OsteoporosisCORNNCT05339425
Chinese Osteoporotic Fracture Registration Network Platform
An observational study of Osteoporosis and Osteoporotic Fractures, run by Peking Union Medical College Hospital at 39 sites in China.
Trial summary
China has gradually entered an aging society, and the incidence of osteoporotic fractures is increasing rapidly. Although the harm of osteoporotic fracture is huge, its diagnostic rate in China is still low. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteoporosis, Osteoporotic Fractures
- What is being tested?
- No additional intervention will be administered.
- How many people
- 50,000 participants
- Where
- 39 sitesChina
- Study dates
- 1 Dec 2021to 31 Dec 2024
- How long will I take part?
- 3 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients at high risk of fracture.
Who may be able to join
- Patients with hip osteoporotic fracture.
- Patients with vertebral osteoporotic fracture.
- Patients with low T-score ( ≤ -2.5) and at least one risk factor (e.g., history of osteoporotic fractures in other sites, a parental history of hip fracture, age ≥ 65 years, BMI < 18.5kg/m2, current smoking).
- Patients with very low T-score (< -3.0).
- The ten year probability of fracture by FRAX: major osteoporosis fracture ≥20%, or hip fracture ≥3%.
Who cannot join
- Patients who are unwilling to participate in the trial, have poor compliance and do not sign informed consent.
- Patients judged as unqualified participants by clinicians.
Trial locations and contacts
39 sites in 1 country.
39 sites in 1 country
China39 sites
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Beijing Hospital
Beijing, Beijing Municipality
Beijing Shijingshan Hospital
Beijing, Beijing Municipality
Peking University Third Hospital
Beijing, Beijing Municipality
The Second Medical Center of The General Hospital of the People's Liberation Army
Beijing, Beijing Municipality
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality
The Second Xiangya Hospital of Central South University
Changsha, Hunan
The First People's hospital of Changzhou
Changzhou, Jiangsu
Sichuan Province Orthopedic Hospital
Chengdu, Sichuan
Sichuan Provincial People's Hospital
Chengdu, Sichuan
West China Fourth Hospital, Sichuan University
Chengdu, Sichuan
Daping Hospital, Army Medical Center of PLA
Chongqing, Chongqing Municipality
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality
Dalian Hospital of Chinese Traditional and Western Medicine
Dalian, Liaoning
Lunjiao Hospital of Shunde Foshan
Foshan, Guangdong
Fuzhou Second Hospital
Fuzhou, Fujian
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian
Guangdong Provincial People's Hospital
Guangzhou, Guangdong
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong
The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Guangzhou, Guangdong
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong
Guizhou Provincial Orthopedics Hospital
Guiyang, Guizhou
The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang
Affiliated Hospital of Nantong University
Nantong, Jiangsu
Nantong First People's Hospital
Nantong, Jiangsu
Huamei Hospital, University of Chinese Academy of Sciences
Ningbo, Zhejiang
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality
Tenth People's Hospital of Tongji University
Shanghai, Shanghai Municipality
Shenzhen Second People's Hospital
Shenzhen, Guangdong
The Seventh Affiliated Hospital, Sun Yat-sen University
Shenzhen, Guangdong
The Third Hospital of Hebei Medical University
Shijiazhuang, Hebei
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215000
Tianjin First Central Hospital
Tianjin, Tianjin Municipality
Traditional Chinese Medicine Hospital of Xinjiang Uygur Autonomous Region
Ürümqi, Xinjiang
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
About this study
Official title: Construction of Chinese Osteoporotic Fracture Registration Network Platform and National Cooperative Network
China has gradually entered an aging society, and the incidence of osteoporotic fractures is increasing rapidly. Although the harm of osteoporotic fracture is huge, its diagnostic rate in China is still low. China still lacks a national osteoporotic fracture registration system, which has been established in many countries. The purpose of this study is to establish a Chinese osteoporotic fracture registration network platform (CORN), which will be helpful for the long-term comprehensive management of osteoporotic fracture population in China. This platform will help to establish a large prospective clinical cohort database of osteoporotic fractures and high-risk population in China.
Read the detailed description
Previous studies have shown that the screening, diagnosis and treatment rates of osteoporosis and osteoporotic fracture in China are still low. The goal of this study is to establish a nationwide multicenter osteoporotic fracture registration network platform, a national collaborative network, a large osteoporotic fracture research cohort and a national biological specimen bank in Chinese mainland.
