A Tiered Management System of Osteoporosis in China

Osteoporosis Clinical Trial

Official title:

Establishing A National Tiered Diagnosis and Treatment System of Osteoporosis in China: A Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03916289
• Other study ID #: JS-1894
• Status: Recruiting
• Start date: November 1, 2018
• Est. completion date: September 30, 2021

Study information

• Verified date: April 2019
• Source: Peking Union Medical College Hospital
• Contact: Weibo Xia, MD
• Phone: +86 69151552
• Email: xiaweibo8301[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

There is a management gap in China. This study aims to establish a tiered management system of osteoporosis for Chinese patients. Including:

1. Developing a national hierarchical health management network platform for middle-aged and elderly osteoporosis patients. With this platform, the data of medical records, laboratory results would be shared between medical institutions. And primary hospitals can refer the patients to the nearest medical centre for advanced auxiliary examinations and diagnosis.

2. Establishing a muti-level hospital collaboration, doctor-patient interaction management model of osteoporosis.

3. To explore and establish a early warning and screening pathways for osteoporosis.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15000
• Est. completion date: September 30, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Postmenopausal women or men aged 50 years or older

Conform to the diagnosis of osteoporosis or osteopenia as followings:

1. Bone mineral density measured by dual-energy X-ray absorptiometry show a T-score = -1.0 at neck of femur or total hip or lumber 1-4 OR

2. Have at least once major osteoporotic fracture

Exclusion Criteria:

• Screened people who do not meet the inclusion criteria

Related Conditions & MeSH terms

• Bone Diseases, Metabolic
• Osteopenia
• Osteoporosis

Intervention

Other:
• No intervention would be taken
No intervention would be taken. Patients enrolled would be managed by this tiered diagnosis and treatment system and receive standard treatment according to clinical guidelines of osteoporosis.

Locations

Country	Name	City	State
China	Beijing Friendship Hospital	Beijing	Beijing
China	Beijing Jishuitan Hospital	Beijing	Beijing
China	Beijing shijingshan hospital	Beijing	Beijing
China	Chinese PLA General Hospital	Beijing	Beijing
China	Peking Union Medical College Hospital	Beijing	Beijing
China	Peking University Third Hospital	Beijing	Beijing
China	The fourth hospital of jilin university	Changchun	Jilin
China	The Second Hospital of Xiangya,Central South University	Changsha	Hunan
China	West China hospital of sichuan university	Chengdu	Sichuan
China	Western theater general hospital	Chengdu	Sichuan
China	Fujian Provincial Hospital	Fuzhou	Fujian
China	Guangdong Provincial People's Hospital	Guangzhou	Guangdong
China	Jiangxi Provincial People's Hospital	Nanchang	Jiangxi
China	Nanjing Drum Tower Hospital	Nanjing	Jiangsu
China	Huadong hospital affiliated to fudan university	Shanghai	Shanghai
China	Shanghai first people's hospital affiliated to Shanghai jiaotong university	Shanghai	Shanghai
China	The Sixth People's Hospital Affiliated to Shanghai Jiaotong University	Shanghai	Shanghai
China	Tongji hospital affiliated to tongji university	Shanghai	Shanghai
China	Shengjing hospital affiliated to China medical university	Shenyang	Liaoning
China	The third hospital of hebei medical university	Shijiazhuang	Hebei
China	The Second Affiliated Hospital of Soochow University	Suzhou	Jiangsu
China	The first affiliated hospital of shanxi medical university	Taiyuan	Shanxi
China	Tianjin hospital	Tianjin	Tianjin
China	Xi'an Red Cross hospital	Xi'an	Shannxi
China	People's hospital of ningxia hui autonomous region	Yinchuan	Ninxia

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients enrolled at year 1	The number of patients with osteoporosis or osteopenia enrolled in each medical centre at year 1	Year 1
Primary	Number of patients enrolled at year 2	The number of patients with osteoporosis or osteopenia enrolled in each medical centre at year 2	Year 2
Primary	Number of patients enrolled at year 3	The number of patients with osteoporosis or osteopenia enrolled in each medical centre at year 3	Year 3
Secondary	Number of patients screened at year 1	The number of patients screened for osteoporosis in each medical centre at year 1	Year 1
Secondary	Number of patients screened at year 2	The number of patients screened for osteoporosis in each medical centre at year 2	Year 2
Secondary	Number of patients screened at year 3	The number of patients screened for osteoporosis in each medical centre at year 3	Year 3
Secondary	The proportion of patients treated in compliance with guidelines at year 1	The proportion of patients treated in compliance with guidelines at year 1	Year 1
Secondary	The proportion of patients treated in compliance with guidelines at year 2	The proportion of patients treated in compliance with guidelines at year 2	Year 2
Secondary	The proportion of patients treated in compliance with guidelines at year 3	The proportion of patients treated in compliance with guidelines at year 3	Year 3
Secondary	Data integrity in network platform at year 1	The integrity of data recorded in network platform. Including general characteristics (name, sex, age, height, weight and race), medical history (onset age, chief complaint, history of fractures, medication history, previous history and family history), results of auxiliary examinations (DXEA is mandatory required, and other examinations may differ between medical centres, usually including serum calcium, serum phosphorus, serum total alkaline phosphatase, urine calcium, urine phosphorus, serum parathyroid hormone, X ray of vertebrae and so on), prescriptions, and follow-up data. At year 1.	Year 1
Secondary	Data integrity in network platform at year 2	The integrity of data recorded in network platform. Including general characteristics (name, sex, age, height, weight and race), medical history (onset age, chief complaint, history of fractures, medication history, previous history and family history), results of auxiliary examinations (DXEA is mandatory required, and other examinations may differ between medical centres, usually including serum calcium, serum phosphorus, serum total alkaline phosphatase, urine calcium, urine phosphorus, serum parathyroid hormone, X ray of vertebrae and so on), prescriptions, and follow-up data. At year 2.	Year 2
Secondary	Data integrity in network platform at year 3	The integrity of data recorded in network platform. Including general characteristics (name, sex, age, height, weight and race), medical history (onset age, chief complaint, history of fractures, medication history, previous history and family history), results of auxiliary examinations (DXEA is mandatory required, and other examinations may differ between medical centres, usually including serum calcium, serum phosphorus, serum total alkaline phosphatase, urine calcium, urine phosphorus, serum parathyroid hormone, X ray of vertebrae and so on), prescriptions, and follow-up data. At year 3.	Year 3