Ignite Creation Date:
2025-12-25 @ 12:02 AM
Ignite Modification Date:
2025-12-25 @ 9:59 PM
Study NCT ID:
NCT06270758
Status:
RECRUITING
Last Update Posted:
2025-02-17
First Post:
2024-02-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Validation of BBCT-hip
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010024', 'term': 'Osteoporosis'}, {'id': 'D006620', 'term': 'Hip Fractures'}, {'id': 'D058866', 'term': 'Osteoporotic Fractures'}], 'ancestors': [{'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'}, {'id': 'D005264', 'term': 'Femoral Fractures'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D025981', 'term': 'Hip Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2030-11-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-14', 'studyFirstSubmitDate': '2024-02-14', 'studyFirstSubmitQcDate': '2024-02-14', 'lastUpdatePostDateStruct': {'date': '2025-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-11-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Femoral fracture event', 'timeFrame': '5 years'}, {'measure': 'BBCT-hip risk prediction', 'timeFrame': '5 years'}], 'secondaryOutcomes': [{'measure': 'T-score', 'timeFrame': '5 years', 'description': 'gold standard parameter for osteoporosis diagnosis'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hip fracture', 'fracture prediction', 'finite element', 'in silico', 'osteoporotic fracture'], 'conditions': ['Osteoporosis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://link.springer.com/article/10.1007/s10439-022-02924-1', 'label': 'Publication about BBCT-hip methodology'}]}, 'descriptionModule': {'briefSummary': 'The clinical study is aimed at assessing the accuracy of the in silico methodology BBCT-hip. BBCT-hip takes as inputs the subject-specific height and weight, and the CT scan of his femur to predict the risk of fracture for the femur upon falling. In the study, 150 subjects who suffered from a fracture will be enrolled, in addition to 150 control subjects. CT scans will be carried out for both groups (no later than 3 months for the fracture group) and BBCT-hip run,in order that the risk of fracture will be obtained. First, a transversal study will be performed, where the stratification accuracy of BBCT-hip will be assessed in terms of the ability of the predicted risk of fracture to separate fracture and control subjects. Furthermore, the control subjets will be followed up to assess BBCT-hip predictive accuracy through a longitudinal study.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '65 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Resident in Emilia Romagna, Italy', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* caucasic post-menopausal women resident in Emilia-Romagna\n* menopause (\\>= 45 years)\n\nExclusion Criteria:\n\n* tumours\n* not free living\n* Chronic diseases with severe organ failure / endocrine diseases of parathyroid, thyroid, adrenal gland / intestinal malabsorption, osteomalacia / Paget bone / rheumatoid arthritis. Neurodegenerative diseases\n* Long-term continuous therapy (\\>3 months) with corticosteroids and proton pump inhibitors or aromatase inhibitors\n* Previous femur fractures\n* Presence of hip/knee prosthesis\n\nonly for the fracturegroup:\n\n* presence of fixation devices after the fracture\n* femur fracture due to high energy trauma'}, 'identificationModule': {'nctId': 'NCT06270758', 'acronym': 'ValidaBBCT-hip', 'briefTitle': 'Clinical Validation of BBCT-hip', 'organization': {'class': 'OTHER', 'fullName': 'Istituto Ortopedico Rizzoli'}, 'officialTitle': 'Clinical Validation of BBCT-hip Methodology for Femur Fracture Risk Prediction', 'orgStudyIdInfo': {'id': '453/2023/Sper/IOR'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Fractured subjects', 'description': 'Post-menopausal women who have been hospitalised because of a femur fracture.', 'interventionNames': ['Diagnostic Test: CT scan at the femur']}, {'label': 'Control subjetcs', 'description': 'Post-menopausal women without history of fracture', 'interventionNames': ['Diagnostic Test: CT scan at the femur']}], 'interventions': [{'name': 'CT scan at the femur', 'type': 'DIAGNOSTIC_TEST', 'description': 'Additional CT scan which is not part of the standard clinical path', 'armGroupLabels': ['Control subjetcs', 'Fractured subjects']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40136', 'city': 'Bologna', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Alessandra Aldieri, PhD', 'role': 'CONTACT', 'email': 'alessandra.aldieri@ior.it', 'phone': '+390516366565'}, {'name': 'Fabio Baruffaldi', 'role': 'CONTACT', 'email': 'fabio.baruffaldi@ior.it', 'phone': '+390516366850'}], 'facility': 'Rizzoli Orthopaedic Institute', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'zip': '40136', 'city': 'Bologna', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Alessandra Aldieri, PhD', 'role': 'CONTACT', 'email': 'alessandra.aldieri@polito.ior.ir', 'phone': '+39 051 636 6565'}, {'name': 'Fabio Baruffaldi', 'role': 'CONTACT', 'email': 'fabio.baruffaldi@ior.it', 'phone': '+ 39 051 6366850'}], 'facility': 'Rizzoli Orthopaedic Institute', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istituto Ortopedico Rizzoli', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}