Chinese Osteoporotic Fracture Registration Network Platform

Osteoporosis Clinical Trial

— CORN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05339425
• Other study ID #: 2021YFC2501701
• Status: Recruiting
• Start date: December 1, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2022
• Source: Peking Union Medical College Hospital
• Contact: Weibo Xia, MD
• Phone: 86 13501002126 86-10-6915-5076
• Email: xiaweibo8301[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50000
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Fractures, Bone
• Osteoporosis
• Osteoporotic Fractures

Intervention

Other:
• No additional intervention will be administered.
No additional intervention will be administered.

Locations

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

Sponsors (38)

Lead Sponsor

Collaborator

Peking Union Medical College Hospital

Affiliated Hospital of Nantong University, Beijing Hospital, Beijing Shijingshan Hospital, Central South University, Dalian Hospital of Chinese Traditional and Western Medicine, Daping Hospital, Army Medical Center of PLA, First Affiliated Hospital of Fujian Medical University, First Affiliated Hospital Xi'an Jiaotong University, Fuzhou Second Hospital, Guangdong Provincial People's Hospital, Guizhou Provincial Orthopedics Hospital, Hebei Medical University Third Hospital, Huamei hospital, University of Chinese Academy of Sciences, Lunjiao Hospital of Shunde Foshan, Nanfang Hospital of Southern Medical University, Nantong First People's Hospital, Peking University Third Hospital, Ruijin Hospital, Second Affiliated Hospital of Guangzhou Medical University, Second Affiliated Hospital, School of Medicine, Zhejiang University, Shanghai 10th People's Hospital, Shanghai Changzheng Hospital, Shenzhen Second People's Hospital, Sichuan Province Orthopedic Hospital, Sichuan Provincial People's Hospital, The First Affiliated Hospital of Zhengzhou University, The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine, The First People's Hospital of Changzhou, The Second Affiliated Hospital of Chongqing Medical University, The Second Affiliated Hospital of Harbin Medical University, The Second Medical Center of The General Hospital of the People's Liberation Army, The Seventh Affiliated Hospital of Sun Yat-sen University, Tianjin First Central Hospital, Traditional Chinese Medicine Hospital of Xinjiang Uygur Autonomous Region, West China Fourth Hospital, Wuhan Union Hospital, China, Xuanwu Hospital, Beijing

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Age distribution	Age distribution of enrolled patients	3 years
Primary	Sex ratio	Sex ratio of enrolled patients	3 years
Primary	Body Mass Index (BMI) of enrolled patients	Weight and height will be combined to report BMI in kg/m^2	3 years
Primary	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
Primary	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
Primary	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
Primary	Bone turnover markers (BTMs)	BTMs of enrolled patients will be tested and analyzed.	3 years
Primary	Bone mineral density of enrolled patients	Bone mineral density (BMD) should be measured with dual energy X-ray absorptiometry (DXA).	3 years
Primary	Health record analysis	A comprehensive evaluation of patients' medical records, including symptoms, physical examination, treatments, etc.	3 years
Secondary	Follow-up rate after enrollment	Follow-up rate after enrollment will be calculated	Every year of the 3 years
Secondary	Usage rate of anti-osteoporosis drugs	Usage rate of anti-osteoporosis drugs will be analyzed	Every year of the 3 years