Senile Osteoporosis With Current Pathological Fracture Lower Leg (Diagnosis)NCT04129671
Rare Variation and Remote Gene Regulation of Osteoporosis Related Phenotypes in Han Chinesse
An observational study of Senile Osteoporosis With Current Pathological Fracture Lower Leg (Diagnosis), run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 100 years
- Conditions the study is for
- Senile Osteoporosis With Current Pathological Fracture Lower Leg (Diagnosis)
- How many people
- 3,000 participants
- Where
- 1 siteChina
- Study dates
- 29 Apr 2019to 31 Dec 2021
- 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 50 to 100 years
- All sexes
- Adult, Older adult
Study population: 1. From July 2018 to July 2021, patients admitted to the outpatient or inpatient clinic were diagnosed as primary osteoporosis fracture; 2. Aged between 50 and 100; 3. This fracture was not treated with any anti-osteoporosis drugs before
Who may be able to join
- 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
Who cannot join
- 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;
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- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Hangzhou, Zhejing Province, 310009
Zhimin Ying, Doctore, +86 0571 87783759, 11018061@zju.edu.cn
About this study
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.
Read the 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.
- Being tested
- No intervention was applied
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention was appliedGenetic
No intervention was administered
What is being measured
The primary outcome is the main question the study is designed to answer.
Exon sequencing results from the target region
Exon sequencing
Measured: June 2018-December 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2019
- Study start29 Apr 2019
- Primary completion1 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Senile Osteoporosis With Current Pathological Fracture Lower Leg (Diagnosis)Studies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- 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
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Westlake University
- Responsible party
- Principal investigator, Shigui Yan, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04129671
- Sponsor's protocol ID
- 2018-090
- Status last verified
- Oct 2019
- First submitted
- 15 Oct 2019
- Last updated
- 17 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 25784778Mendoza 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.
PubMed 22335445
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rare Variation and Remote Gene Regulation of Osteoporosis Related Phenotypes in Han Chinesse
- ClinicalTrials.gov ID
- NCT04129671
- Acronym / sponsor ID
- 2018-090
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- Westlake University
- Study start
- 29 Apr 2019 (actual)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 17 Oct 2019 (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 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.
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 design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 1. From July 2018 to July 2021, patients admitted to the outpatient or inpatient clinic were diagnosed as primary osteoporosis fracture; 2. Aged between 50 and 100; 3. This fracture was not treated with any anti-osteoporosis drugs before
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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.;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention was appliedNo intervention was administered | Genetic | – |
Primary outcome
Exon sequencing results from the target region
Time frame: June 2018-December 2021
Exon sequencing
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2019.
- Background: PubMed 25784778He 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.
- Results publication: PubMed 22335445Mendoza 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.
- Individual participant dataSharing planned: Undecided
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Senile Osteoporosis With Current Pathological Fracture Lower Leg (Diagnosis), run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site 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 5 inclusion and 9 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 17 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Shigui Yan, Doctore (057187783530, Olivery@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exon sequencing results from the target region (time frame: June 2018-December 2021). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04129671, which also lists 2 linked publications.
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 17 Oct 2019.