About 100 hospitals covering 20 provinces, autonomous regions and municipalities will be selected as collaborators. Each collaborator is going to enroll at least 500 patients with osteoporotic fractures on average, and a total of 50000 subjects are planned to be enrolled in our study.
Subjects will be assessed as follows:
- Questionnaire investigation: including demographic data, past medical history, reproductive history, menstrual/menopausal history, family history of osteoporosis and fractures, awareness of disease, diagnosis and treatment of osteoporotic fractures, etc.
- Clinical features: including anthropometric data, clinical symptoms, physical examination, grip strength test, balance assessment, walking speed test, etc.
- Fall risk assessment: assessed by the Short Physical Performance Battery (SPPB), the Falls Risk for Older People in the Community (FROP-Com) and Morse Fall Scale (MFS).
- Imaging evaluation: including thoracolumbar spine x-ray, bone mineral density (BMD) measurement by dual-energy x-ray absorptiometry (DXA), Quantitative computed tomography (QCT) and high-resolution peripheral quantitative computed tomography (HR-pQCT).
- Laboratory tests: including blood calcium and phosphorus levels, bone turnover markers, parathyroid hormone level, 25-hydroxyvitamin D, 24-hour urine calcium, etc.
- Biological specimen collection: blood and urine specimens are plan to be obtained for further studies with informed consent.
- Follow-ups: subjects will be followed up every 6 months for 3 years.
- Conditions
- Osteoporosis, Osteoporotic Fractures
- Being tested
- No additional intervention will be administered.
- Keywords
- Database, Osteoporosis, Osteoporotic Fractures, Registration
- Medical subject headings
- Osteoporosis, Osteoporotic Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No additional intervention will be administered.Other
No additional intervention will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Osteoporotic fracture | No additional intervention will be administered. Receives: Other: No additional intervention will be administered. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total number of patients enrolled in 3 years
The number of patients enrolled in Chinese Osteoporotic Fracture Registration Network Platform (CORN) in 3 years
Measured: 3 years
Age distribution
Age distribution of enrolled patients
Measured: 3 years
Sex ratio
Sex ratio of enrolled patients
Measured: 3 years
Body Mass Index (BMI) of enrolled patients
Weight and height will be combined to report BMI in kg/m^2
Measured: 3 years
Quality of life of enrolled patients
Quality of life will be assessed with a five-level EuroQol five-dimensional (EQ-5D-5L) questionnaire (Chinese version). Measurement results of EQ-5D-5L will be used to generate values with an EQ-5D-5L Value Set for China. And a higher value means a better QOL.
Measured: 3 years
Fall risk assessment of enrolled patients
Fall risk will be assessed with Morse Fall Scale (Chinese version). The minimum value is 0, and the maximum value is 125. A higher value means a higher risk of fall.
Measured: 3 years
Fracture risk Assessment of enrolled patients
Fracture risk will be assessed with Fracture Risk Assessment Tool (FRAX). And a higher value means a higher risk of fracture.
Measured: 3 years
Bone turnover markers (BTMs)
BTMs of enrolled patients will be tested and analyzed.
Measured: 3 years
Bone mineral density of enrolled patients
Bone mineral density (BMD) should be measured with dual energy X-ray absorptiometry (DXA).
Measured: 3 years
Health record analysis
A comprehensive evaluation of patients' medical records, including symptoms, physical examination, treatments, etc.
