Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2026-03-09 @ 10:52 AM
Study NCT ID:
NCT05422833
Status:
COMPLETED
Last Update Posted:
2022-06-21
First Post:
2022-05-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Medical Management of Fibrous Dysplasia of Bone.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005357', 'term': 'Fibrous Dysplasia of Bone'}, {'id': 'D005359', 'term': 'Fibrous Dysplasia, Polyostotic'}, {'id': 'D001847', 'term': 'Bone Diseases'}], 'ancestors': [{'id': 'D010009', 'term': 'Osteochondrodysplasias'}, {'id': 'D001848', 'term': 'Bone Diseases, Developmental'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 528}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1996-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2019-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-16', 'studyFirstSubmitDate': '2022-05-10', 'studyFirstSubmitQcDate': '2022-06-16', 'lastUpdatePostDateStruct': {'date': '2022-06-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'to compare time elapsed between first symptomes or discovery of bone lesions and the diagnosis of FD', 'timeFrame': '1996-2019', 'description': 'The main objective was to compare time elapsed between first symptomes or discovery of bone lesions and the diagnosis of FD, over 2 periods of time: 1996-2006 (before certification) and 2007-2019 (after certification).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Fibrous Dysplasia of Bone', 'McCune Albright Syndrome', 'rare', 'bone disease', 'healthcare organization'], 'conditions': ['Fibrous Dysplasia of Bone', 'McCune Albright Syndrome']}, 'descriptionModule': {'briefSummary': 'The objective of our study was to assess the effectiveness of our reference center since its constitution.\n\nIn a retrospective cohort study, we compared the activity of our center, including the time elapsed between diagnosis and access to the center and the diagnostic delay of patients with fibrous dysplasia between two periods, 1996-2006 (before certification of our center) and 2007-2019 (after certification of our center).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children and adults with FD/MAS who visited at least once in our center', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nWe have included children and adults with FD/MAS who visited at least once in our center (outpatient and hospitalized patients). The diagnosis was established by an expert of the center, based on clinical, biological, imaging and/or histological arguments\n\nExclusion Criteria:\n\nThe absence of detectable bone lesion'}, 'identificationModule': {'nctId': 'NCT05422833', 'acronym': 'Efficience', 'briefTitle': 'Effectiveness of Medical Management of Fibrous Dysplasia of Bone.', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Effectiveness of Medical Management in the Field of Rare Diseases. The Example of Fibrous Dysplasia of Bone.', 'orgStudyIdInfo': {'id': '370'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Before', 'description': 'Children and adults with FD/MAS who visited at least once in our center (outpatient and hospitalized patients).\n\nand with the first visit in the center included between 1996 and 2006 - before certification of our center.', 'interventionNames': ['Other: Evaluation and analysis of clinical data']}, {'label': 'After', 'description': 'Children and adults with FD/MAS who visited at least once in our center (outpatient and hospitalized patients).\n\nand with the first visit in the center included between 2007 and 2019 - after certification of our center.', 'interventionNames': ['Other: Evaluation and analysis of clinical data']}], 'interventions': [{'name': 'Evaluation and analysis of clinical data', 'type': 'OTHER', 'description': "Evaluation and analysis of clinical data (baseline demographic features (sex, age at diagnosis, age at first symptoms, age at first visit), initial presenting symptoms, affected bone sites (monostotic FD or polyostotic FD), renal phosphate wasting, MAS, Mazabraud syndrome, endocrine disease, fractures, bone specific treatment especially bisphosphonate and surgery, pain and disease's severity.", 'armGroupLabels': ['After', 'Before']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69003', 'city': 'Lyon', 'country': 'France', 'facility': 'rheumatology department, hopital Edouard Herriot', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}