Ignite Creation Date:
2025-12-24 @ 4:57 PM
Ignite Modification Date:
2025-12-30 @ 3:52 AM
Study NCT ID:
NCT05303350
Status:
WITHDRAWN
Last Update Posted:
2025-11-20
First Post:
2022-03-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of the Effectiveness of a Web Fracture Liaison Service (e_FLS) to Fracture Liaison Services in France: the evAB Study (evAB)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010024', 'term': 'Osteoporosis'}, {'id': 'D050723', 'term': 'Fractures, Bone'}], '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': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'logistic difficulties', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2024-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2022-03-21', 'studyFirstSubmitQcDate': '2022-03-21', 'lastUpdatePostDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To compare the efficacy of eFLS to conventional FLS to initiate an antiosteoporotic treatment after a recent fracture (<3 months) at one year in patients aged 60 years and more', 'timeFrame': 'one year', 'description': 'Number of patients receiving an antiosteoporotic treatment at one year'}], 'secondaryOutcomes': [{'measure': 'To compare the number of patients with recent fracture (less of 3 months) in the eFLS and conventional FLSs', 'timeFrame': 'one year', 'description': 'Number of patients seen in the FLS'}, {'measure': 'To compare the proportion of patients with incident fracture over one year seen in the eFLS and in conventional FLS', 'timeFrame': 'one year', 'description': 'Incident fracture rate over 1 year'}, {'measure': 'To compare the proportion of patients with deaths over one year in the eFLS and in conventional FLS', 'timeFrame': 'one year', 'description': 'Mortality rate over 1 year'}, {'measure': 'To compare the proportion of patients with bone densitometry performed over one year in the eFLS and in conventional FLS', 'timeFrame': 'one year', 'description': 'Bone densitometry at 1 year'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Osteoporosis', 'Fracture', 'Fracture liaison service', 'Digital medicine'], 'conditions': ['Osteoporosis', 'Fracture']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare web FLS model (e\\_FLS) to conventional FLS in terms of increasing the proportion of patients receiving an antiosteoporotic treatment in the year after a low trauma fracture.', 'detailedDescription': 'Osteoporotic fractures such as hip fractures and severe fractures are associated with increased morbidity and mortality and impose a large financial burden on healthcare systems. Patients with osteoporosis-related fractures are at higher risk of subsequent fractures. Other severe fractures (pelvis, vertebrae, humerus) have similar consequences, pelvis. The risk of refracture after fracture depends on the time: it is 5 times higher in the first 2-3 years, and 2 times higher after. This notion of Imminent Fracture Risk is the basis for the development of post-fracture care pathways called "fracture liaison. The implementation of FLS is the most effective way to reduce the risk of secondary fracture. Despite their success, FLS programs are not an integral part of post-fracture care throughout the France. The investigators believe that the barriers to the implementation of such a pathway are multiple and are largely related to the lack of accessibility for patients to FLS, and to the mobilization of important and unsustainable human resources. Some French public hospitals or institutions are currently building some e\\_FLS models based on an automatic detection of patients with fractures, and a on a cloud-based system where practitioners across the health care sector can communicate and jointly manage osteoporotic patients. The investigators\' hypothesis is that this web FLS (e\\_FLS) is at least as effective as the classical FLS for the secondary fracture prevention.\n\nThe objective of the investigators\' study is to compare web FLS model (e\\_FLS) to conventional FLS in terms of increasing the proportion of patients receiving an antiosteoporotic treatment in the year after a low trauma fracture (evAB project).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients aged \\> 60 years with recent fracture (less of 3 months) included in existing FLS in France', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Men and women aged above 60 years, living in France, with fragility fractures in response to low-energy trauma (e.g., a fall from standing height).\n* The patient or his legal representative does not object to the patient's participation in the research Note: Patients in guardianship or curatorship can be included in this protocol\n\nExclusion Criteria:\n\n* Pathological fractures, high trauma fractures and per prosthetic fractures.\n* Non registration with a social security scheme (holder or beneficiary)."}, 'identificationModule': {'nctId': 'NCT05303350', 'acronym': 'evAB', 'briefTitle': 'Comparison of the Effectiveness of a Web Fracture Liaison Service (e_FLS) to Fracture Liaison Services in France: the evAB Study (evAB)', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Multicentric Study of Comparison of the Effectiveness of a Web Fracture Liaison Service (e_FLS) to Fracture Liaison Services in France: the evAB Study', 'orgStudyIdInfo': {'id': 'APHP211339'}, 'secondaryIdInfos': [{'id': '2022-A00553-40', 'type': 'OTHER', 'domain': 'ID-RCB Number'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'e_FLS', 'description': 'Patients detected by an automated patient detection tool with a web-based platform'}, {'label': 'FLS', 'description': 'Control group / Conventional group : Patients followed in a conventional fracture liaison department'}]}, 'contactsLocationsModule': {'locations': [{'zip': '75014', 'city': 'Paris', 'country': 'France', 'facility': 'Cochin Hospital, Rheumatology Department', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Karine BRIOT, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'APHP'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': 'French Society of Rheumatology', 'class': 'OTHER'}, {'name': 'URC-CIC Paris Descartes Necker Cochin', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}