Measured: 3 years
Secondary outcomes (2)
Follow-up rate after enrollment
Follow-up rate after enrollment will be calculated
Measured: Every year of the 3 years
Usage rate of anti-osteoporosis drugs
Usage rate of anti-osteoporosis drugs will be analyzed
Measured: Every year of the 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2022
- Study start1 Dec 2021
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50,000 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Xuanwu Hospital, Beijing, Beijing Hospital, Tianjin First Central Hospital, Hebei Medical University Third Hospital, The Second Affiliated Hospital of Harbin Medical University, Peking University Third Hospital, Second Affiliated Hospital, Zhejiang University, School of Medicine, Ruijin Hospital, Affiliated Hospital of Nantong University, Shanghai Changzheng Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Second Xiangya Hospital of Central South University, Nanfang Hospital, Southern Medical University, The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine, First Affiliated Hospital of Fujian Medical University, Second Affiliated Hospital of Guangzhou Medical University, The Seventh Affiliated Hospital of Sun Yat-sen University, Sichuan Province Orthopetic Hospital, The Second Affiliated Hospital of Chongqing Medical University, Daping Hospital, Army Medical Center of PLA, First Affiliated Hospital Xi'an Jiaotong University, The First Affiliated Hospital of Zhengzhou University, Second Affiliated Hospital of Soochow University, The First Affiliated Hospital with Nanjing Medical University, Peking University Shenzhen Hospital, General Hospital of Ningxia Medical University, Second Affiliated Hospital of Wenzhou Medical University, Beijing Jishuitan Hospital, Zhejiang Hospital, Shenzhen People's Hospital, Xiangya Hospital of Central South University, Beijing Friendship Hospital, Shanghai 6th People's Hospital, Shanghai East Hospital of Tongji University, Zhongda Hospital, First Affiliated Hospital of Jinan University, Fujian Provincial Hospital
- Responsible party
- Sponsor
- Investigators
- Weibo Xia, MD, Study chair, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05339425
- Sponsor's protocol ID
- 2021YFC2501701
- Acronym
- CORN
- Status last verified
- Mar 2024
- First submitted
- 1 Apr 2022
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction of Chinese Osteoporotic Fracture Registration Network Platform and National Cooperative Network
- ClinicalTrials.gov ID
- NCT05339425
- Acronym / sponsor ID
- CORN / 2021YFC2501701
- Conditions
- Osteoporosis, Osteoporotic Fractures
- Keywords
- Database, Osteoporosis, Osteoporotic Fractures, Registration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50,000 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- Xuanwu Hospital, Beijing, Beijing Hospital, Tianjin First Central Hospital, Hebei Medical University Third Hospital, The Second Affiliated Hospital of Harbin Medical University, Peking University Third Hospital, Second Affiliated Hospital, Zhejiang University, School of Medicine, Ruijin Hospital, Affiliated Hospital of Nantong University, Shanghai Changzheng Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Second Xiangya Hospital of Central South University, Nanfang Hospital, Southern Medical University, The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine, First Affiliated Hospital of Fujian Medical University, Second Affiliated Hospital of Guangzhou Medical University, The Seventh Affiliated Hospital of Sun Yat-sen University, Sichuan Province Orthopetic Hospital, The Second Affiliated Hospital of Chongqing Medical University, Daping Hospital, Army Medical Center of PLA, First Affiliated Hospital Xi'an Jiaotong University, The First Affiliated Hospital of Zhengzhou University, Second Affiliated Hospital of Soochow University, The First Affiliated Hospital with Nanjing Medical University, Peking University Shenzhen Hospital, General Hospital of Ningxia Medical University, Second Affiliated Hospital of Wenzhou Medical University, Beijing Jishuitan Hospital, Zhejiang Hospital, Shenzhen People's Hospital, Xiangya Hospital of Central South University, Beijing Friendship Hospital, Shanghai 6th People's Hospital, Shanghai East Hospital of Tongji University, Zhongda Hospital, First Affiliated Hospital of Jinan University, Fujian Provincial Hospital
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 21 Apr 2022 (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.
China has gradually entered an aging society, and the incidence of osteoporotic fractures is increasing rapidly. Although the harm of osteoporotic fracture is huge, its diagnostic rate in China is still low. China still lacks a national osteoporotic fracture registration system, which has been established in many countries. The purpose of this study is to establish a Chinese osteoporotic fracture registration network platform (CORN), which will be helpful for the long-term comprehensive management of osteoporotic fracture population in China. This platform will help to establish a large prospective clinical cohort database of osteoporotic fractures and high-risk population in China.
Detailed description
Previous studies have shown that the screening, diagnosis and treatment rates of osteoporosis and osteoporotic fracture in China are still low. The goal of this study is to establish a nationwide multicenter osteoporotic fracture registration network platform, a national collaborative network, a large osteoporotic fracture research cohort and a national biological specimen bank in Chinese mainland.
About 100 hospitals covering 20 provinces, autonomous regions and municipalities will be selected as collaborators. Each collaborator is going to enroll at least 500 patients with osteoporotic fractures on average, and a total of 50000 subjects are planned to be enrolled in our study.
