Actively Recruiting
Artificial Intelligence-Guided Diagnosis for High-Risk Osteoporosis Populations: A Pragmatic Randomized Clinical Trial
Led by Taichung Veterans General Hospital · Updated on 2026-06-02
1180
Participants Needed
3
Research Sites
21 weeks
Total Duration
On this page
Sponsors
T
Taichung Veterans General Hospital
Lead Sponsor
M
Ministry of Health and Welfare, Taiwan
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research focuses on adults aged 40 to 80 years who are at high risk for osteoporosis. It aims to evaluate the clinical effectiveness and economic impact of an artificial intelligence (AI)-guided diagnosis system called VeriOsteo OP. The goal is to support reimbursement decisions within the national health insurance system by providing scientific evidence on the value of AI-based smart medical devices for early osteoporosis screening and management. Participants are randomly assigned in a 2:1 ratio to either receive the AI-guided diagnosis using VeriOsteo OP or the standard routine diagnosis for osteoporosis. Those in the AI group undergo the AI assessment followed by confirmation with a DXA scan, which is the gold standard for bone mineral density (BMD) evaluation. The study is conducted across multiple medical centers and includes a follow-up period averaging 18 months to assess diagnostic consistency and clinical outcomes. During the study, participants will have regular follow-up visits every six months up to 18 months to monitor bone mineral density improvements, incidence of bone fractures, and all-cause mortality. Data collection includes diagnostic reports, clinical evaluations, and economic assessments to measure healthcare cost reduction and clinical benefits. The study also ensures data privacy and security throughout the research process, with the ultimate aim of guiding national healthcare policy and advancing AI-driven medical technology adoption.
CONDITIONS
Brief Title
Artificial Intelligence-Guided Diagnosis for High-Risk Osteoporosis Populations: A Pragmatic Randomized Clinical Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged between 40 to 80 years old
- Identified as high-risk by the Osteoporosis Self-Assessment Tool for Taiwan Postmenopausal Women (OSTAi) < -1 or Male Osteoporosis Self-Assessment Tool for Taiwan (MOSTAi) 1 based on age and weight
- Had a chest x-ray within the past year
You will not qualify if you...
- Younger than 40 years old
- Older than 80 years old
- Body mass index (BMI) less than 18 kg/m2 or greater than 30 kg/m2
- Pregnant within the past year
- Diagnosed with osteoporosis within the past two years
- Had DXA imaging for bone mineral density within the past two years
- History of metabolic bone disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single assessment at baseline
Participants in the intervention group undergo VeriOsteo OP AI assessment followed by DXA confirmation to assess osteoporosis risk, while control participants undergo standard-of-care diagnosis.
1 baseline visit (in-person)
Duration - Up to 18 months
Participants are monitored for bone mineral density improvement, incidence of bone fractures, and all-cause mortality.
Visits every 6 months up to 18 months
Trial Site Locations
Total: 3 locations
1
Show Chwan Memorial Hospital
Changhua, Taiwan
Actively Recruiting
2
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan
Actively Recruiting
3
Taichung Veterans General Hospital
Taichung, Taiwan
Actively Recruiting
Research Team
W
WU WU ZHAN, M.B.A.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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