Ignite Creation Date:
2025-12-25 @ 1:02 AM
Ignite Modification Date:
2025-12-26 @ 1:40 PM
Study NCT ID:
NCT04709393
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-08-21
First Post:
2021-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of FRAX+SARC-F Pre-screening on Preventing Fragility Fracture and Fall in Community-dwelling Older Adults
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2956}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-05-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-20', 'studyFirstSubmitDate': '2021-01-13', 'studyFirstSubmitQcDate': '2021-01-13', 'lastUpdatePostDateStruct': {'date': '2024-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'proportions of participants diagnosed with osteoporosis in the FRAX+SARC-F pre-screening and control groups.', 'timeFrame': 'within 1-6 months', 'description': 'proportions of participants diagnosed with osteoporosis in the FRAX+SARC-F pre-screening and control groups.'}], 'secondaryOutcomes': [{'measure': 'Rate of receiving osteoporosis screening', 'timeFrame': '6-12 months', 'description': 'Number of participants receiving osteoporosis screening in the arms'}, {'measure': 'rate of receiving fall risk assessment', 'timeFrame': '6-12 months', 'description': 'Number of participants receiving fall risk assessment in the arms'}, {'measure': 'rate of receiving anti-osteoporosis intervention', 'timeFrame': '6-12 months', 'description': 'Number of participants receiving anti-osteoporosis intervention in the arms'}, {'measure': 'rate of receiving fall prevention intervention', 'timeFrame': '6-12 months', 'description': 'Number of participants receiving fall prevention intervention in the arms'}, {'measure': 'subsequent fall rate', 'timeFrame': '12 months', 'description': 'Number of participants having subsequent fall in the arms'}, {'measure': 'subsequent fracture rate', 'timeFrame': '12 months', 'description': 'Number of participants having subsequent fracture in the arms'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Age Related Osteoporosis', 'Fall']}, 'descriptionModule': {'briefSummary': 'Hip fragility fractures are a major threat to functional independence in older adults locally and globally. In Hong Kong, the prevalence of osteoporosis and osteopenia in people aged \\>50 years were reported to be as high as 37% and 52%, respectively. The major challenge in fragility fracture prevention is that fragility fracture is caused by the combination of osteoporosis and propensity to fall, and both of these conditions are multifactorial. Ample evidence shows that fall risks can be reduced by well-designed exercises, and osteoporosis can be effectively diagnosed by Dual-energy X-ray Absorptiometry imaging (DXA) and treated with anti-osteoporosis medication. Lifestyle modifications e.g. diet, optimal physical activity, environmental safety can also help to prevent falls or improve bone health. The brief Fracture Risk Assessment Tool (FRAX) and SARC-F provide a low cost of prescreening for fracture risk and sarcopenia, respectively. Using SARC-F in conjunction with FRAX has increased sensitivity for hip fracture risk prediction. FRAX+SARC-F may help increase the public awareness of osteoporosis and get the at-risk group to receive diagnostic tests and be treated. This model should fit in well with the coming District Health Centres across Hong Kong.', 'detailedDescription': 'Participants will be randomly assigned to either the pre-screening or control group in a 1:1 ratio. Independent personnel not involved in data collection or intervention will perform and conceal the randomization using an online data server. Research assistants who are blinded to the group allocation will conduct all the baseline assessments and subsequent event surveillance. All data will also be entered and checked by the blinded research assistants. All procedures concur with the Declaration of Helsinki (2013).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* aged ≥ 65 years\n* living in the community\n\nExclusion Criteria:\n\n• cannot follow the instruction'}, 'identificationModule': {'nctId': 'NCT04709393', 'briefTitle': 'Effects of FRAX+SARC-F Pre-screening on Preventing Fragility Fracture and Fall in Community-dwelling Older Adults', 'organization': {'class': 'OTHER', 'fullName': 'Chinese University of Hong Kong'}, 'officialTitle': 'The Effects of FRAX+SARC-F Questionnaire Pre-screening on Promoting Public Awareness of Fragility Fracture and Fall Prevention Among Community-dwelling Older Adults', 'orgStudyIdInfo': {'id': '2020.609-T'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pre-screening', 'description': 'Receiving FRAX+SARC-F questionnaire pre-screening results on estimated fracture risk', 'interventionNames': ['Other: FRAX+SARC-F questionnaire pre-screening']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Not receiving FRAX+SARC-F questionnaire pre-screening preliminary results on estimated fracture risk'}], 'interventions': [{'name': 'FRAX+SARC-F questionnaire pre-screening', 'type': 'OTHER', 'description': 'Pre-screening group participants will receive the FRAX+SARC-F questionnaire pre-screening and be notified of the preliminary estimation of their future hip fracture risk before being invited to our DXA screening and fall-risk assessment.', 'armGroupLabels': ['Pre-screening']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'The Chinese University of Hong Kong Jockey Club Centre for Osteoporosis Care and Control', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'overallOfficials': [{'name': 'Timothy Kwok', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Chinese University of Hong Kong Jockey Club Centre for Osteoporosis Care and Control'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Timothy Kwok', 'investigatorAffiliation': 'Chinese University of Hong Kong'}}}}