip': 'M5G 2C4', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'University Health Network, TGH', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Angela M Cheung, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Health Network, Toronto'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Health Network, Toronto', 'class': 'OTHER'}, 'collaborators': [{'name': 'Canadian Institutes of Health Research (CIHR)', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}