Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-27 @ 4:54 AM
Study NCT ID:
NCT05781594
Status:
UNKNOWN
Last Update Posted:
2023-03-23
First Post:
2023-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Family Cohort Study on Primary Osteoporosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Serum, saliva'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2023-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-10', 'studyFirstSubmitDate': '2023-02-05', 'studyFirstSubmitQcDate': '2023-03-10', 'lastUpdatePostDateStruct': {'date': '2023-03-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'changes in bone mineral density from baseline to 5 years after enrollment', 'timeFrame': 'at enrollment', 'description': 'lumbar (L1-4 as well as total) and hip bone mineral density will be recorded by dual energy X-ray absorptiometry'}, {'measure': 'changes in bone mineral density from baseline to 5 years after enrollment', 'timeFrame': '5 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'}, {'measure': 'Physical phenotype of traditional Chinese medicine', 'timeFrame': 'at enrollment', 'description': 'Occurrence of kidney yang deficiency'}, {'measure': 'Physical phenotype of traditional Chinese medicine', 'timeFrame': '5 years after enrollment', 'description': 'Occurrence of kidney yang deficiency'}, {'measure': 'Understand the general situation through the questionnaire', 'timeFrame': 'at enrollment', 'description': 'Including age（year）, sex（man,wowan）, height(cm), weight(kg), menstrual period,history of smoking and drinking, living habits, fracture history and risk assessment, skeletal muscle assessment, living environment, Chinese medicine constitution, etc'}, {'measure': 'Understand the general situation through the questionnaire', 'timeFrame': '5 years after enrollment', 'description': 'Including age（year）, sex（man,wowan）, height(cm), weight(kg), menstrual period,history of smoking and drinking, living habits, fracture history and risk assessment, skeletal muscle assessment, living environment, Chinese medicine constitution, etc'}], 'secondaryOutcomes': [{'measure': 'Osteocalcin', 'timeFrame': 'at enrollment', 'description': 'serum osteocalcin'}, {'measure': 'procollagen type I N-terminal propeptide', 'timeFrame': 'at enrollment', 'description': 'serum procollagen type I N-terminal propeptide (PINP)'}, {'measure': 'Bone alkaline phosphatase', 'timeFrame': 'at enrollment', 'description': 'serum bone alkaline phosphatase (BALP)'}, {'measure': 'β-crosslaps', 'timeFrame': 'at enrollment', 'description': 'serum β-crosslaps (β-CTX)'}, {'measure': 'Ca', 'timeFrame': 'at enrollment', 'description': 'serum Ca'}, {'measure': 'P', 'timeFrame': 'at enrollment', 'description': 'serum P'}, {'measure': 'Mg', 'timeFrame': 'at enrollment', 'description': 'serum Mg'}, {'measure': 'Fibroblast growth factor', 'timeFrame': 'at enrollment', 'description': 'serum fibroblast growth factor (FGF)23'}, {'measure': 'Parathormone', 'timeFrame': 'at enrollment', 'description': 'serum parathormone (PTH)'}, {'measure': '25(OH) vitamin D', 'timeFrame': 'at enrollment', 'description': 'serum total 25(OH) vitamin D'}, {'measure': 'Osteocalcin', 'timeFrame': '5 years after enrollment', 'description': 'serum osteocalcin'}, {'measure': 'Procollagen type I N-terminal propeptide', 'timeFrame': '5 years after enrollment', 'description': 'serum procollagen type I N-terminal propeptide (PINP)'}, {'measure': 'Bone alkaline phosphatase', 'timeFrame': '5 years after enrollment', 'description': 'serum bone alkaline phosphatase (BALP)'}, {'measure': 'β-crosslaps', 'timeFrame': '5 years after enrollment', 'description': 'serum β-crosslaps (β-CTX)'}, {'measure': 'Ca', 'timeFrame': '5 years after enrollment', 'description': 'serum Ca'}, {'measure': 'P', 'timeFrame': '5 years after enrollment', 'description': 'serum P'}, {'measure': 'Mg', 'timeFrame': '5 years after enrollment', 'description': 'serum Mg'}, {'measure': 'Fibroblast growth factor', 'timeFrame': '5 years after enrollment', 'description': 'serum fibroblast growth factor (FGF)23'}, {'measure': 'Parathormone', 'timeFrame': '5 years after enrollment', 'description': 'serum parathormone (PTH)'}, {'measure': '25(OH) vitamin D', 'timeFrame': '5 years after enrollment', 'description': 'serum total 25(OH) vitamin D'}, {'measure': 'Gene testing(BGIseq T5,WGS)', 'timeFrame': 'at enrollment', 'description': 'Carry out whole-gene testing on the samples with obvious family heritability of osteoporosis, and analyze the differences at the gene level through sequencing compared with the control group'}, {'measure': 'Gene testing(BGIseq T5,WGS)', 'timeFrame': '5 years after enrollment', 'description': 'Carry out whole-gene testing on the samples with obvious family heritability of osteoporosis, and analyze the differences at the gene level through sequencing compared with the control group'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Osteoporosis families', 'Kidney-yang deficiency', 'Genetic correlation of disease', 'Bone density'], 'conditions': ['Family Genetic Characteristics of Osteoporosis']}, 'descriptionModule': {'briefSummary': 'Bone metabolism and genetic characteristics of osteoporosis pedigree with kidney-yang deficiency', 'detailedDescription': 'Families with or without osteoporosis of kidney-yang deficiency type will be included and compared with each other. Their genetic characteristics, bone changes, and TCM constitution are the focus of research.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'member of family', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Be able to cooperate with inspection.There is blood relationship between the members of the enrolled family.\n\nExclusion Criteria:\n\n* Unable to cooperate with inspection.There is not blood relationship between the members of the enrolled family.'}, 'identificationModule': {'nctId': 'NCT05781594', 'briefTitle': 'Family Cohort Study on Primary Osteoporosis', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai University of Traditional Chinese Medicine'}, 'officialTitle': 'Family Cohort Study on Primary Osteoporosis With Kidney-yang Deficiency Syndrome', 'orgStudyIdInfo': {'id': 'ShanghaiUTCM20230201'}}, 'contactsLocationsModule': {'locations': [{'zip': '341000', 'city': 'Gannan', 'state': 'Jiangxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhangyu Liao', 'role': 'CONTACT', 'email': '13970708594@163.com', 'phone': '13970708594'}], 'facility': 'Nankang Traditional Chinese Medicine Hospital', 'geoPoint': {'lat': 26.78132, 'lon': 114.99776}}, {'zip': '750000', 'city': 'Yinchuan', 'state': 'Ningxia', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Chuanglong Xu', 'role': 'CONTACT', 'email': 'mqxcl@163.com', 'phone': '17795122519'}], 'facility': 'Ningxia Chinese medicine Rearch Center', 'geoPoint': {'lat': 38.46806, 'lon': 106.27306}}, {'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': 'STUDY_CHAIR', 'affiliation': 'Shanhgai University of TCM'}, {'name': 'Chuanglong Xu', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ningxia Chinese medicine Rearch Center'}, {'name': 'Zhangyu Liao', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Nankang Traditional Chinese Medicine Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai University of Traditional Chinese Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}