OsteoporosisNCT07620834
Artificial Intelligence-Guided Diagnosis for High-Risk Osteoporosis Populations: A Pragmatic Randomized Clinical Trial
A study testing VeriOsteo OP in people with Osteoporosis, run by Taichung Veterans General Hospital at 3 sites in Taiwan.
Trial summary
Project Summary I. Project Objectives With the rapid advancement of medical technology, smart medical devices have become one of the key components of modern healthcare. However, integrating these emerging technologies into the national health insurance (NHI) reimbursement system while ensuring their clinical value… Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis
- What is being tested?
- VeriOsteo OP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,180 participants
- Where
- 3 sitesTaiwan
- Study dates
- 13 Mar 2026to 12 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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) ≦11 based on the individual's age and weight (kg)
- Had chest x-ray within one year
Who cannot join
- Age < 40 years old
- Age >80 years old
- BMI< 18 kg/m2or >30 kg/m2
- Pregnant in prior one year
- Recorded diagnosis of osteoporosis within the past two years
- History of prior DXA imaging (prior quantification of BMD) within 2 years
- History of metabolic bone disease
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan3 sites, 3 recruiting
- Recruiting
Show Chwan Memorial Hospital
Changhua
Chu Pei-Yi, MD, 0975611855, chu.peiyi@msa.hinet.net
- Recruiting
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City
Jaw Yuan Wang, MD, 07-3121101, 1030771@kmuh.org.tw
- Recruiting
Taichung Veterans General Hospital
Taichung
Kun Hui Chen, MD, 04-23592525#5100, khc@vghtc.gov.tw
About this study
Project Summary
- Project Objectives
Read more
With the rapid advancement of medical technology, smart medical devices have become one of the key components of modern healthcare. However, integrating these emerging technologies into the national health insurance (NHI) reimbursement system while ensuring their clinical value and economic benefits remains a major challenge worldwide.
The primary goal of this project is to assist commercialized smart medical device products-those that have passed TFDA review and seek NHI reimbursement-in conducting comprehensive evaluations of their clinical effectiveness and medical economic impact. Through scientific data and standardized impact assessment procedures, the project aims to provide localized evidence to support reimbursement policy decisions and facilitate the market adoption of smart medical technologies. Ultimately, this project seeks to balance therapeutic efficacy and cost control, offering a scientific foundation for NHI decision-making and paving the way for the sustainable development of AI-driven healthcare innovations.
II. Implementation Methods
- Multi-center Collaborative Network This project will be led by Taichung Veterans General Hospital (TCVGH) as the principal site, with collaboration from Kaohsiung Medical University Chung-Ho Memorial Hospital and Changhua Show Chwan Memorial Hospital. This cross-institutional, cross-regional alliance ensures diverse clinical samples, enhances the representativeness of study results, and allows evaluation of AI medical devices across different healthcare systems and environments.
- Clinical Trial Design and Implementation for Smart Medical Devices The project will design and execute systematic clinical trials for smart medical devices using methodologies such as randomized controlled trials (RCTs), before-and-after studies, pragmatic RCTs (PCTs), cluster RCTs, and stepped-wedge RCTs. These rigorous designs will ensure scientific validity, reproducibility, and practical feasibility in real-world clinical settings.
- Health Economic Evaluation A key component of this project is the medical economic assessment, conducted by experienced health economists through cost-effectiveness analysis. The evaluation will focus on how smart medical devices reduce healthcare costs, improve diagnostic efficiency, and enhance treatment outcomes, quantifying their economic value within the NHI system. This evidence will guide policy makers in making data-driven reimbursement decisions.
- Standardized Impact Assessment Process To ensure high-quality research, the project will establish a comprehensive standardized impact assessment framework covering trial design, data collection, statistical analysis, economic evaluation, and ethical review. This standardized approach not only improves the precision of the study but also accelerates the clinical translation of AI medical devices through streamlined application and review processes.
- Research Case Study and Clinical Application The featured case study in this project is "VeriOsteo OP® Smart Bone Screening System," which targets early osteoporosis screening among adults aged 40 to 80 years in high-risk groups. This study will evaluate the clinical accuracy of AI-based osteoporosis screening and assess its economic contribution to healthcare cost reduction. The findings will directly inform the Ministry of Health and Welfare's NHI Administration in formulating reimbursement standards for AI medical devices.
- Data Sharing and Information Security Throughout the project, all research data collection, exchange, and sharing will strictly adhere to cybersecurity and privacy regulations. The AI models involved will undergo validation to ensure the reliability and scientific rigor of the results. Furthermore, the project will promote collaboration between manufacturers and healthcare institutions to support the adoption of smart medical technologies.
- Final Outcomes and Future Development
The final deliverables will include a comprehensive evaluation report on the clinical and economic performance of the AI medical device, along with recommendations for NHI reimbursement application. The results will provide a reference model for future AI medical devices entering the reimbursement system and further advance the field of smart healthcare. In the long term, the center aims to expand its research to other disease domains while strengthening data security and ethical oversight to ensure the feasibility and credibility of AI applications in clinical practice.
III. Expected Outcomes and Future Vision
By implementing a multi-center collaborative framework, this project aims to promote clinical adoption and economic evaluation of smart medical devices, offering concrete data to support NHI policy-making. Over time, the project is expected to establish a robust evaluation system for AI medical devices, facilitate broader market adoption, and enhance patient outcomes whi
- Conditions
- Osteoporosis
- Being tested
- VeriOsteo OP
- Keywords
- Software as a Medical Device (SaMD), Clinical Impact Analysis, Health Economics, Standardization of NHI Reimbursement
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VeriOsteo OPDevice
Participants in the intervention group undergo VeriOsteo OP AI assessment followed by DXA confirmation. The AI system generates a diagnostic report identifying individuals at high risk for osteoporosis. Results are used to guide clinical decision-making and evaluate the diagnostic consistency between the AI-guided system and the gold-standard DXA assessment.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Participants will receive AI-guided diagnosis for osteoporosis risk assessment. This group follows a 2:1 randomization ratio. Receives: Device: VeriOsteo OP |
| Control Group | No intervention | Participants will receive standard-of-care (routine diagnosis) for osteoporosis assessment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective is to evaluate the clinical effectiveness in terms of the improvement of BMD, of AI-guided diagnosis (VeriOsteo OP)
The primary endpoint of this study is the change in Bone Mineral Density (BMD) expressed as a T-score, measured by Dual-energy X-ray Absorptiometry (DXA). The T-score is a standardized metric comparing bone density to a healthy young adult. While there is no theoretical absolute minimum or maximum value, typical clinical values range from -5.0 to +2.0. According to the International Osteoporosis Foundation (IOF) and Taiwan 2020 guidelines, a T-score of -1.0 or higher is normal, between -1.0 and -2.5 indicates osteopenia, and a T-score of -2.5 or lower (≤ -2.5) indicates osteoporosis. Therefore, a higher (more positive) T-score represents a better outcome (higher bone density). To avoid inflating the detection rate for osteoporosis based on the protocolized DXA at baseline in the intervention arm, a positive AI screen was required to be present to count the chest X-ray findings for the purpose of the primary end point.
Measured: Up to the end of follow-up (average 18 months)
Secondary outcomes (2)
Incidence of Bone Fractures
he incidence of bone fractures, including hip fracture, vertebral fracture, wrist fracture, and other fractures. Bone fractures will be identified from the participant interviews and confirmed by International Classification of Diseases (ICD) codes extracted from electronic health records (EHRs) across the three study sites.
Measured: Every 6 months up to 18 months
All-Cause Mortality
The incidence of all-cause death. Participant status will be followed by telephone and verified through electronic health records (EHRs) from the three study sites.
Measured: Every 6 months up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2026
- Study start13 Mar 2026
- Primary completion17 Jun 2026 (estimated)
- Study completion12 Nov 2026 (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 Taichung Veterans General 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study will adopt before-after clinical trial with control design. The modified intention-totreat (mITT) approach will be used. Participants at high risk for osteoporosis, as defined by OSTAior MOSTAi, will be enrolled and randomized 2:1 into either the intervention or control group byan independent database programmer from Taichung Veterans General Hospital.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health and Welfare, Taiwan
- Responsible party
- Principal investigator, Kun-Hui Chen, Taichung Veterans General Hospital
- Investigators
- Kun Hui Chen, MD, Principal investigator, Taichung Veterans General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07620834
- Sponsor's protocol ID
- SC251020B
- Status last verified
- May 2026
- First submitted
- 14 May 2026
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: As this is a multi-center study, the sharing of individual participant data (IPD) would require joint approval from the Institutional Review Boards (IRBs) of all three participating hospitals. Given the complex regulatory procedures and strict privacy protocols involved, the data will not be made publicly available at this time.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Intelligence-Guided Diagnosis for High-Risk Osteoporosis Populations: A Pragmatic Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07620834
- Acronym / sponsor ID
- SC251020B
- Conditions
- Osteoporosis
- Keywords
- Software as a Medical Device (SaMD), Clinical Impact Analysis, Health Economics, Standardization of NHI Reimbursement
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,180 participants (estimated)
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Collaborators
- Ministry of Health and Welfare, Taiwan
- Study start
- 13 Mar 2026 (actual)
- Primary completion
- 17 Jun 2026 (estimated)
- Study completion
- 12 Nov 2026 (estimated)
- First posted
- 2 Jun 2026 (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.
Project Summary
- Project Objectives
With the rapid advancement of medical technology, smart medical devices have become one of the key components of modern healthcare. However, integrating these emerging technologies into the national health insurance (NHI) reimbursement system while ensuring their clinical value and economic benefits remains a major challenge worldwide.
The primary goal of this project is to assist commercialized smart medical device products-those that have passed TFDA review and seek NHI reimbursement-in conducting comprehensive evaluations of their clinical effectiveness and medical economic impact. Through scientific data and standardized impact assessment procedures, the project aims to provide localized evidence to support reimbursement policy decisions and facilitate the market adoption of smart medical technologies. Ultimately, this project seeks to balance therapeutic efficacy and cost control, offering a scientific foundation for NHI decision-making and paving the way for the sustainable development of AI-driven healthcare innovations.
II. Implementation Methods
- Multi-center Collaborative Network This project will be led by Taichung Veterans General Hospital (TCVGH) as the principal site, with collaboration from Kaohsiung Medical University Chung-Ho Memorial Hospital and Changhua Show Chwan Memorial Hospital. This cross-institutional, cross-regional alliance ensures diverse clinical samples, enhances the representativeness of study results, and allows evaluation of AI medical devices across different healthcare systems and environments.
- Clinical Trial Design and Implementation for Smart Medical Devices The project will design and execute systematic clinical trials for smart medical devices using methodologies such as randomized controlled trials (RCTs), before-and-after studies, pragmatic RCTs (PCTs), cluster RCTs, and stepped-wedge RCTs. These rigorous designs will ensure scientific validity, reproducibility, and practical feasibility in real-world clinical settings.
- Health Economic Evaluation A key component of this project is the medical economic assessment, conducted by experienced health economists through cost-effectiveness analysis. The evaluation will focus on how smart medical devices reduce healthcare costs, improve diagnostic efficiency, and enhance treatment outcomes, quantifying their economic value within the NHI system. This evidence will guide policy makers in making data-driven reimbursement decisions.
- Standardized Impact Assessment Process To ensure high-quality research, the project will establish a comprehensive standardized impact assessment framework covering trial design, data collection, statistical analysis, economic evaluation, and ethical review. This standardized approach not only improves the precision of the study but also accelerates the clinical translation of AI medical devices through streamlined application and review processes.
- Research Case Study and Clinical Application The featured case study in this project is "VeriOsteo OP® Smart Bone Screening System," which targets early osteoporosis screening among adults aged 40 to 80 years in high-risk groups. This study will evaluate the clinical accuracy of AI-based osteoporosis screening and assess its economic contribution to healthcare cost reduction. The findings will directly inform the Ministry of Health and Welfare's NHI Administration in formulating reimbursement standards for AI medical devices.
- Data Sharing and Information Security Throughout the project, all research data collection, exchange, and sharing will strictly adhere to cybersecurity and privacy regulations. The AI models involved will undergo validation to ensure the reliability and scientific rigor of the results. Furthermore, the project will promote collaboration between manufacturers and healthcare institutions to support the adoption of smart medical technologies.
