Clinical trial NCT05781594: Family Cohort Study on Primary Osteoporosis
Official title: Family Cohort Study on Primary Osteoporosis With Kidney-yang Deficiency Syndrome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Family Genetic Characteristics of Osteoporosis
Keywords: Osteoporosis families
Kidney-yang deficiency
Genetic correlation of disease
Bone density
Lead sponsor: Shanghai University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2023-03-23
Enrollment: 600
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: member of family

Brief summary: Bone metabolism and genetic characteristics of osteoporosis pedigree with kidney-yang deficiency

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Be able to cooperate with inspection.There is blood relationship between the members of the enrolled family.

Exclusion Criteria:

* Unable to cooperate with inspection.There is not blood relationship between the members of the enrolled family.

Primary outcomes:
measure: changes in bone mineral density from baseline to 5 years after enrollment
timeFrame: at enrollment
measure: changes in bone mineral density from baseline to 5 years after enrollment
timeFrame: 5 years after enrollment
measure: Physical phenotype of traditional Chinese medicine
timeFrame: at enrollment
measure: Physical phenotype of traditional Chinese medicine
timeFrame: 5 years after enrollment
measure: Understand the general situation through the questionnaire
timeFrame: at enrollment
measure: Understand the general situation through the questionnaire
timeFrame: 5 years after enrollment
Secondary outcomes:
measure: Osteocalcin
timeFrame: at enrollment
measure: procollagen type I N-terminal propeptide
timeFrame: at enrollment
measure: Bone alkaline phosphatase
timeFrame: at enrollment
measure: β-crosslaps
timeFrame: at enrollment
measure: Ca
timeFrame: at enrollment
measure: P
timeFrame: at enrollment
measure: Mg
timeFrame: at enrollment
measure: Fibroblast growth factor
timeFrame: at enrollment
measure: Parathormone
timeFrame: at enrollment
measure: 25(OH) vitamin D
timeFrame: at enrollment
measure: Osteocalcin
timeFrame: 5 years after enrollment
measure: Procollagen type I N-terminal propeptide
timeFrame: 5 years after enrollment
measure: Bone alkaline phosphatase
timeFrame: 5 years after enrollment
measure: β-crosslaps
timeFrame: 5 years after enrollment
measure: Ca
timeFrame: 5 years after enrollment
measure: P
timeFrame: 5 years after enrollment
measure: Mg
timeFrame: 5 years after enrollment
measure: Fibroblast growth factor
timeFrame: 5 years after enrollment
measure: Parathormone
timeFrame: 5 years after enrollment
measure: 25(OH) vitamin D
timeFrame: 5 years after enrollment
measure: Gene testing(BGIseq T5,WGS)
timeFrame: at enrollment
measure: Gene testing(BGIseq T5,WGS)
timeFrame: 5 years after enrollment
Other outcomes:
Locations:
city: Gannan
country: China
facility: Nankang Traditional Chinese Medicine Hospital
state: Jiangxi
city: Yinchuan
country: China
facility: Ningxia Chinese medicine Rearch Center
state: Ningxia
city: Shanghai
country: China
facility: Longhua Hospital, Shanghai University of TCM
Study officials:
affiliation: Shanhgai University of TCM
name: Yongjun Wang
role: STUDY_CHAIR
affiliation: Ningxia Chinese medicine Rearch Center
name: Chuanglong Xu
role: STUDY_DIRECTOR
affiliation: Nankang Traditional Chinese Medicine Hospital
name: Zhangyu Liao
role: STUDY_DIRECTOR
References: