A Tiered Management System of Osteoporosis in China

Study Overview
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Brief Summary
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There is a management gap in China. This study aims to establish a tiered management system of osteoporosis for Chinese patients. Including: 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. Establishing a muti-level hospital collaboration, doctor-patient interaction management model of osteoporosis. To explore and establish a early warning and screening pathways for osteoporosis.

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

Conditions
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Osteoporosis, Osteopenia

Intervention / Treatment
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* Other: No intervention would be taken


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Postmenopausal women or men aged 50 years or older Conform to the diagnosis of osteoporosis or osteopenia as followings: 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 Have at least once major osteoporotic fracture Exclusion Criteria: Screened people who do not meet the inclusion criteria
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients screened at year 1 | The number of patients screened for osteoporosis in each medical centre at year 1 | Year 1 | 
| Number of patients screened at year 2 | The number of patients screened for osteoporosis in each medical centre at year 2 | Year 2 | 
| Number of patients screened at year 3 | The number of patients screened for osteoporosis in each medical centre at year 3 | Year 3 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 |