Clinical trial NCT05339425: Chinese Osteoporotic Fracture Registration Network Platform
Official title: Construction of Chinese Osteoporotic Fracture Registration Network Platform and National Cooperative Network
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoporosis
Osteoporotic Fractures
Keywords: Database
Osteoporosis
Osteoporotic Fractures
Registration
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
Collaborators: name: Xuanwu Hospital, Beijing
name: Beijing Hospital
name: Tianjin First Central Hospital
name: Hebei Medical University Third Hospital
name: The Second Affiliated Hospital of Harbin Medical University
name: Peking University Third Hospital
name: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Ruijin Hospital
name: Affiliated Hospital of Nantong University
name: Shanghai Changzheng Hospital
name: Wuhan Union Hospital, China
name: Central South University
name: Nanfang Hospital, Southern Medical University
name: The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
name: First Affiliated Hospital of Fujian Medical University
name: Second Affiliated Hospital of Guangzhou Medical University
name: The Seventh Affiliated Hospital of Sun Yat-sen University
name: Sichuan Province Orthopetic Hospital
name: The Second Affiliated Hospital of Chongqing Medical University
name: Daping Hospital, Army Medical Center of PLA
name: First Affiliated Hospital Xi'an Jiaotong University
name: The First Affiliated Hospital of Zhengzhou University
name: Second Affiliated Hospital of Soochow University
name: The First Affiliated Hospital with Nanjing Medical University
name: Peking University Shenzhen Hospital
name: General Hospital of Ningxia Medical University
name: Second Affiliated Hospital of Wenzhou Medical University
name: Beijing Jishuitan Hospital
name: Zhejiang Hospital
name: Shenzhen People's Hospital
name: Xiangya Hospital of Central South University
name: Beijing Friendship Hospital
name: Shanghai 6th People's Hospital
name: Shanghai East Hospital of Tongji University
name: Zhongda Hospital
name: First Affiliated Hospital of Jinan University
name: Fujian Provincial Hospital
First posted: 2022-04-21
Enrollment: 50000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients at high risk of fracture.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Total number of patients enrolled in 3 years
timeFrame: 3 years
measure: Age distribution
timeFrame: 3 years
measure: Sex ratio
timeFrame: 3 years
measure: Body Mass Index (BMI) of enrolled patients
timeFrame: 3 years
measure: Quality of life of enrolled patients
timeFrame: 3 years
measure: Fall risk assessment of enrolled patients
timeFrame: 3 years
measure: Fracture risk Assessment of enrolled patients
timeFrame: 3 years
measure: Bone turnover markers (BTMs)
timeFrame: 3 years
measure: Bone mineral density of enrolled patients
timeFrame: 3 years
measure: Health record analysis
timeFrame: 3 years
Secondary outcomes:
measure: Follow-up rate after enrollment
timeFrame: Every year of the 3 years
measure: Usage rate of anti-osteoporosis drugs
timeFrame: Every year of the 3 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Shijingshan Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Beijing
country: China
facility: The Second Medical Center of The General Hospital of the People's Liberation Army
state: Beijing
city: Beijing
country: China
facility: Xuanwu Hospital, Capital Medical University
state: Beijing
city: Chongqing
country: China
facility: Daping Hospital, Army Medical Center of PLA
state: Chongqing
city: Chongqing
country: China
facility: The Second Affiliated Hospital of Chongqing Medical University
state: Chongqing
city: Fuzhou
country: China
facility: Fuzhou Second Hospital
state: Fujian
city: Fuzhou
country: China
facility: The First Affiliated Hospital of Fujian Medical University
state: Fujian
city: Foshan
country: China
facility: Lunjiao Hospital of Shunde Foshan
state: Guangdong
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Nanfang Hospital, Southern Medical University
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou University of Chinese Medicine
state: Guangdong
city: Guangzhou
country: China
facility: The Second Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen Second People's Hospital
state: Guangdong
city: Shenzhen
country: China
facility: The Seventh Affiliated Hospital, Sun Yat-sen University
state: Guangdong
city: Guiyang
country: China
facility: Guizhou Provincial Orthopedics Hospital
state: Guizhou
city: Shijiazhuang
country: China
facility: The Third Hospital of Hebei Medical University
state: Hebei
city: Harbin
country: China
facility: The Second Affiliated Hospital of Harbin Medical University
state: Heilongjiang
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Wuhan
country: China
facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hunan
city: Changzhou
country: China
facility: The First People's hospital of Changzhou
state: Jiangsu
city: Nantong
country: China
facility: Affiliated Hospital of Nantong University
state: Jiangsu
city: Nantong
country: China
facility: Nantong First People's Hospital
state: Jiangsu
city: Suzhou
country: China
facility: The Second Affiliated Hospital of Soochow University
state: Jiangsu
city: Dalian
country: China
facility: Dalian Hospital of Chinese Traditional and Western Medicine
state: Liaoning
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai Jiaotong University School of Medicine
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Changzheng Hospital
state: Shanghai
city: Shanghai
country: China
facility: Tenth People's Hospital of Tongji University
state: Shanghai
city: Chendu
country: China
facility: Sichuan Province Orthopedic Hospital
state: Sichuan
city: Chendu
country: China
facility: Sichuan Provincial People's Hospital
state: Sichuan
city: Chendu
country: China
facility: West China Fourth Hospital, Sichuan University
state: Sichuan
city: Tianjin
country: China
facility: Tianjin First Central Hospital
state: Tianjin
city: Urumqi
country: China
facility: Traditional Chinese Medicine Hospital of Xinjiang Uygur Autonomous Region
state: Xinjiang
city: Hangzhou
country: China
facility: The Second Affiliated Hospital, Zhejiang University School of Medicine
state: Zhejiang
city: Ningbo
country: China
facility: Huamei Hospital, University of Chinese Academy of Sciences
state: Zhejiang
Study officials:
affiliation: Peking Union Medical College Hospital
name: Weibo Xia, MD
role: STUDY_CHAIR
References: