Family Genetic Characteristics of OsteoporosisNCT05781594
Family Cohort Study on Primary Osteoporosis
An observational study of Family Genetic Characteristics of Osteoporosis, run by Shanghai University of Traditional Chinese Medicine at 3 sites in China.
Trial summary
Bone metabolism and genetic characteristics of osteoporosis pedigree with kidney-yang deficiency Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Family Genetic Characteristics of Osteoporosis
- How many people
- 600 participants
- Where
- 3 sitesChina
- Study dates
- 1 Oct 2022to 31 Oct 2023
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: member of family
Who may be able to join
- Be able to cooperate with inspection.There is blood relationship between the members of the enrolled family.
Who cannot join
- Unable to cooperate with inspection.There is not blood relationship between the members of the enrolled family.
Trial locations and contacts
3 sites in 1 country.
China3 sites, 3 recruiting
- Recruiting
Nankang Traditional Chinese Medicine Hospital
Gannan, Jiangxi, 341000
Zhangyu Liao, 13970708594, 13970708594@163.com
- Recruiting
Longhua Hospital, Shanghai University of TCM
Shanghai
Yongjun Wang
- Recruiting
Ningxia Chinese medicine Rearch Center
Yinchuan, Ningxia, 750000
Chuanglong Xu, 17795122519, mqxcl@163.com
About this study
Official title: Family Cohort Study on Primary Osteoporosis With Kidney-yang Deficiency Syndrome
Bone metabolism and genetic characteristics of osteoporosis pedigree with kidney-yang deficiency
Read the 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.
- Keywords
- Osteoporosis families, Kidney-yang deficiency, Genetic correlation of disease, Bone density
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in bone mineral density from baseline to 5 years after enrollment
lumbar (L1-4 as well as total) and hip bone mineral density will be recorded by dual energy X-ray absorptiometry
Measured: at enrollment
changes in bone mineral density from baseline to 5 years after enrollment
lumbar (L1-4 as well as total) and hip bone mineral density will be recorded by dual energy X-ray absorptiometry
Measured: 5 years after enrollment
Physical phenotype of traditional Chinese medicine
Occurrence of kidney yang deficiency
Measured: at enrollment
Physical phenotype of traditional Chinese medicine
Occurrence of kidney yang deficiency
Measured: 5 years after enrollment
Understand the general situation through the questionnaire
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
Measured: at enrollment
Understand the general situation through the questionnaire
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
Measured: 5 years after enrollment
Secondary outcomes (22)
Osteocalcin
serum osteocalcin
Measured: at enrollment
procollagen type I N-terminal propeptide
serum procollagen type I N-terminal propeptide (PINP)
Measured: at enrollment
Bone alkaline phosphatase
serum bone alkaline phosphatase (BALP)
Measured: at enrollment
β-crosslaps
serum β-crosslaps (β-CTX)
Measured: at enrollment
Ca
serum Ca
Measured: at enrollment
P
serum P
Measured: at enrollment
Mg
serum Mg
Measured: at enrollment
Fibroblast growth factor
serum fibroblast growth factor (FGF)23
Measured: at enrollment
Parathormone
serum parathormone (PTH)
Measured: at enrollment
25(OH) vitamin D
serum total 25(OH) vitamin D
Measured: at enrollment
Osteocalcin
serum osteocalcin
Measured: 5 years after enrollment
Procollagen type I N-terminal propeptide
serum procollagen type I N-terminal propeptide (PINP)
Measured: 5 years after enrollment
Bone alkaline phosphatase
serum bone alkaline phosphatase (BALP)
Measured: 5 years after enrollment
β-crosslaps
serum β-crosslaps (β-CTX)
Measured: 5 years after enrollment
Ca
serum Ca
Measured: 5 years after enrollment
P
serum P
Measured: 5 years after enrollment
Mg
serum Mg
Measured: 5 years after enrollment
Fibroblast growth factor
serum fibroblast growth factor (FGF)23
Measured: 5 years after enrollment
Parathormone
serum parathormone (PTH)
Measured: 5 years after enrollment
25(OH) vitamin D
serum total 25(OH) vitamin D
Measured: 5 years after enrollment
Gene testing(BGIseq T5,WGS)
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
Measured: at enrollment
Gene testing(BGIseq T5,WGS)
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
Measured: 5 years after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2023
- Study start1 Oct 2022
- Primary completion1 Sep 2023 (estimated)
- Study completion31 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Family Genetic Characteristics of OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Shanghai University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yongjun Wang, Study chair, Shanhgai University of TCMChuanglong Xu, Study director, Ningxia Chinese medicine Rearch CenterZhangyu Liao, Study director, Nankang Traditional Chinese Medicine Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05781594
- Sponsor's protocol ID
- ShanghaiUTCM20230201
- Status last verified
- Feb 2023
- First submitted
- 5 Feb 2023
- Last updated
- 23 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family Cohort Study on Primary Osteoporosis With Kidney-yang Deficiency Syndrome
- ClinicalTrials.gov ID
- NCT05781594
- Acronym / sponsor ID
- ShanghaiUTCM20230201
- Keywords
- Osteoporosis families, Kidney-yang deficiency, Genetic correlation of disease, Bone density
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Shanghai University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 31 Oct 2023 (estimated)
- First posted
- 23 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- member of family
Key inclusion criteria (1 listed)
- Be able to cooperate with inspection.There is blood relationship between the members of the enrolled family.
Key exclusion criteria (1 listed)
- Unable to cooperate with inspection.There is not blood relationship between the members of the enrolled family.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
changes in bone mineral density from baseline to 5 years after enrollment
Time frame: at enrollment
lumbar (L1-4 as well as total) and hip bone mineral density will be recorded by dual energy X-ray absorptiometry
changes in bone mineral density from baseline to 5 years after enrollment
Time frame: 5 years after enrollment
lumbar (L1-4 as well as total) and hip bone mineral density will be recorded by dual energy X-ray absorptiometry
Physical phenotype of traditional Chinese medicine
Time frame: at enrollment
Occurrence of kidney yang deficiency
Physical phenotype of traditional Chinese medicine
Time frame: 5 years after enrollment
Occurrence of kidney yang deficiency
Understand the general situation through the questionnaire
Time frame: at enrollment
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
Understand the general situation through the questionnaire
Time frame: 5 years after enrollment
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
22 secondary outcomes
Osteocalcin
Time frame: at enrollment
procollagen type I N-terminal propeptide
Time frame: at enrollment
Bone alkaline phosphatase
Time frame: at enrollment
β-crosslaps
Time frame: at enrollment
Ca
Time frame: at enrollment
P
Time frame: at enrollment
Mg
Time frame: at enrollment
Fibroblast growth factor
Time frame: at enrollment
Parathormone
Time frame: at enrollment
25(OH) vitamin D
Time frame: at enrollment
Osteocalcin
Time frame: 5 years after enrollment
Procollagen type I N-terminal propeptide
Time frame: 5 years after enrollment
Bone alkaline phosphatase
Time frame: 5 years after enrollment
β-crosslaps
Time frame: 5 years after enrollment
Ca
Time frame: 5 years after enrollment
P
Time frame: 5 years after enrollment
Mg
Time frame: 5 years after enrollment
Fibroblast growth factor
Time frame: 5 years after enrollment
Parathormone
Time frame: 5 years after enrollment
25(OH) vitamin D
Time frame: 5 years after enrollment
Gene testing(BGIseq T5,WGS)
Time frame: at enrollment
Gene testing(BGIseq T5,WGS)
Time frame: 5 years after enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2023.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yongjun Wang study chair
Shanhgai University of TCM
Chuanglong Xu study director
Ningxia Chinese medicine Rearch Center
Zhangyu Liao study director
Nankang Traditional Chinese Medicine Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Family Genetic Characteristics of Osteoporosis, run by Shanghai University of Traditional Chinese Medicine at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yongjun Wang (86-21-64385700 ext. 9903, yjwang88@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in bone mineral density from baseline to 5 years after enrollment (time frame: at enrollment). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2023.