Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2026-06-09 @ 10:44 AM
Study NCT ID:
NCT02958020
Status:
RECRUITING
Last Update Posted:
2021-09-23
First Post:
2016-11-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multicenter Cohort Study on Osteoporosis
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': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'DNA from blood cells will be preserved for specific study including SNP ananlyses.Tongue coating and feces will be preserved for microflora analyses.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2028-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-21', 'studyFirstSubmitDate': '2016-11-03', 'studyFirstSubmitQcDate': '2016-11-04', 'lastUpdatePostDateStruct': {'date': '2021-09-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'changes in bone mineral density from baseline to 2, 4, 6, 8 and 10 years after enrollment', 'timeFrame': 'at enrollment, and 2, 4, 6, 8 and 10 years after enrollment', 'description': 'lumbar (L1-4 as well as total) and hip bone mineral density will be recorded by dual energy X-ray absorptiometry.'}], 'secondaryOutcomes': [{'measure': 'fracture questionnaire', 'timeFrame': 'at enrollment, and 2, 4, 6, 8 and 10 years after enrollment', 'description': 'information about fracture including cause, time, skeletal site and therapy during the follow-up period will be collected through fracture questionnaire'}, {'measure': 'serum osteocalcin', 'timeFrame': 'at enrollment, and 2, 4, 6, 8 and 10 years after enrollment'}, {'measure': 'serum procollagen type I N-terminal propeptide (PINP)', 'timeFrame': 'at enrollment, and 2, 4, 6, 8 and 10 years after enrollment'}, {'measure': 'serum bone alkaline phosphatase (BALP)', 'timeFrame': 'at enrollment, and 2, 4, 6, 8 and 10 years after enrollment'}, {'measure': 'serum β-crosslaps (β-CTX)', 'timeFrame': 'at enrollment, and 2, 4, 6, 8 and 10 years after enrollment'}, {'measure': 'serum Ca', 'timeFrame': 'at enrollment, and 2, 4, 6, 8 and 10 years after enrollment'}, {'measure': 'serum P', 'timeFrame': 'at enrollment, and 2, 4, 6, 8 and 10 years after enrollment'}, {'measure': 'serum Mg', 'timeFrame': 'at enrollment, and 2, 4, 6, 8 and 10 years after enrollment'}, {'measure': 'serum fibroblast growth factor (FGF)23', 'timeFrame': 'at enrollment, and 2, 4, 6, 8 and 10 years after enrollment'}, {'measure': 'serum parathormone (PTH)', 'timeFrame': 'at enrollment, and 2, 4, 6, 8 and 10 years after enrollment'}, {'measure': 'serum total 25(OH) vitamin D', 'timeFrame': 'at enrollment, and 2, 4, 6, 8 and 10 years after enrollment'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cohort, osteoporosis, bone mineral density, Chinese'], 'conditions': ['Osteoporosis']}, 'referencesModule': {'references': [{'pmid': '31767578', 'type': 'DERIVED', 'citation': 'Wang J, Shu B, Li CG, Xie XW, Liang D, Chen BL, Lin XC, Wei X, Wang L, Leng XY, Zhou YJ, Chen PZ, Tao YR, Zhou Y, Zhang Y, Cui XJ, Lu S, Wang H, Shi Q, Wang YJ. Polymorphisms of genes related to vitamin D metabolism and transportation and its relationship with the risk of osteoporosis: protocol for a multicentre prospective cohort study in China. BMJ Open. 2019 Nov 24;9(11):e028084. doi: 10.1136/bmjopen-2018-028084.'}, {'pmid': '31278103', 'type': 'DERIVED', 'citation': 'Wang J, Chen L, Zhang Y, Li CG, Zhang H, Wang Q, Qi X, Qiao L, Da WW, Cui XJ, Lu S, Wang YJ, Shu B. Association between serum vitamin B6 concentration and risk of osteoporosis in the middle-aged and older people in China: a cross-sectional study. BMJ Open. 2019 Jul 4;9(7):e028129. doi: 10.1136/bmjopen-2018-028129.'}]}, 'descriptionModule': {'briefSummary': 'This is a multicenter cohort study on osteoporosis in nine cities of China which locate in the east, south, north, west, middle of China. At least 3000 middle-aged and elderly permanent residents (women aged from 45 to 79, and men aged from 50 to 79) in every city will be enrolled. Residents with severe mental diseases, physical diseases or acute infectious diseases who could not cooperate with the survey as well as lactating or pregnant women were excluded. All the enrolled residents who signed informed consent will finish questionnaire including demographic characteristics, history of smoking, alcohol drinking, falls and fracture, family genetic history, chronic diseases and medicine,diary and physical practice，stool and urine status. Osteoporosis risk, health status, constitution of traditional Chinese medicine (TCM),symptoms of kidney yang deficiency in TCM，living environment,sweating status will be evaluated. Fasting blood glucose test and other blood tests for liver and kidney function,bone metabolism，vitamins，vitamin D metabolism and transportation as well as calcium and phosphate metabolism, will be performed. Bone mineral density and physical examinations (height, weight, waist circumference, hip circumference,grip,sit-to-stand test, tongue coating and pulse) will also be performed at enrollment and every two years after enrollment. DNA of blood cells will be preserved for specific study such as SNP analyses.Tongue coating and feces will be preserved for microflora analyses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '45 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Nine cities which locate in the east, south, north, west and middle of China were involved. In each city, at least 3000 middle-aged and elderly permanent residents were enrolled.