Chinese Osteoporotic Fracture Registration Network Platform

Construction of Chinese Osteoporotic Fracture Registration Network Platform and National Cooperative Network

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05339425

Acronym

CORN

Enrollment

50000

Registered

2022-04-21

Start date

2021-12-01

Completion date

2024-12-31

Last updated

2025-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis, Osteoporotic Fractures

Keywords

Database, Osteoporosis, Osteoporotic Fractures, Registration

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.

Interventions

OTHERNo additional intervention will be administered.

No additional intervention will be administered.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Health record analysis	3 years	A comprehensive evaluation of patients' medical records, including symptoms, physical examination, treatments, etc.
Bone turnover markers (BTMs)	3 years	BTMs of enrolled patients will be tested and analyzed.
Bone mineral density of enrolled patients	3 years	Bone mineral density (BMD) should be measured with dual energy X-ray absorptiometry (DXA).
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
Sex ratio	3 years	Sex ratio 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.
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.
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.

Secondary

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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026