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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

50,000

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Dec 2021

Typical duration for all trials

Geographic Reach

1 country

39 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3.1 years study duration

Study Start

First participant enrolled

December 1, 2021

Completed

4 months until next milestone

First Submitted

Initial submission to the registry

April 1, 2022

Completed

20 days until next milestone

First Posted

Study publicly available on registry

April 21, 2022

Completed

2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed

Last Updated

February 25, 2025

Status Verified

March 1, 2024

Enrollment Period

3.1 years

First QC Date

April 1, 2022

Last Update Submit

February 23, 2025

Conditions

Osteoporosis Osteoporotic Fractures

Keywords

DatabaseOsteoporosisOsteoporotic FracturesRegistration

Outcome Measures

Primary Outcomes (10)

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 Outcomes (2)

Follow-up rate after enrollment
Every year of the 3 years
Usage rate of anti-osteoporosis drugs
Every year of the 3 years

Study Arms (1)

Osteoporotic fracture

No additional intervention will be administered.

Other: No additional intervention will be administered.

Interventions

No additional intervention will be administered.OTHER

No additional intervention will be administered.

Osteoporotic fracture

Eligibility Criteria

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Patients at high risk of fracture.

You may qualify if:

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%.

You may not qualify if:

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Peking Union Medical College Hospitallead
Xuanwu Hospital, Beijingcollaborator
Beijing Hospitalcollaborator
Tianjin First Central Hospitalcollaborator
Hebei Medical University Third Hospitalcollaborator
The Second Affiliated Hospital of Harbin Medical Universitycollaborator
Peking University Third Hospitalcollaborator
Second Affiliated Hospital, School of Medicine, Zhejiang Universitycollaborator
Ruijin Hospitalcollaborator
Affiliated Hospital of Nantong Universitycollaborator
Shanghai Changzheng Hospitalcollaborator
Union Hospital, Tongji Medical College, Huazhong University of Science and Technologycollaborator
Second Xiangya Hospital of Central South Universitycollaborator
Nanfang Hospital, Southern Medical Universitycollaborator
The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicinecollaborator
First Affiliated Hospital of Fujian Medical Universitycollaborator
Second Affiliated Hospital of Guangzhou Medical Universitycollaborator
The Seventh Affiliated Hospital of Sun Yat-sen Universitycollaborator
Sichuan Province Orthopetic Hospitalcollaborator
The Second Affiliated Hospital of Chongqing Medical Universitycollaborator
Daping Hospital, Army Medical Center of PLAcollaborator
First Affiliated Hospital Xi'an Jiaotong Universitycollaborator
The First Affiliated Hospital of Zhengzhou Universitycollaborator
Second Affiliated Hospital of Soochow Universitycollaborator
The First Affiliated Hospital with Nanjing Medical Universitycollaborator
Peking University Shenzhen Hospitalcollaborator
General Hospital of Ningxia Medical Universitycollaborator
Second Affiliated Hospital of Wenzhou Medical Universitycollaborator
Beijing Jishuitan Hospitalcollaborator
Zhejiang Hospitalcollaborator
Shenzhen People's Hospitalcollaborator
Xiangya Hospital of Central South Universitycollaborator
Beijing Friendship Hospitalcollaborator
Shanghai 6th People's Hospitalcollaborator
Shanghai East Hospital of Tongji Universitycollaborator
Zhongda Hospitalcollaborator
First Affiliated Hospital of Jinan Universitycollaborator
Fujian Provincial Hospitalcollaborator

Study Sites (39)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

Beijing Hospital