Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2025-12-25 @ 9:55 PM
Study NCT ID:
NCT03402958
Status:
COMPLETED
Last Update Posted:
2018-09-21
First Post:
2018-01-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
General Practitioner's Place in the Treatment of Fracture Osteoporosis in the Elderly
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': 'ACTUAL', 'count': 160}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2018-03-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-20', 'studyFirstSubmitDate': '2018-01-10', 'studyFirstSubmitQcDate': '2018-01-17', 'lastUpdatePostDateStruct': {'date': '2018-09-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of prescription of anti-osteoporosis treatments.', 'timeFrame': '6 months after surgical management for fracture of the upper end of the femur'}], 'secondaryOutcomes': [{'measure': 'Factors associated with the sub-prescription.', 'timeFrame': 'Through study completion, an average of 4 months', 'description': 'The main factors associated with non-prescription found are co-morbidities (charlson score\\> 6), dementia, obesity (BMI\\> 30), chronic alcoholism, male sex, polypharmacy\\> 4, age. Conversely, the factors associated with prescribing are recurrent falls (\\> 2 / year), a history of osteoporotic fracture, an Iso Resource Group\\> 3, female sex, and corticosteroid therapy.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Osteoporosis']}, 'descriptionModule': {'briefSummary': 'Osteoporosis is a major public health problem. Its screening and its treatment remain largely insufficient while therapies have demonstrated their effectiveness. In the event of a severe fracture, the update of the 2016/2017 recommendations, prepared by the Research and Information Group on Osteoporosis and the French Rheumatology Society, concerning osteoporosis recommends a specific treatment with bisphosphonates as first-line treatment, without bone densitometry, regardless of age. The frequency of prescribing anti-osteoporotic treatment as an outpatient after a fracture of the upper extremity of the femur is very low (2% to 21% according to the studies). The main factors associated with non-prescription found are co-morbidities (charlson score\\> 6), dementia, obesity (BMI\\> 30), chronic alcoholism, male sex, polypharmacy\\> 4, age. Conversely, the factors associated with prescribing are recurrent falls (\\> 2 / year), a history of osteoporotic fracture, an Iso Resource Group\\> 3, female sex, and corticosteroid therapy.', 'detailedDescription': "1. / The collection of patients' characteristics upon admission will be based on the computerized patient file and the paper file: socio-demographic data, co-morbidities, functional status, entry / exit treatments, place of residence, source, balance sheet hospital.\n2. / Determination with the treating doctor or the pharmacist of the prescriptions of the anti-osteoporotic treatments at 6 months of the hospital care.\n3. / Research factors associated with the prescription (or non-prescription) of anti-osteoporotic treatments."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '75 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients treated for a fracture of the upper extremity of the femur, included consecutively and retrospectively, during the period of October 2016 - June 2017 at the Saint-Malo Hospital Center', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects aged 75 or over (hospitalization criteria in the pathway), admitted to the ortho-geriatric ward of the Saint Malo Hospital Center, treated for a fracture of the upper extremity of the femur.\n\nExclusion Criteria:\n\n* High-energy fracture, pathological fractures (infection, tumor), persons of legal age subject to legal protection (safeguard of justice, guardianship, guardianship), persons deprived of their liberty.'}, 'identificationModule': {'nctId': 'NCT03402958', 'acronym': 'GEOFRAGE', 'briefTitle': "General Practitioner's Place in the Treatment of Fracture Osteoporosis in the Elderly", 'organization': {'class': 'OTHER', 'fullName': 'Rennes University Hospital'}, 'officialTitle': "General Practitioner's Place in the Treatment of Fracture Osteoporosis in the Elderly", 'orgStudyIdInfo': {'id': '35RC17_309_GEOFRAGE'}}, 'contactsLocationsModule': {'locations': [{'zip': '35400', 'city': 'St-Malo', 'state': 'Britain', 'country': 'France', 'facility': 'Hospital Center of Saint-Malo', 'geoPoint': {'lat': 48.64738, 'lon': -2.00877}}], 'overallOfficials': [{'name': 'Nicolas Belhomme', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rennes University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rennes University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}