Subjects will be assessed as follows:
- Questionnaire investigation: including demographic data, past medical history, reproductive history, menstrual/menopausal history, family history of osteoporosis and fractures, awareness of disease, diagnosis and treatment of osteoporotic fractures, etc.
- Clinical features: including anthropometric data, clinical symptoms, physical examination, grip strength test, balance assessment, walking speed test, etc.
- Fall risk assessment: assessed by the Short Physical Performance Battery (SPPB), the Falls Risk for Older People in the Community (FROP-Com) and Morse Fall Scale (MFS).
- Imaging evaluation: including thoracolumbar spine x-ray, bone mineral density (BMD) measurement by dual-energy x-ray absorptiometry (DXA), Quantitative computed tomography (QCT) and high-resolution peripheral quantitative computed tomography (HR-pQCT).
- Laboratory tests: including blood calcium and phosphorus levels, bone turnover markers, parathyroid hormone level, 25-hydroxyvitamin D, 24-hour urine calcium, etc.
- Biological specimen collection: blood and urine specimens are plan to be obtained for further studies with informed consent.
- Follow-ups: subjects will be followed up every 6 months for 3 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Osteoporotic fracture | – | Other: No additional intervention will be administered.No additional intervention will be administered. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients at high risk of fracture.
Key inclusion criteria (5 listed)
- Patients with hip osteoporotic fracture.
- Patients with vertebral osteoporotic fracture.
- Patients with low T-score ( ≤ -2.5) and at least one risk factor (e.g., history of osteoporotic fractures in other sites, a parental history of hip fracture, age ≥ 65 years, BMI < 18.5kg/m2, current smoking).
- Patients with very low T-score (< -3.0).
- The ten year probability of fracture by FRAX: major osteoporosis fracture ≥20%, or hip fracture ≥3%.
Key exclusion criteria (2 listed)
- Patients who are unwilling to participate in the trial, have poor compliance and do not sign informed consent.
- Patients judged as unqualified participants by clinicians.
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 additional intervention will be administered.No additional intervention will be administered. | Other | Osteoporotic fracture |
Primary outcome
Total number of patients enrolled in 3 years
Time frame: 3 years
The number of patients enrolled in Chinese Osteoporotic Fracture Registration Network Platform (CORN) in 3 years
Age distribution
Time frame: 3 years
Age distribution of enrolled patients
Sex ratio
Time frame: 3 years
Sex ratio of enrolled patients
Body Mass Index (BMI) of enrolled patients
Time frame: 3 years
Weight and height will be combined to report BMI in kg/m^2
Quality of life of enrolled patients
Time frame: 3 years
Quality of life will be assessed with a five-level EuroQol five-dimensional (EQ-5D-5L) questionnaire (Chinese version). Measurement results of EQ-5D-5L will be used to generate values with an EQ-5D-5L Value Set for China. And a higher value means a better QOL.
Fall risk assessment of enrolled patients
Time frame: 3 years
Fall risk will be assessed with Morse Fall Scale (Chinese version). The minimum value is 0, and the maximum value is 125. A higher value means a higher risk of fall.
Fracture risk Assessment of enrolled patients
Time frame: 3 years
Fracture risk will be assessed with Fracture Risk Assessment Tool (FRAX). And a higher value means a higher risk of fracture.
Bone turnover markers (BTMs)
Time frame: 3 years
BTMs of enrolled patients will be tested and analyzed.
Bone mineral density of enrolled patients
Time frame: 3 years
Bone mineral density (BMD) should be measured with dual energy X-ray absorptiometry (DXA).
Health record analysis
Time frame: 3 years
A comprehensive evaluation of patients' medical records, including symptoms, physical examination, treatments, etc.
2 secondary outcomes
Follow-up rate after enrollment
Time frame: Every year of the 3 years
Usage rate of anti-osteoporosis drugs
Time frame: Every year of the 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
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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.
Weibo Xia, MD study chair
Peking Union Medical College Hospital
39 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoporosis and Osteoporotic Fractures, run by Peking Union Medical College Hospital at 39 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 5 inclusion and 2 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: finished, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total number of patients enrolled in 3 years (time frame: 3 years). The study lists 10 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 25 Feb 2025.