- Final Outcomes and Future Development
The final deliverables will include a comprehensive evaluation report on the clinical and economic performance of the AI medical device, along with recommendations for NHI reimbursement application. The results will provide a reference model for future AI medical devices entering the reimbursement system and further advance the field of smart healthcare. In the long term, the center aims to expand its research to other disease domains while strengthening data security and ethical oversight to ensure the feasibility and credibility of AI applications in clinical practice.
III. Expected Outcomes and Future Vision
By implementing a multi-center collaborative framework, this project aims to promote clinical adoption and economic evaluation of smart medical devices, offering concrete data to support NHI policy-making. Over time, the project is expected to establish a robust evaluation system for AI medical devices, facilitate broader market adoption, and enhance patient outcomes whi
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This study will adopt before-after clinical trial with control design. The modified intention-totreat (mITT) approach will be used. Participants at high risk for osteoporosis, as defined by OSTAior MOSTAi, will be enrolled and randomized 2:1 into either the intervention or control group byan independent database programmer from Taichung Veterans General Hospital.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Device: VeriOsteo OPParticipants will receive AI-guided diagnosis for osteoporosis risk assessment. This group follows a 2:1 randomization ratio. |
| Control Group | No intervention | –Participants will receive standard-of-care (routine diagnosis) for osteoporosis assessment. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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) ≦11 based on the individual's age and weight (kg)
- Had chest x-ray within one year
Key exclusion criteria (7 listed)
- Age < 40 years old
- Age >80 years old
- BMI< 18 kg/m2or >30 kg/m2
- Pregnant in prior one year
- Recorded diagnosis of osteoporosis within the past two years
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 |
|---|---|---|
| VeriOsteo OPParticipants in the intervention group undergo VeriOsteo OP AI assessment followed by DXA confirmation. The AI system generates a diagnostic report identifying individuals at high risk for osteoporosis. Results are used to guide clinical decision-making and evaluate the diagnostic consistency between the AI-guided system and the gold-standard DXA assessment. | Device | Intervention Group |
Primary outcome
The primary objective is to evaluate the clinical effectiveness in terms of the improvement of BMD, of AI-guided diagnosis (VeriOsteo OP)
Time frame: Up to the end of follow-up (average 18 months)
The primary endpoint of this study is the change in Bone Mineral Density (BMD) expressed as a T-score, measured by Dual-energy X-ray Absorptiometry (DXA). The T-score is a standardized metric comparing bone density to a healthy young adult. While there is no theoretical absolute minimum or maximum value, typical clinical values range from -5.0 to +2.0. According to the International Osteoporosis Foundation (IOF) and Taiwan 2020 guidelines, a T-score of -1.0 or higher is normal, between -1.0 and -2.5 indicates osteopenia, and a T-score of -2.5 or lower (≤ -2.5) indicates osteoporosis. Therefore, a higher (more positive) T-score represents a better outcome (higher bone density). To avoid inflating the detection rate for osteoporosis based on the protocolized DXA at baseline in the intervention arm, a positive AI screen was required to be present to count the chest X-ray findings for the purpose of the primary end point.
2 secondary outcomes
Incidence of Bone Fractures
Time frame: Every 6 months up to 18 months
All-Cause Mortality
Time frame: Every 6 months up to 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. As this is a multi-center study, the sharing of individual participant data (IPD) would require joint approval from the Institutional Review Boards (IRBs) of all three participating hospitals. Given the complex regulatory procedures and strict privacy protocols involved, the data will not be made publicly available at this time.
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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.
Kun Hui Chen, MD principal investigator
Taichung Veterans General Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VeriOsteo OP in people with Osteoporosis, run by Taichung Veterans General Hospital at 3 sites in Taiwan.
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 3 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Taiwan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact WU WU ZHAN, M.B.A. (04-23592525#3973, tcvghaicenter@vghtc.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary objective is to evaluate the clinical effectiveness in terms of the improvement of BMD, of AI-guided diagnosis (VeriOsteo OP) (time frame: Up to the end of follow-up (average 18 months)). 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 2 Jun 2026.