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A Tiered Management System of Osteoporosis in China

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03916289
Enrollment
15000
Registered
2019-04-16
Start date
2018-11-01
Completion date
2021-09-30
Last updated
2019-04-16

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

Conditions

Osteopenia, Osteoporosis

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.

Interventions

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.

Sponsors

Peking Union Medical College Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of patients enrolled at year 1Year 1The number of patients with osteoporosis or osteopenia enrolled in each medical centre at year 1
Number of patients enrolled at year 2Year 2The number of patients with osteoporosis or osteopenia enrolled in each medical centre at year 2
Number of patients enrolled at year 3Year 3The number of patients with osteoporosis or osteopenia enrolled in each medical centre at year 3

Secondary

MeasureTime frameDescription
The proportion of patients treated in compliance with guidelines at year 1Year 1The proportion of patients treated in compliance with guidelines at year 1
The proportion of patients treated in compliance with guidelines at year 2Year 2The proportion of patients treated in compliance with guidelines at year 2
The proportion of patients treated in compliance with guidelines at year 3Year 3The proportion of patients treated in compliance with guidelines at year 3
Number of patients screened at year 1Year 1The number of patients screened for osteoporosis in each medical centre at year 1
Data integrity in network platform at year 2Year 2The 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.
Data integrity in network platform at year 3Year 3The 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.
Data integrity in network platform at year 1Year 1The 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.
Number of patients screened at year 2Year 2The number of patients screened for osteoporosis in each medical centre at year 2
Number of patients screened at year 3Year 3The number of patients screened for osteoporosis in each medical centre at year 3

Countries

China

Contacts

Primary ContactWeibo Xia, MD
xiaweibo8301@163.com+86 69151552

Outcome results

None listed

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