Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2026-01-04 @ 7:01 PM
Study NCT ID:
NCT01747304
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-19
First Post:
2012-12-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of IVA (SE Femur Scans) to Identify Incomplete AFFs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 285}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-13', 'studyFirstSubmitDate': '2012-12-07', 'studyFirstSubmitQcDate': '2012-12-10', 'lastUpdatePostDateStruct': {'date': '2025-08-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-12-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HD-IVA visualization of incomplete femur fractures', 'timeFrame': '1 day (one time point )', 'description': 'Hologic DXA scanner using the high-definition IVA (HD-IVA) mode on femur bones will be able to visualize incomplete femur fractures at least 90% of the time in patients with known incomplete AFF.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Atypical Femur Fracture', 'DXA'], 'conditions': ['Atypical Femur Fracture']}, 'descriptionModule': {'briefSummary': 'DXA scanners are routinely used to assess bone mineral density (BMD) and fracture risk in osteoporosis patients. They provide detailed bone imaging in a low radiation setting. Hologic manufactures scanners that are able to perform high definition instant vertebral fracture assessment (HD-IVA) used to screen at-risk patients for asymptomatic spine fractures instantly and reliably at the same time they are having their yearly BMD. We wish to investigate whether this same proven technology (HD-IVA scan mode) used on femurs (the scan mode is now called SE Femur scans) can be used to screen for atypical fractures of the femur in patients at risk for these debilitating fractures. In this proof of concept study, we propose to examine whether DXA scanners can provide a sensitive low radiation screening method to identify incomplete AFFs in patients with known incomplete AFFs and in patients at risk.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Osteoporosis/Bone Mineral Density Lab out-patients', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nKnown AFF group\n\n1. A subject must have experienced an incomplete atypical low trauma fracture of the femoral shaft;\n2. Is a patient at the UHN osteoporosis clinic.\n\nComparison Group\n\n1. Must be scheduled for a bone mineral density scan at UHN\n2. Have been on any bisphosphonate for 5 years or longer, and;\n3. Have unexplained symptoms of leg, hip, thigh, or knee pain.\n\nExclusion Criteria:\n\n* There are no exclusions'}, 'identificationModule': {'nctId': 'NCT01747304', 'briefTitle': 'Evaluation of IVA (SE Femur Scans) to Identify Incomplete AFFs', 'organization': {'class': 'OTHER', 'fullName': 'University Health Network, Toronto'}, 'officialTitle': 'Evaluation of Dual Energy X-ray Absorptiometry Scanners in the Identification of Atypical Femur Fractures - A Validation Study', 'orgStudyIdInfo': {'id': '12-0352'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Screening population', 'description': 'Healthy post-menopausal women attending bone mineral density screening clinic with leg/hip/groin pain/discomfort/weakness an has been on anti-resorptive therapy for at least 5 years.', 'interventionNames': ['Device: DXA Se femur scans (previously called IVA femur)']}, {'label': 'Comparator Group', 'description': 'Control group from Toronto CaMOS cohort willing to participate.', 'interventionNames': ['Device: DXA Se femur scans (previously called IVA femur)']}, {'label': 'AFF group', 'description': 'participants in the AFF Cohort study at UHN', 'interventionNames': ['Device: DXA Se femur scans (previously called IVA femur)']}], 'interventions': [{'name': 'DXA Se femur scans (previously called IVA femur)', 'type': 'DEVICE', 'otherNames': ['SF Femur scans'], 'description': 'Single Energy Beam (previously called inter-vertebral assessment) by Dual energy x-ray absorptiometry of affected femur', 'armGroupLabels': ['AFF group', 'Comparator Group', 'Screening population']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5G 2C4', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'University Health Network', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Angela M Cheung, MD, PhD, CCD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Health Network, Toronto'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Health Network, Toronto', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}