Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2025-12-26 @ 12:27 AM
Study NCT ID:
NCT02194660
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-16
First Post:
2014-07-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Fragility Fracture Liaison Service Project
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010024', 'term': 'Osteoporosis'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D055118', 'term': 'Medication Adherence'}], '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'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D010349', 'term': 'Patient Compliance'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}, 'targetDuration': '24 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-14', 'studyFirstSubmitDate': '2014-07-16', 'studyFirstSubmitQcDate': '2014-07-17', 'lastUpdatePostDateStruct': {'date': '2024-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-07-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bone Mineral Density test within 8 weeks of enrollments', 'timeFrame': '8 weeks', 'description': 'Capture the fracture campaign provide 13 best practice standards. The above mentioned index is the limiting factor for many osteoporosis related managements after fracture. We decided to use this as the primary outcome'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Fractures Liaison Service', 'Osteoporosis', 'Fracture', 'Medication adherence'], 'conditions': ['Osteoporosis', 'Fracture']}, 'descriptionModule': {'briefSummary': "Aims: to Establish the FLS services at the National Taiwan University Hospital (NTUH) and its Beihu Branch (BB).\n\nMethod: From Jan., 2014, two related fracture liaison services (FLSs) following the 13 'Capture the Fracture Best Practice Standards' were implemented at the National Taiwan University Hospital (NTUH) health care system. The main hospital (MH) program enrolled patient with 1) new hip fracture 2) newly identified radiographic vertebral fractures or 3) clinical vertebral fractures from both inpatients and outpatients. The Beihu branch (BB) program enrolled only the later two types of patients from outpatients. During the whole study period, two programs planed to enroll 600 fracture patients. Each patient would be assessed at baseline, and every 4 month for at least one year.", 'detailedDescription': "Background:The Asia Fracture Gap Taiwan Study (AFGTS) showed that among fragility fracture sufferers, only 1/4 of them underwent bone mineral density (BMD) tests and 1/3 of them received treatments for osteoporosis. Secondary fragility fracture prevention services are needed to improve the care gaps\n\n. Aims: to Establish the FLS services at the National Taiwan University Hospital (NTUH) and its Beihu Branch (BB).\n\nMethod: The FLS was designed following the 13 'Capture the Fracture Best Practice Standards'. The National Taiwan University Hospital (NTUH) institutional review board approved the study in Jan., 2014. Patients were eligible to be enrolled into the main hospital (MH) service if they had\n\n1. new hip fracture in orthopedic ward\n2. newly identified radiographic vertebral fractures from plan films in geriatric ward or\n3. clinical vertebral fractures in outpatient clinics.\n\nPatients in outpatient clinics of BB were eligible to be enrolled if they had (1) clinical vertebral fractures or (2) newly identified asymtomatic radiological vertebral fractures by a routine weekly review of every plan film of thoracic or lumbar spine regardless of the reason for it.They were excluded from the service if they had life expectancy shorter than 2 years of life or not be able to complete study assessments for communication or cognitive problems.\n\nOsteoporosis-related assessments, treatments, consultations on diet, medications, exercise, fall prevention were given mainly by care managers. A system is set up to remind patients to take their medications at home or to return to clinic for regular injections of medications. Follow up assessments included adherence to education instructions, medications, fall and fracture incidences. During the whole study period, we planed to enroll 600 fracture patients. Each patient would be assessed at baseline, and every 4 months last for two years.\n\nAnticipated results:\n\nEstablish domestic FLS model and database Publish preliminary results at the 2014 the IOF 5th Regionals Asia Pacific Meeting in Taipei in November.\n\nParticipating physicians and care managers will learn new skills in managing osteoporosis patients.\n\nApplication for Best Practice Recognition for the IOF Capture the Fracture Campaign\n\nPreliminary results:\n\nWe have enrolled 371 eligible patients into FLS services. From the NTUH program, BMD tests were completed within 8 weeks for over 90% of participants. Also, anti-osteoporosis medication (AOMs) were prescribed to about 90% of participants eligible for National Health Insurance reimbursements.\n\nIn 2014, National Taiwan University Hospital (NTUH) and its BeiHu Branch (BB) were awarded the gold medal and silver medal accredited best practice programs from the 'Capture the Fracture' campaign from International Osteoporosis Foundation, respectively.\n\nOur preliminary results were presented at annual scientific meeting of the Taiwanese Osteoporosis Association, at Madrid, Spain, and the IOF 5th Regionals Asia Pacific Meeting in Taipei, Taiwan, and the World Congress on Osteoporosis, Osteoarthritis and Musculoskeletal Diseases, at Milan, Italy."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'new fragility fracture', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria: (Main hospital)\n\n* age \\>=50 years and\n* new hip fracture in orthopedic ward\n* newly identified radiographic vertebral fractures from plan films in geriatric ward\n* clinical vertebral fractures in outpatient clinics Inclusion criteria (Beihu branch, only outpatients)\n* age \\>=50 years and\n* newly identified radiographic vertebral fractures from plan films\n* clinical vertebral fractures\n\nExclusion Criteria:\n\n* fracture is sufer from trauma or cancer\n* atypical fractures\n* Life expectancy less than 2 years or can't be assessed for communication or cognitive problems\n* patient in other medication clinical trials"}, 'identificationModule': {'nctId': 'NCT02194660', 'briefTitle': 'Fragility Fracture Liaison Service Project', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Fragility Fracture Liaison Service Project', 'orgStudyIdInfo': {'id': '201311048RINC'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'M- main hospital', 'description': 'Patient enrolled in the main hospital'}, {'label': 'B- Beihu branch', 'description': 'Patients enrolled in the Beihu branch'}]}, 'contactsLocationsModule': {'locations': [{'zip': '100', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Ding-Cheng Chan Chan, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Taiwan University Hospital Chu-Tung Branch'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}