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.
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.
Study Type
OBSERVATIONAL
Enrollment
50,000
No additional intervention will be administered.
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Beijing Hospital
Beijing, Beijing Municipality, China
Beijing Shijingshan Hospital
Beijing, Beijing Municipality, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
The Second Medical Center of The General Hospital of the People's Liberation Army
Beijing, Beijing Municipality, China
Total number of patients enrolled in 3 years
The number of patients enrolled in Chinese Osteoporotic Fracture Registration Network Platform (CORN) in 3 years
Time frame: 3 years
Age distribution
Age distribution of enrolled patients
Time frame: 3 years
Sex ratio
Sex ratio of enrolled patients
Time frame: 3 years
Body Mass Index (BMI) of enrolled patients
Weight and height will be combined to report BMI in kg/m\^2
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 3 years
Bone turnover markers (BTMs)
BTMs of enrolled patients will be tested and analyzed.
Time frame: 3 years
Bone mineral density of enrolled patients
Bone mineral density (BMD) should be measured with dual energy X-ray absorptiometry (DXA).
Time frame: 3 years
Health record analysis
A comprehensive evaluation of patients' medical records, including symptoms, physical examination, treatments, etc.
Time frame: 3 years
Follow-up rate after enrollment
Follow-up rate after enrollment will be calculated
Time frame: Every year of the 3 years
Usage rate of anti-osteoporosis drugs
Usage rate of anti-osteoporosis drugs will be analyzed
Time frame: Every year of the 3 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Daping Hospital, Army Medical Center of PLA
Chongqing, Chongqing Municipality, China
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Fuzhou Second Hospital
Fuzhou, Fujian, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
...and 29 more locations