Chinese Osteoporotic Fracture Registration Network Platform (CORN)

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.

Study Overview

• Status: Completed
• Conditions: Osteoporosis; Osteoporotic Fractures
• Intervention / Treatment: Other: No additional intervention will be administered.

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.

• Study Type: Observational
• Enrollment (Actual): 50000

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Peking Union Medical College Hospital
    • Beijing, Beijing, China
      • Peking University Third Hospital
    • Beijing, Beijing, China
      • Beijing Hospital
    • Beijing, Beijing, China
      • Xuanwu Hospital, Capital Medical University
    • Beijing, Beijing, China
      • Beijing Shijingshan Hospital
    • Beijing, Beijing, China
      • The Second Medical Center of The General Hospital of the People's Liberation Army
  • Chongqing
    • Chongqing, Chongqing, China
      • The Second Affiliated Hospital of Chongqing Medical University
    • Chongqing, Chongqing, China
      • Daping Hospital, Army Medical Center of PLA
  • Fujian
    • Fuzhou, Fujian, China
      • The First Affiliated Hospital of Fujian Medical University
    • Fuzhou, Fujian, China
      • Fuzhou Second Hospital
  • Guangdong
    • Foshan, Guangdong, China
      • Lunjiao Hospital of Shunde Foshan
    • Guangzhou, Guangdong, China
      • The second Affiliated Hospital of Guangzhou Medical University
    • Guangzhou, Guangdong, China
      • Nanfang Hospital, Southern Medical University
    • Guangzhou, Guangdong, China
      • Guangdong Provincial People's Hospital
    • Guangzhou, Guangdong, China
      • The First Affiliated Hospital of Guangzhou University of Chinese Medicine
    • Shenzhen, Guangdong, China
      • Shenzhen Second People's Hospital
    • Shenzhen, Guangdong, China
      • The Seventh Affiliated Hospital, Sun Yat-sen University
  • Guizhou
    • Guiyang, Guizhou, China
      • Guizhou Provincial Orthopedics Hospital
  • Hebei
    • Shijiazhuang, Hebei, China
      • The Third Hospital of Hebei Medical University
  • Heilongjiang
    • Harbin, Heilongjiang, China
      • The Second Affiliated Hospital of Harbin Medical University
  • Henan
    • Zhengzhou, Henan, China
      • the First Affiliated Hospital of Zhengzhou University
  • Hubei
    • Wuhan, Hubei, China
      • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
  • Hunan
    • Changsha, Hunan, China
      • The Second Xiangya Hospital of Central South University
  • Jiangsu
    • Changzhou, Jiangsu, China
      • The First People's Hospital of Changzhou
    • Nantong, Jiangsu, China
      • Affiliated Hospital of Nantong University
    • Nantong, Jiangsu, China
      • Nantong First People's Hospital
    • Suzhou, Jiangsu, China, 215000
      • The Second Affiliated Hospital of Soochow University
  • Liaoning
    • Dalian, Liaoning, China
      • Dalian Hospital of Chinese Traditional and Western Medicine
  • Shaanxi
    • Xi'an, Shaanxi, China
      • The First Affiliated Hospital Of Xi'an Jiaotong University
  • Shanghai
    • Shanghai, Shanghai, China
      • Shanghai Changzheng Hospital
    • Shanghai, Shanghai, China
      • Ruijin Hospital, Shanghai Jiaotong University School of Medicine
    • Shanghai, Shanghai, China
      • Tenth People's Hospital Of Tongji University
  • Sichuan
    • Chendu, Sichuan, China
      • Sichuan Provincial People's Hospital
    • Chendu, Sichuan, China
      • Sichuan Province Orthopedic Hospital
    • Chendu, Sichuan, China
      • West China Fourth Hospital, Sichuan University
  • Tianjin
    • Tianjin, Tianjin, China
      • Tianjin First Central Hospital
  • Xinjiang
    • Urumqi, Xinjiang, China
      • Traditional Chinese Medicine Hospital of Xinjiang Uygur Autonomous Region
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • The Second Affiliated Hospital, Zhejiang University School of Medicine
    • Ningbo, Zhejiang, China
      • Huamei Hospital, University of Chinese Academy of Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients at high risk of fracture.

Description

Inclusion Criteria (any of the following):

• 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%.

Exclusion Criteria:

• 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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Osteoporotic fracture; No additional intervention will be administered.	Other: No additional intervention will be administered.; No additional intervention will be administered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total number of patients enrolled in 3 years	The number of patients enrolled in Chinese Osteoporotic Fracture Registration Network Platform (CORN) in 3 years	3 years
Age distribution	Age distribution of enrolled patients	3 years
Sex ratio	Sex ratio of enrolled patients	3 years
Body Mass Index (BMI) of enrolled patients	Weight and height will be combined to report BMI in kg/m^2	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.	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.	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.	3 years
Bone turnover markers (BTMs)	BTMs of enrolled patients will be tested and analyzed.	3 years
Bone mineral density of enrolled patients	Bone mineral density (BMD) should be measured with dual energy X-ray absorptiometry (DXA).	3 years
Health record analysis	A comprehensive evaluation of patients' medical records, including symptoms, physical examination, treatments, etc.	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Follow-up rate after enrollment	Follow-up rate after enrollment will be calculated	Every year of the 3 years
Usage rate of anti-osteoporosis drugs	Usage rate of anti-osteoporosis drugs will be analyzed	Every year of the 3 years

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Collaborators: The First Affiliated Hospital with Nanjing Medical University; Xiangya Hospital of Central South University; Beijing Friendship Hospital; Peking University Third Hospital; Second Affiliated Hospital, School of Medicine, Zhejiang University; First Affiliated Hospital of Fujian Medical University; First Affiliated Hospital Xi'an Jiaotong University; Xuanwu Hospital, Beijing; Ruijin Hospital; Beijing Hospital; The First Affiliated Hospital of Zhengzhou University; Shenzhen People's Hospital; Wuhan Union Hospital, China; First Affiliated Hospital of Jinan University; Second Affiliated Hospital of Wenzhou Medical University; Zhongda Hospital; Central South University; The Second Affiliated Hospital of Chongqing Medical University; Peking University Shenzhen Hospital; General Hospital of Ningxia Medical University; Second Affiliated Hospital of Soochow University; Tianjin First Central Hospital; The Second Affiliated Hospital of Harbin Medical University; Shanghai Changzheng Hospital; Second Affiliated Hospital of Guangzhou Medical University; The Seventh Affiliated Hospital of Sun Yat-sen University; Hebei Medical University Third Hospital; Beijing Jishuitan Hospital; Fujian Provincial Hospital; Shanghai 6th People's Hospital; The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine; Affiliated Hospital of Nantong University; Sichuan Province Orthopetic Hospital; Daping Hospital, Army Medical Center of PLA; Zhejiang Hospital; Shanghai East Hospital of Tongji University; Nanfang Hospital, Southern Medical University
• Investigators: Study Chair: Weibo Xia, MD, Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Actual): December 31, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: April 1, 2022
• First Submitted That Met QC Criteria: April 14, 2022
• First Posted (Actual): April 21, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 23, 2025
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Osteoporosis; Database; Osteoporotic Fractures; Registration
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Wounds and Injuries; Metabolic Diseases; Bone Diseases, Metabolic; Fractures, Bone; Osteoporosis; Osteoporotic Fractures
• Other Study ID Numbers: 2021YFC2501701

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No