- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04129671
Rare Variation and Remote Gene Regulation of Osteoporosis Related Phenotypes in Han Chinesse
October 15, 2019 updated by: Shigui Yan, Second Affiliated Hospital, School of Medicine, Zhejiang University
Bone density is recognized as the most important factor to measure osteoporosis, and the prevalence of osteoporosis increases with age.
Risk factors for osteoporosis include age, weight, exercise, diet, smoking and alcohol consumption.
What's more, osteoporosis has a strong familial aggregation, and the genetic value of bone density is between 0.6 and 0.85.
Therefore, it is necessary to conduct large-scale collection of population samples of osteoporosis fractures and relevant genetic studies.
Study Overview
Status
Unknown
Intervention / Treatment
Detailed Description
From past linkage analysis and candidate gene association studies to genome-wide association studies and second-generation sequencing technologies, researchers have found hundreds of genes and SNPs associated with bone mineral density and osteoporosis fractures.
However, current studies on osteoporosis and related phenotypes are mainly concentrated in the European and American populations, rare in Asia and other regions, and even less in the Chinese han population.
It is one of the problems to be solved in this project whether the genes and SNP loci associated with these strengths can also be applied to han Chinese population due to the existence of racial differences.
This project aims to collect the patients with primary osteoporosis and osteoporosis fracture in the Chinese han population through the orthopaedics department, and verify the identified osteoporosis susceptibility genes in the Chinese han population.
Study Type
Observational
Enrollment (Anticipated)
3000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Shigui Yan, Doctore
- Phone Number: 057187783530
- Email: Olivery@zju.edu.cn
Study Contact Backup
- Name: Zhimin Ying, Doctore
- Phone Number: 057187783533
- Email: 11018061@zju.edu.cn
Study Locations
-
-
Zhejing Province
-
Hangzhou, Zhejing Province, China, 310009
- Recruiting
- 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
-
Contact:
- Zhimin Ying, Doctore
- Phone Number: +86 0571 87783759
- Email: 11018061@zju.edu.cn
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
- From July 2018 to July 2021, patients admitted to the outpatient or inpatient clinic were diagnosed as primary osteoporosis fracture;
- Aged between 50 and 100;
- This fracture was not treated with any anti-osteoporosis drugs before
Description
Inclusion Criteria:
- From July 2018 to July 2021, patients admitted to the outpatient or inpatient clinic were diagnosed as primary osteoporosis fracture;
- Aged between 50 and 100;
- This fracture was not treated with any anti-osteoporosis drugs before
- Subjects will participate in the study voluntarily and have signed the informed consent
- Patients with clear mind and independent behavioral ability
Exclusion Criteria:
- Patients with malignant tumors are associated with bone metastases, such as lung cancer, prostate cancer, thyroid cancer, etc
- Hyperparathyroidism, Cushing syndrome, hypogonadism, hyperthyroidism, pituitary prolactinoma, diabetes
- Systemic lupus erythematosus, rheumatoid arthritis, sjogren's syndrome, dermatomyositis, mixed connective tissue disease, etc.;
- Renal osteodystrophy caused by various chronic kidney diseases;
- Gastrointestinal diseases and nutritional diseases: malabsorption syndrome, subtotal gastrectomy, chronic pancreatic diseases, chronic liver diseases, protein-calorie malnutrition, long-term intravenous nutrition support treatment, etc.;
- Leukemia, lymphoma, multiple myeloma, hyperthermia and myelodysplastic syndrome;
- Hemiplegia, paraplegia, motor dysfunction, muscular dystrophy, catalepsy and myotonic syndrome caused by various reasons;
- Glucocorticoids, immunosuppressants, heparin, anticonvulsants, anticancer drugs, aluminum-containing antacids, thyroid hormones, gnrh-a or dialysate, etc.
- Unwilling to accept dietary management or unable to sign the informed consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Ecologic or Community
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Exon sequencing results from the target region
Time Frame: June 2018-December 2021
|
Exon sequencing
|
June 2018-December 2021
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- He W, Liu M, Huang X, Qing Z, Gao W. The influence of vitamin D receptor genetic variants on bone mineral density and osteoporosis in Chinese postmenopausal women. Dis Markers. 2015;2015:760313. doi: 10.1155/2015/760313. Epub 2015 Feb 17.
- Mendoza N, Quereda F, Presa J, Salamanca A, Sanchez-Borrego R, Vazquez F, Martinez Astorquiza T. Estrogen-related genes and postmenopausal osteoporosis risk. Climacteric. 2012 Dec;15(6):587-93. doi: 10.3109/13697137.2012.656160. Epub 2012 Feb 15.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 29, 2019
Primary Completion (Anticipated)
December 1, 2021
Study Completion (Anticipated)
December 31, 2021
Study Registration Dates
First Submitted
October 15, 2019
First Submitted That Met QC Criteria
October 15, 2019
First Posted (Actual)
October 17, 2019
Study Record Updates
Last Update Posted (Actual)
October 17, 2019
Last Update Submitted That Met QC Criteria
October 15, 2019
Last Verified
October 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018-090 (Other Identifier: Akershus University Hospital Privacy Ombudsman)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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