Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2026-02-21 @ 7:51 AM
Study NCT ID:
NCT06621069
Status:
COMPLETED
Last Update Posted:
2024-10-01
First Post:
2024-09-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Long-term Use of Bisphosphonates on Femur Morphology
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004164', 'term': 'Diphosphonates'}], 'ancestors': [{'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-27', 'studyFirstSubmitDate': '2024-09-24', 'studyFirstSubmitQcDate': '2024-09-27', 'lastUpdatePostDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'femoral lateral bowing', 'timeFrame': 'through study completion, an average of 8 years', 'description': 'Angle between axes of 20% proximal and distal sections of femur diaphysis'}], 'secondaryOutcomes': [{'measure': 'femoral neck shaft angle (FNSA)', 'timeFrame': 'through study completion, an average of 8 year', 'description': 'Angle between the femoral neck axis and mechanical axis of the femur'}, {'measure': 'hip knee shaft angle', 'timeFrame': 'through study completion, an average of 8 years', 'description': 'Angle between mechanical and anatomical femoral axes'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['bisphosphonates', 'atypical femur fracture'], 'conditions': ['Osteoporosis', 'Knee Osteoarthristis']}, 'descriptionModule': {'briefSummary': 'Recent studies have shown that bone modeling can occur throughout life, suggesting bone has a persistent ability of adapting structure to loading. Some bone medications have a significant effect on the process of bone modeling based on histological studies. Bisphosphonates (BP), a classical anti-resorption drug which impacts the process of bone turnover, is related with atypical femur fractures while the mechanism is unclear. Several hypotheses are considered competitive. Among them, increased femur bowing is associated with atypical femoral fractures. However, it remains doubtful whether long-term BP use increases femur bowing. Thus, the investigators design this retrospective cohort study.', 'detailedDescription': 'If the participants meet the Inclusion Criteria, the investigators will collect the baseline characteristics of patients including age, gender, body mass index (BMI), as well as characteristics of BMD by dual-energy X-ray absorptiometry (DXA), BP treatment (type of drugs, duration before baseline). The primary outcome was femoral lateral bowing (FLB), femoral neck shaft angle (FNSA), and hip knee shaft angle (HKSA) from the frontal plane in standing radiographs of the lower limbs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients are mostly from Zhejiang Province', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* standing radiographs of the lower limb\n\nExclusion Criteria:\n\n* non-standard lower limbs X-ray , rheumatoid arthritis, tumor of the femur， congenital anomalies of the lower extremity'}, 'identificationModule': {'nctId': 'NCT06621069', 'briefTitle': 'The Effect of Long-term Use of Bisphosphonates on Femur Morphology', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, 'officialTitle': 'The Effect of Long-term Use of Bisphosphonates on Femur Morphology', 'orgStudyIdInfo': {'id': '2024-0641'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patients with over 5-year BP history', 'description': 'patients who took bisphosphonates over 5 years', 'interventionNames': ['Drug: Bisphosphonates']}, {'label': 'control patients without BP usage', 'description': 'patients who do not receive bisphosphonates therapy', 'interventionNames': ['Other: Control']}], 'interventions': [{'name': 'Bisphosphonates', 'type': 'DRUG', 'description': 'Alendronate Sodium or Zoledronic acid', 'armGroupLabels': ['patients with over 5-year BP history']}, {'name': 'Control', 'type': 'OTHER', 'description': 'control without BP', 'armGroupLabels': ['control patients without BP usage']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310058', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': '1. Department of Orthopedics Surgery, The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}