Clinical trial NCT03916289: A Tiered Management System of Osteoporosis in China
Official title: Establishing A National Tiered Diagnosis and Treatment System of Osteoporosis in China: A Pilot Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Osteoporosis
Osteopenia
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2019-04-16
Enrollment: 15000
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: Community population and outpatients in each clincal centre

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of patients enrolled at year 1
timeFrame: Year 1
measure: Number of patients enrolled at year 2
timeFrame: Year 2
measure: Number of patients enrolled at year 3
timeFrame: Year 3
Secondary outcomes:
measure: Number of patients screened at year 1
timeFrame: Year 1
measure: Number of patients screened at year 2
timeFrame: Year 2
measure: Number of patients screened at year 3
timeFrame: Year 3
measure: The proportion of patients treated in compliance with guidelines at year 1
timeFrame: Year 1
measure: The proportion of patients treated in compliance with guidelines at year 2
timeFrame: Year 2
measure: The proportion of patients treated in compliance with guidelines at year 3
timeFrame: Year 3
measure: Data integrity in network platform at year 1
timeFrame: Year 1
measure: Data integrity in network platform at year 2
timeFrame: Year 2
measure: Data integrity in network platform at year 3
timeFrame: Year 3
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Friendship Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Jishuitan Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing shijingshan hospital
state: Beijing
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Fuzhou
country: China
facility: Fujian Provincial Hospital
state: Fujian
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
city: Shijiazhuang
country: China
facility: The third hospital of hebei medical university
state: Hebei
city: Changsha
country: China
facility: The Second Hospital of Xiangya,Central South University
state: Hunan
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital
state: Jiangsu
city: Suzhou
country: China
facility: The Second Affiliated Hospital of Soochow University
state: Jiangsu
city: Nanchang
country: China
facility: Jiangxi Provincial People's Hospital
state: Jiangxi
city: Changchun
country: China
facility: The fourth hospital of jilin university
state: Jilin
city: Shenyang
country: China
facility: Shengjing hospital affiliated to China medical university
state: Liaoning
city: Yinchuan
country: China
facility: People's hospital of ningxia hui autonomous region
state: Ninxia
city: Shanghai
country: China
facility: The Sixth People's Hospital Affiliated to Shanghai Jiaotong University
state: Shanghai
city: Shanghai
country: China
facility: Huadong hospital affiliated to fudan university
state: Shanghai
city: Shanghai
country: China
facility: Shanghai first people's hospital affiliated to Shanghai jiaotong university
state: Shanghai
city: Shanghai
country: China
facility: Tongji hospital affiliated to tongji university
state: Shanghai
city: Xi'an
country: China
facility: Xi'an Red Cross hospital
state: Shannxi
city: Taiyuan
country: China
facility: The first affiliated hospital of shanxi medical university
state: Shanxi
city: Chengdu
country: China
facility: West China hospital of sichuan university
state: Sichuan
city: Chengdu
country: China
facility: Western theater general hospital
state: Sichuan
city: Tianjin
country: China
facility: Tianjin hospital
state: Tianjin
Study officials:
affiliation: Peking Union Medical College Hospital
name: The propotion of patients treated in comliance with guidelines Xia, MD
role: STUDY_CHAIR
References: