Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2026-02-25 @ 8:31 PM
Study NCT ID:
NCT05848167
Status:
UNKNOWN
Last Update Posted:
2023-11-22
First Post:
2023-04-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Senile Osteoporotic Fractures Cohort Study（SOFCS）
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058866', 'term': 'Osteoporotic Fractures'}], 'ancestors': [{'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2024-07-14', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-20', 'studyFirstSubmitDate': '2023-04-26', 'studyFirstSubmitQcDate': '2023-05-05', 'lastUpdatePostDateStruct': {'date': '2023-11-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bone mineral density', 'timeFrame': 'two years', 'description': 'BMD'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Senile osteoporotic fracture,Cohort study,mechanism,outcome'], 'conditions': ['Osteoporotic Fractures']}, 'descriptionModule': {'briefSummary': 'Osteoporotic fracture is one of the main causes of disability and death in elderly patients. Specific disease cohort study is an important basis for accurate prevention and treatment of senile osteoporotic fractures. Investigators plan to collect and manage the baseline and clinical information of more than 2000 elderly patients with osteoporotic fractures after surgery through the platform of special disease collaborative prevention and treatment system and medical record database of Suzhou Municipal Hospital in two years, and carry out short-term and long-term follow-up observation.', 'detailedDescription': 'Osteoporotic fracture is one of the main causes of disability and death in elderly patients. Compared with patients with no history of fractures, the risk of a second fracture after an initial fracture doubled, with a fatality rate of up to 34.8%. There has been a lot of progress in the diagnosis and treatment of osteoporotic fractures in the elderly. However, there are few reports on the diagnosis and treatment of osteoporotic fractures in the elderly after surgery. Based on previous studies, it is found that the re-fracture after operation of osteoporotic fracture in the elderly is not only directly caused by the fall, but also caused by the interaction of multiple risk factors including environmental factors, physiological factors and neuroskeletal musculoskeletal system. Therefore, it is of great significance to break the traditional diagnosis and treatment mode, improve the diagnosis and treatment effect, and save medical resources to carry out research on the disease characteristics, rules and risk warning after senile osteoporotic fracture operation. Specific disease cohort study is an important basis for accurate prevention and treatment of senile osteoporotic fractures. Investigators plan to collect and manage the baseline and clinical information of more than 2000 elderly patients with osteoporotic fractures after surgery through the platform of special disease collaborative prevention and treatment system and medical record database of Suzhou Municipal Hospital in two years, and carry out short-term and long-term follow-up observation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Elderly patients after operation of osteoporotic fracture.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patients ≥65 years old\n2. Patients with osteoporosis\n3. No gender limitation\n\nExclusion Criteria:\n\n1. \\< 65 years old;\n2. Non-osteoporotic fracture;\n3. Alzheimer's disease;\n4. Bone tumors."}, 'identificationModule': {'nctId': 'NCT05848167', 'briefTitle': 'Senile Osteoporotic Fractures Cohort Study（SOFCS）', 'organization': {'class': 'OTHER', 'fullName': 'Suzhou Municipal Hospital'}, 'officialTitle': 'Senile Osteoporotic Fractures Cohort Study', 'orgStudyIdInfo': {'id': 'GSKY20210404'}}, 'contactsLocationsModule': {'locations': [{'zip': '215000', 'city': 'Suzhou', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hao Y feng, doctor', 'role': 'CONTACT', 'email': '13913109339@163.com', 'phone': '13913109339'}, {'name': 'Che Y jun, doctor', 'role': 'CONTACT', 'email': 'cheyanjun1980@hotmail.com', 'phone': '19941919699'}], 'facility': 'Suzhou Municipal Hospital', 'geoPoint': {'lat': 31.30408, 'lon': 120.59538}}], 'centralContacts': [{'name': 'Hao Y feng, doctor', 'role': 'CONTACT', 'email': '13913109339@163.com', 'phone': '13913109339'}, {'name': 'Che Y jun, doctor', 'role': 'CONTACT', 'email': 'cheyanjun1980@hotmail.com', 'phone': '19941919699'}], 'overallOfficials': [{'name': 'Hao Y feng, doctor', 'role': 'STUDY_CHAIR', 'affiliation': 'Suzhou Municipal Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Suzhou Municipal Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Mo Zhou', 'investigatorAffiliation': 'Suzhou Municipal Hospital'}}}}