Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:57 AM
Study NCT ID:
NCT05721118
Status:
UNKNOWN
Last Update Posted:
2023-02-28
First Post:
2023-01-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Diagnostic Performances of Mandibular CBCT in Osteoporosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010024', 'term': 'Osteoporosis'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-03-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2023-03-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-27', 'studyFirstSubmitDate': '2023-01-31', 'studyFirstSubmitQcDate': '2023-01-31', 'lastUpdatePostDateStruct': {'date': '2023-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of diagnostic performances of CBCT multivariate explicative model of osteoporosis regarding DXA T-Score Gold-Standard (-2,5DS).', 'timeFrame': 'Day1 of retrospective CBCT/DXA acquisition analysis', 'description': 'Sensitivity (Se), Specificity (Sp), Negative Predictive Value (NPV), Positive Predictive Value (PPV), AUC.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Osteoporosis']}, 'referencesModule': {'references': [{'pmid': '37000207', 'type': 'DERIVED', 'citation': 'Legrand A, Autrusseau F, Bandiaky ON, Idiri K, Le Goff B, Amador G, Volteau C, Maugars Y, Soueidan A. Promising diagnostic performance of CBCT-based TOMOSTEOp algorithm in osteoporosis: toward a complementary populational screening tool managed by dentists? Osteoporos Int. 2023 Jun;34(6):1137-1138. doi: 10.1007/s00198-023-06724-8. Epub 2023 Mar 31. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'In the last decade, there has been a shift towards Cone-Beam Computed Tomography (CBCT - regarding its low-dose radiation profile) in Dentistry/Implantology fields because it presents a more conclusive insight in the bone micro-architecture and cortical/trabecular bone structures assessment due to 3D acquisition higher resolution. Despite convergent and interesting preliminary results, most CBCT studies failed in highlighting a potential new osteoporosis diagnostic tool. TOMOSTEOp study aims to explore inter-relation between CBCT parameters and DXA Gold-Standard parameters in order to build resolutive explicative model of bone mineral density and test CBCT diagnostic performances.', 'detailedDescription': 'In the last decade, there has been a shift towards Cone-Beam Computed Tomography (CBCT - regarding its low-dose radiation profile) in Dentistry/Implantology fields because it presents a more conclusive insight in the bone micro-architecture and cortical/trabecular bone structures assessment due to 3D acquisition higher resolution. Despite convergent and interesting preliminary results, most CBCT studies failed in highlighting a potential new osteoporosis diagnostic tool. TOMOSTEO aims to explore inter-relation between CBCT parameters and DXA Gold-Standard parameters in order to build resolutive explicative model of bone mineral density and test CBCT diagnostic performances.\n\nTOMOSTEOp study will analyze CBCT and DXA acquisitions of \\>65 years old post-menopausal women who performed contemporaneously (ie. maximum 3months delay) these 2 exams. Radiomorphometric (I/S/CTMI/CTI(S)/CTI(I)), Gray Values (cortical and trabecular) and Fractal Dimension Indexes will be measured on the whole mandibular arch, as well as cortical/trabecular thicknesses. Correlations and odds-ratio will be calculated regarding DXA parameters and T-scores (-2,5DS). Differences between osteopenic, osteoporotic and healthy women will be explored.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '\\>65 years old post-menopausal women who performed contemporaneously (ie. maximum 3months delay)', 'genderDescription': 'Post-menauposal women', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\> 65 years old post-menauposal women\n* Contemporanean (ie. 3months) CBCT and DXA exams performed in Nantes University Hospital.\n\nExclusion Criteria:\n\n* \\< 65 years old post-menauposal women\n* CBCT and DXA exams interval superior to 3months.'}, 'identificationModule': {'nctId': 'NCT05721118', 'acronym': 'TOMOSTEOp', 'briefTitle': 'Diagnostic Performances of Mandibular CBCT in Osteoporosis', 'organization': {'class': 'OTHER', 'fullName': 'Nantes University Hospital'}, 'officialTitle': 'Diagnostic Performances of Mandibular CBCT Versus DXA Gold-Standard in Bone Mineral Density Assessment and Osteoporosis Diagnosis.', 'orgStudyIdInfo': {'id': 'TOMOSTEOp_AL_190123'}}, 'armsInterventionsModule': {'interventions': [{'name': 'CBCT and DXA exams performed in current practice in Nantes University Hospital', 'type': 'DIAGNOSTIC_TEST', 'description': '40 patients will be enrolled in order to study DXA/CBCT acquisitions of 16 osteoporotic women vs 34 osteopenic/healthy women (Estimated osteoporotic rate = 20%)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Anonymized data. No sharing.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nantes University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}