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* permanent residents\n* women aged from 45 to 79, and men aged from 50 to 79\n\nExclusion Criteria:\n\n* severe mental diseases, physical diseases or acute infectious diseases who could not cooperate with the survey.\n* lactating or pregnant women.'}, 'identificationModule': {'nctId': 'NCT02958020', 'briefTitle': 'Multicenter Cohort Study on Osteoporosis', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai University of Traditional Chinese Medicine'}, 'officialTitle': 'Multicenter Cohort Study on Osteoporosis in the Middle-aged and Elderly People in Shanghai, China', 'orgStudyIdInfo': {'id': 'osteoporosis cohort'}}, 'contactsLocationsModule': {'locations': [{'city': 'Shenzhen', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Baolin Li', 'role': 'CONTACT', 'phone': '13923865111'}], 'facility': 'Shenzhen Pingle Orthopedic Hospital', 'geoPoint': {'lat': 22.54554, 'lon': 114.0683}}, {'city': 'Ganzhou', 'state': 'Jiangxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yuping Zeng', 'role': 'CONTACT', 'phone': '13970701683'}], 'facility': "First People's Hospital of Nankang District, Ganzhou City", 'geoPoint': {'lat': 25.84664, 'lon': 114.9326}}, {'city': 'Jinan', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wei Shi', 'role': 'CONTACT', 'phone': '15153165961'}], 'facility': 'Shandong Provincial Hospital of Traditional Chinese Medicine', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'city': 'Kunming', 'state': 'Yunnan', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lijuan Jiang', 'role': 'CONTACT', 'phone': '13668781266'}], 'facility': 'Yunnan Provincial Hospital of Traditional Chinese Medicine', 'geoPoint': {'lat': 25.03889, 'lon': 102.71833}}, {'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xinchao Lin', 'role': 'CONTACT'}], 'facility': 'Dongzhimen Hospital, Beijing', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yanming Xie', 'role': 'CONTACT'}], 'facility': 'Wangjing Hospital, China Academy of Chinese Medical Sciences', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Changchun', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiangyang Leng', 'role': 'CONTACT'}], 'facility': 'Affiliated Hospital of Changchun University of Traditional Chinese Medicine', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}, {'city': 'Guangzhou', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Bolai Chen', 'role': 'CONTACT'}], 'facility': 'Guangdong Provincial Hospital of Traditional Chinese Medicine', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Guangzhou', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jiangtao Xie', 'role': 'CONTACT'}], 'facility': 'Guangzhou Kingmed Diagnostics Co., Ltd.', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Guangzhou', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'De Liang', 'role': 'CONTACT'}], 'facility': 'The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Lanzhou', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xingwen Xie', 'role': 'CONTACT'}], 'facility': 'Gansu Provincial Hospital of Traditional Chinese Medicine', 'geoPoint': {'lat': 36.05701, 'lon': 103.83987}}, {'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yongjun Wang', 'role': 'CONTACT'}], 'facility': 'Longhua Hospital, Shanghai University of TCM', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Yongjun Wang', 'role': 'CONTACT', 'email': 'yjwang88@hotmail.com', 'phone': '86-21-64385700', 'phoneExt': '9903'}], 'overallOfficials': [{'name': 'Yongjun Wang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shanhgai University of TCM'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai University of Traditional Chinese Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Wangjing Hospital, China Academy of Chinese Medical Sciences', 'class': 'OTHER'}, {'name': 'Dongzhimen Hospital, Beijing', 'class': 'OTHER'}, {'name': 'The First Affiliated Hospital of Guangzhou University of TCM', 'class': 'UNKNOWN'}, {'name': 'Guangdong Provincial Hospital of Traditional Chinese Medicine', 'class': 'OTHER'}, {'name': 'Affiliated Hospital of Changchun University of Chinese Medicine', 'class': 'OTHER'}, {'name': 'Gansu Provincial Hospital', 'class': 'OTHER'}, {'name': 'Guangzhou Kingmed Diagnostics Co., Ltd.', 'class': 'UNKNOWN'}, {'name': 'Affiliated Hospital of Shandong University of Traditional Chinese Medicine', 'class': 'OTHER'}, {'name': 'Yunnan Provincial Hospital of Traditional Chinese Medicine', 'class': 'UNKNOWN'}, {'name': 'Shenzhen Pingle Orthopedic Hospital', 'class': 'UNKNOWN'}, {'name': "First People's Hospital of Nankang District, Ganzhou City", 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Bing Shu', 'investigatorAffiliation': 'Shanghai University of Traditional Chinese Medicine'}}}}