Chinese Osteoporotic Fracture Registration Network Platform
- Conditions
- Osteoporotic FracturesOsteoporosis
- Registration Number
- NCT05339425
- Lead Sponsor
- Peking Union Medical College Hospital
- Brief 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. 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:
1. 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.
2. Clinical features: including anthropometric data, clinical symptoms, physical examination, grip strength test, balance assessment, walking speed test, etc.
3. 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).
4. 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).
5. Laboratory tests: including blood calcium and phosphorus levels, bone turnover markers, parathyroid hormone level, 25-hydroxyvitamin D, 24-hour urine calcium, etc.
6. Biological specimen collection: blood and urine specimens are plan to be obtained for further studies with informed consent.
7. Follow-ups: subjects will be followed up every 6 months for 3 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50000
Not provided
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Bone turnover markers (BTMs) 3 years BTMs of enrolled patients will be tested and analyzed.
Health record analysis 3 years A comprehensive evaluation of patients' medical records, including symptoms, physical examination, treatments, etc.
Fracture risk Assessment of enrolled patients 3 years Fracture risk will be assessed with Fracture Risk Assessment Tool (FRAX). And a higher value means a higher risk of fracture.
Total number of patients enrolled in 3 years 3 years The number of patients enrolled in Chinese Osteoporotic Fracture Registration Network Platform (CORN) in 3 years
Age distribution 3 years Age distribution of enrolled patients
Body Mass Index (BMI) of enrolled patients 3 years Weight and height will be combined to report BMI in kg/m\^2
Quality of life of enrolled patients 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.
Bone mineral density of enrolled patients 3 years Bone mineral density (BMD) should be measured with dual energy X-ray absorptiometry (DXA).
Sex ratio 3 years Sex ratio of enrolled patients
Fall risk assessment of enrolled patients 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.
- Secondary Outcome Measures
Name Time Method Follow-up rate after enrollment Every year of the 3 years Follow-up rate after enrollment will be calculated
Usage rate of anti-osteoporosis drugs Every year of the 3 years Usage rate of anti-osteoporosis drugs will be analyzed
Trial Locations
- Locations (39)
Peking Union Medical College Hospital
🇨🇳Beijing, Beijing, China
Beijing Hospital
🇨🇳Beijing, Beijing, China
Beijing Shijingshan Hospital
🇨🇳Beijing, Beijing, China
Peking University Third Hospital
🇨🇳Beijing, Beijing, China
The Second Medical Center of The General Hospital of the People's Liberation Army
🇨🇳Beijing, Beijing, China
Xuanwu Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China
Daping Hospital, Army Medical Center of PLA
🇨🇳Chongqing, Chongqing, China
The Second Affiliated Hospital of Chongqing Medical University
🇨🇳Chongqing, Chongqing, China
Fuzhou Second Hospital
🇨🇳Fuzhou, Fujian, China
The First Affiliated Hospital of Fujian Medical University
🇨🇳Fuzhou, Fujian, China
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