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.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

15,000

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Nov 2018

Typical duration for all trials

Geographic Reach

1 country

25 active sites

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.9 years study duration

Study Start

First participant enrolled

November 1, 2018

Completed

5 months until next milestone

First Submitted

Initial submission to the registry

April 10, 2019

Completed

6 days until next milestone

First Posted

Study publicly available on registry

April 16, 2019

Completed

2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed

Last Updated

April 16, 2019

Status Verified

April 1, 2019

Enrollment Period

2.9 years

First QC Date

April 10, 2019

Last Update Submit

April 12, 2019

Conditions

Osteoporosis Osteopenia

Outcome Measures

Primary Outcomes (3)

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 Outcomes (9)

Number of patients screened at year 1
Year 1
Number of patients screened at year 2
Year 2
Number of patients screened at year 3
Year 3
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
Year 2
+4 more secondary outcomes

Interventions

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.

Eligibility Criteria

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Community population and outpatients in each clincal centre

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Peking Union Medical College Hospitallead

Study Sites (25)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

Beijing Friendship Hospital