Construction of Chinese Osteoporotic Fracture Registration Network Platform and National Cooperative Network
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50,000
- 试验地点
- 39
- 主要终点
- Bone turnover markers (BTMs)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •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.
结局指标
主要结局
Bone turnover markers (BTMs)
时间窗: 3 years
BTMs of enrolled patients will be tested and analyzed.
Health record analysis
时间窗: 3 years
A comprehensive evaluation of patients' medical records, including symptoms, physical examination, treatments, etc.
Fracture risk Assessment of enrolled patients
时间窗: 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
时间窗: 3 years
The number of patients enrolled in Chinese Osteoporotic Fracture Registration Network Platform (CORN) in 3 years
Age distribution
时间窗: 3 years
Age distribution of enrolled patients
Body Mass Index (BMI) of enrolled patients
时间窗: 3 years
Weight and height will be combined to report BMI in kg/m\^2
Quality of life of enrolled patients
时间窗: 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
时间窗: 3 years
Bone mineral density (BMD) should be measured with dual energy X-ray absorptiometry (DXA).
Sex ratio
时间窗: 3 years
Sex ratio of enrolled patients
Fall risk assessment of enrolled patients
时间窗: 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.
次要结局
- Follow-up rate after enrollment(Every year of the 3 years)
- Usage rate of anti-osteoporosis drugs(Every year of the 3 years)