Ignite Creation Date:
2025-12-25 @ 5:01 AM
Ignite Modification Date:
2025-12-26 @ 4:02 AM
Study NCT ID:
NCT05719818
Status:
COMPLETED
Last Update Posted:
2023-02-09
First Post:
2022-12-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Dental Care and Initiation of Anti-osteoporotic Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D010024', 'term': 'Osteoporosis'}], 'ancestors': [{'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004164', 'term': 'Diphosphonates'}, {'id': 'D003729', 'term': 'Dental Care'}], 'ancestors': [{'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D003813', 'term': 'Dentistry'}, {'id': 'D003752', 'term': 'Dental Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 338}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2022-01-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-30', 'studyFirstSubmitDate': '2022-12-27', 'studyFirstSubmitQcDate': '2023-01-30', 'lastUpdatePostDateStruct': {'date': '2023-02-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients requiring surgical dental care', 'timeFrame': '15 months', 'description': 'describe the number of patients requiring surgical dental care before to start osteoporosis treatment vs the number of patients with a satisfactory oral assessment authorizing the immediate prescription of treatment'}], 'secondaryOutcomes': [{'measure': 'Impact of dental care on osteoporosis treatment', 'timeFrame': 'Change from baseline', 'description': 'Delay of treatment implementation (in days)'}, {'measure': 'Impact of dental care on osteoporosis treatment', 'timeFrame': 'Change from baseline', 'description': 'New osteoportic fracture occurence (in day since treatment start)'}, {'measure': 'Impact of dental care on osteoporosis treatment', 'timeFrame': 'Change from baseline', 'description': 'Dental complications apperance'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dental Condition', 'Osteoporosis']}, 'descriptionModule': {'briefSummary': 'The initiation of bisphosphonate therapy for osteoporosis requires an assessment of the oral status to prevent the risk of osteonecrosis of the jaw. This recommendation is sometimes a hindrance to the initiation of treatment or may be responsible for a delay in treatment or even the failure to initiate treatment. However, in the case of a severe osteoporotic fracture (femoral or humeral neck fracture, vertebral fracture or pelvic fracture), treatment must be rapid because of the major risk of refracture in the short term (multiplied by 5 in the 2 years following the fracture).\n\nIn the rheumatology department of the Nice University Hospital, the investigator team take care of patients with osteoporotic fractures either directly in hospital or referred by the orthopedics department as part of a care program. For these patients, the team perform an etiological assessment, bone densitometry and evaluation of the oral status with dental panoramic and tele-expertise to determine if there is an indication to perform surgical care before starting the treatment.\n\nTherefore, the investigator aimed to describe the number of patients requiring dental surgery befor the initiation of bisphosphonate or denosumab treatment before to introduce treatment for osteoporosis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients hospitalized in the rhumatologic department - Nice University hospital for osteoporotic fracture and for who the treatment, either bisphosphonate or denosumab, has justified a dental evaluation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* osteoporotic fracture requiring treatment with bisphosphonate or denosumab\n\nExclusion Criteria:\n\n* osteoporotic fracture requiring teriparatide treatment'}, 'identificationModule': {'nctId': 'NCT05719818', 'briefTitle': 'Dental Care and Initiation of Anti-osteoporotic Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nice'}, 'officialTitle': 'Dental Care and Initiation of Anti-osteoporotic Therapy', 'orgStudyIdInfo': {'id': '22Rhumato04'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Treatment initiation', 'description': 'patients with a satisfactory oral assessment authorizing the immediate prescription of treatment.', 'interventionNames': ['Drug: biphosphonates']}, {'label': 'Surgical dental care', 'description': 'patients requiring surgical dental care before treatment initaition.', 'interventionNames': ['Procedure: Dental care']}], 'interventions': [{'name': 'biphosphonates', 'type': 'DRUG', 'description': 'Initiation of bisphosphonate therapy', 'armGroupLabels': ['Treatment initiation']}, {'name': 'Dental care', 'type': 'PROCEDURE', 'description': 'Surgical dental care', 'armGroupLabels': ['Surgical dental care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06000', 'city': 'Nice', 'state': 'CHUN', 'country': 'France', 'facility': 'CHU de NICE', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Not scheduled'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nice', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}