OsteoporosisNCT03916289
A Tiered Management System of Osteoporosis in China
An observational study of Osteoporosis and Osteopenia, run by Peking Union Medical College Hospital at 25 sites in China.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteoporosis, Osteopenia
- How many people
- 15,000 participants
- Where
- 25 sitesChina
- Study dates
- 1 Nov 2018to 30 Sep 2021
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Community population and outpatients in each clincal centre
Who may be able to join
- 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
Who cannot join
- Screened people who do not meet the inclusion criteria
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
China25 sites, 25 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Weibo Xia, MD
- Recruiting
Beijing Friendship Hospital
Beijing, Beijing Municipality
Hai Tang
- Recruiting
Beijing Jishuitan Hospital
Beijing, Beijing Municipality
Liang He
- Recruiting
Beijing shijingshan hospital
Beijing, Beijing Municipality
Hongyu Dong
- Recruiting
Chinese PLA General Hospital
Beijing, Beijing Municipality
Yu Pei
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality
Chunli Song
- Recruiting
The fourth hospital of jilin university
Changchun, Jilin
Mengmeng Zhang
- Recruiting
The Second Hospital of Xiangya,Central South University
Changsha, Hunan, 410011
Zhongjian Xie
- Recruiting
West China hospital of sichuan university
Chengdu, Sichuan
Decai Chen
- Recruiting
Western theater general hospital
Chengdu, Sichuan
Xiaolan Jin
- Recruiting
Fujian Provincial Hospital
Fuzhou, Fujian
Jianming Hou
- Recruiting
Guangdong Provincial People's Hospital
Guangzhou, Guangdong
Wen Wu
- Recruiting
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi
Yanan Huo
- Recruiting
Nanjing Drum Tower Hospital
Nanjing, Jiangsu
Hua Lin
- Recruiting
The Sixth People's Hospital Affiliated to Shanghai Jiaotong University
Shanghai, Shanghai Municipality, 200000
Zhenlin Zhang
- Recruiting
Huadong hospital affiliated to fudan university
Shanghai, Shanghai Municipality
Qun Cheng
- Recruiting
Shanghai first people's hospital affiliated to Shanghai jiaotong university
Shanghai, Shanghai Municipality
Li You
- Recruiting
Tongji hospital affiliated to tongji university
Shanghai, Shanghai Municipality
Keqin Zhang
- Recruiting
Shengjing hospital affiliated to China medical university
Shenyang, Liaoning
Qin Fu
- Recruiting
The third hospital of hebei medical university
Shijiazhuang, Hebei
Yukun Li
- Recruiting
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu
Youjia Xu
- Recruiting
The first affiliated hospital of shanxi medical university
Taiyuan, Shanxi
Jin Dong
- Recruiting
Tianjin hospital
Tianjin, Tianjin Municipality
Aijun Chao
- Recruiting
Xi'an Red Cross hospital
Xi'an, Shannxi
Yuhong Zeng
- Recruiting
People's hospital of ningxia hui autonomous region
Yinchuan, Ninxia
Jinhan Lv
About this study
Official title: Establishing A National Tiered Diagnosis and Treatment System of Osteoporosis in China: A Pilot Study
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.
- Conditions
- Osteoporosis, Osteopenia
- Being tested
- No intervention would be taken
- Medical subject headings
- Osteoporosis, Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention would be takenOther
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 being measured
The primary outcome is the main question the study is designed to answer.
Number of patients enrolled at year 1
The number of patients with osteoporosis or osteopenia enrolled in each medical centre at year 1
Measured: 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
Measured: 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
Measured: Year 3
Secondary outcomes (9)
Number of patients screened at year 1
The number of patients screened for osteoporosis in each medical centre at year 1
Measured: Year 1
Number of patients screened at year 2
The number of patients screened for osteoporosis in each medical centre at year 2
Measured: Year 2
Number of patients screened at year 3
The number of patients screened for osteoporosis in each medical centre at year 3
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Year 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study start1 Nov 2018
- Primary completion30 Sep 2021 (estimated)
- Study completion30 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15,000 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- The propotion of patients treated in comliance with guidelines Xia, MD, Study chair, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03916289
- Sponsor's protocol ID
- JS-1894
- Status last verified
- Apr 2019
- First submitted
- 10 Apr 2019
- Last updated
- 16 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing A National Tiered Diagnosis and Treatment System of Osteoporosis in China: A Pilot Study
- ClinicalTrials.gov ID
- NCT03916289
- Acronym / sponsor ID
- JS-1894
- Conditions
- Osteoporosis, Osteopenia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15,000 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 30 Sep 2021 (estimated)
- Study completion
- 30 Sep 2021 (estimated)
- First posted
- 16 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Community population and outpatients in each clincal centre
Key inclusion criteria (4 listed)
- Postmenopausal women or men aged 50 years or older
- 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
Key exclusion criteria (1 listed)
- Screened people who do not meet the inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention would be takenNo 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. | Other | – |
Primary outcome
Number of patients enrolled at year 1
Time frame: Year 1
The number of patients with osteoporosis or osteopenia enrolled in each medical centre at year 1
Number of patients enrolled at year 2
Time frame: Year 2
The number of patients with osteoporosis or osteopenia enrolled in each medical centre at year 2
Number of patients enrolled at year 3
Time frame: Year 3
The number of patients with osteoporosis or osteopenia enrolled in each medical centre at year 3
9 secondary outcomes
Number of patients screened at year 1
Time frame: Year 1
Number of patients screened at year 2
Time frame: Year 2
Number of patients screened at year 3
Time frame: Year 3
The proportion of patients treated in compliance with guidelines at year 1
Time frame: Year 1
The proportion of patients treated in compliance with guidelines at year 2
Time frame: Year 2
The proportion of patients treated in compliance with guidelines at year 3
Time frame: Year 3
Data integrity in network platform at year 1
Time frame: Year 1
Data integrity in network platform at year 2
Time frame: Year 2
Data integrity in network platform at year 3
Time frame: Year 3
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The propotion of patients treated in comliance with guidelines Xia, MD study chair
Peking Union Medical College Hospital
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoporosis and Osteopenia, run by Peking Union Medical College Hospital at 25 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Weibo Xia, MD (+86 69151552, xiaweibo8301@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients enrolled at year 1 (time frame: Year 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2019; AzTrials last refreshed its copy on 8 Nov 2026.