Ignite Creation Date:
2025-12-24 @ 4:57 PM
Ignite Modification Date:
2025-12-27 @ 2:01 PM
Study NCT ID:
NCT05688150
Status:
COMPLETED
Last Update Posted:
2024-02-20
First Post:
2022-12-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevalence and Associated Factors of Sarcopenia Among Elderly Patients in Osteoporosis Clinic
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055948', 'term': 'Sarcopenia'}, {'id': 'D010024', 'term': 'Osteoporosis'}], 'ancestors': [{'id': 'D009133', 'term': 'Muscular Atrophy'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001284', 'term': 'Atrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'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': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 94}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2023-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-16', 'studyFirstSubmitDate': '2022-12-21', 'studyFirstSubmitQcDate': '2023-01-13', 'lastUpdatePostDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of Sarcopenia', 'timeFrame': 'June - December 2022', 'description': 'The diagnosis of sarcopenia would be established by the co-existence of low grip strength and low appendicular skeletal muscle mass.'}, {'measure': 'Grip strength', 'timeFrame': 'June - December 2022', 'description': 'Grip strength would be measured with Jamar digital dynamometer.'}, {'measure': 'Appendicular Skeletal Muscle Mass Index', 'timeFrame': 'June - December 2022', 'description': 'Appendicular Skeletal Muscle Mass Index would be measured with bioimpedance analyzer.'}], 'secondaryOutcomes': [{'measure': 'Association between BMI and Sarcopenia.', 'timeFrame': 'June - December 2022', 'description': 'BMI would be measured on clinic attendance.'}, {'measure': 'Association between Frailty and Sarcopenia.', 'timeFrame': 'June - December 2022', 'description': 'Clinical Frailty Scale would be documented in clinical consultation.'}, {'measure': 'Association between Charlson Comorbidities Index and Sarcopenia', 'timeFrame': 'June - December 2022', 'description': 'Components of Charlson Comorbidities Index would be extracted from medical record.'}, {'measure': 'Association between Bone Mineral Densities and Sarcopenia', 'timeFrame': 'June - December 2022', 'description': 'Bone mineral densities of spine and neck of femur would be extracted from the report of dual-energy X-ray absorptiometry.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['osteosarcopenia', 'sarcopenia', 'osteoporosis', 'geriatric medicine'], 'conditions': ['Sarcopenia', 'Osteoporosis']}, 'referencesModule': {'references': [{'pmid': '32033882', 'type': 'BACKGROUND', 'citation': 'Chen LK, Woo J, Assantachai P, Auyeung TW, Chou MY, Iijima K, Jang HC, Kang L, Kim M, Kim S, Kojima T, Kuzuya M, Lee JSW, Lee SY, Lee WJ, Lee Y, Liang CK, Lim JY, Lim WS, Peng LN, Sugimoto K, Tanaka T, Won CW, Yamada M, Zhang T, Akishita M, Arai H. Asian Working Group for Sarcopenia: 2019 Consensus Update on Sarcopenia Diagnosis and Treatment. J Am Med Dir Assoc. 2020 Mar;21(3):300-307.e2. doi: 10.1016/j.jamda.2019.12.012. Epub 2020 Feb 4.'}]}, 'descriptionModule': {'briefSummary': 'This was a cross-sectional study. Patients who attended the osteoporosis clinic of Kowloon Hospital from June to December 2022 were recruited.\n\nGrip strength and appendicular skeletal muscle mass index were measured with a Jamar dynamometer and a bioimpedance analyser. Since most patients in our clinic are of Chinese ethnicity, the diagnostic criteria in the Consensus Update on Sarcopenia Diagnosis and Treatment by the Asian Working Group for Sarcopenia in 2019 was utilised. The diagnosis of sarcopenia was established by the presence of both low grip strength (Male: \\< 28 kg, Female \\< 18 kg) and low appendicular skeletal mass (Male: \\< 7.0 kg/m2, Female: \\< 5.7 kg/m2)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who attended the osteoporosis clinic of Kowloon Hospital from June to December 2022.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 60 years old or above\n* Diagnosed with osteoporosis by: Fragility fracture or T-score ≤-2.5 SDs at any site on DXA scan and;\n* Able to read and write Chinese\n\nExclusion Criteria:\n\n* Unable to maintain standing posture for bioimpedance analysis\n* Modified Functional Ambulation Classification (MFAC) ≤ IV\n* Incompetent in giving consent\n* Unable to follow instructions\n* Implanted with metal in any of four limbs\n* Implanted with pacemaker, implantable cardioverter defibrillator or any other types of electrical device'}, 'identificationModule': {'nctId': 'NCT05688150', 'briefTitle': 'Prevalence and Associated Factors of Sarcopenia Among Elderly Patients in Osteoporosis Clinic', 'organization': {'class': 'OTHER', 'fullName': 'Kowloon Hospital, Hong Kong'}, 'officialTitle': 'Prevalence and Associated Factors of Sarcopenia Among Elderly Patients in Osteoporosis Clinic', 'orgStudyIdInfo': {'id': 'KHRehab_LeungHC_1'}}, 'contactsLocationsModule': {'locations': [{'city': 'Kowloon', 'country': 'Hong Kong', 'facility': 'Kowloon Hospital', 'geoPoint': {'lat': 22.31667, 'lon': 114.18333}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kowloon Hospital, Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Leung Hin Cheung', 'investigatorAffiliation': 'Kowloon Hospital, Hong Kong'}}}}