OsteoporosisNCT05721157
Osteoporotic Precisely Screening Using Chest Radiograph and Artificial Neural Network (OPSCAN)
A study testing AI-enabled Chest X-ray-based Screening Tool in people with Osteoporosis and Osteoporotic Fractures, run by National Defense Medical Center, Taiwan at 1 site in Taiwan.
Trial summary
Artificial Intelligence-assisted Diagnosis and Prognostication in Osteoporosis Using Chest X-ray Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Osteoporosis, Osteoporotic Fractures
- What is being tested?
- AI-enabled Chest X-ray-based Screening Tool
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,912 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2023to 30 Jun 2023
- Phase
- Interventional
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients recieved at least 1 chest X-ray examination in 2022
- More than 66% chest X-ray identified as high risk of osteoporosis by AI-CXR
Who cannot join
- Patients with history of at least 1 dual energy x-ray absorptiometry (DXA)
- Patients with history of osteoporosis or osteoportic fracture
- Patients recieved prescription anti-osteoporotic treatment (excluding vitamin D or calcium)
- Patients died before 01 Jan 2023
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Osteoporotic Precisely Screening Using Chest Radiograph and Artificial Neural Network (OPSCAN): a Randomized Controlled Trial
Artificial Intelligence-assisted Diagnosis and Prognostication in Osteoporosis Using Chest X-ray
- Conditions
- Osteoporosis, Osteoporotic Fractures
- Being tested
- AI-enabled Chest X-ray-based Screening Tool
- Medical subject headings
- Osteoporosis, Osteoporotic Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-enabled Chest X-ray-based Screening ToolOther
Primary care clinicians in the intervention group had access to the report, which displayed whether the AI-Chest X-ray result was positive or negative.The system will send a message to corresponding physicians if positive finding.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Patients randomized to intervention will have access to the screening tool. Receives: Other: AI-enabled Chest X-ray-based Screening Tool |
| Control | No intervention | Patients randomized to control will continue routine practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
newly diagnosed with osteoporosis
After performing an chest X-ray, the osteoporosis was followed.
Measured: Within 180 days
Secondary outcomes (2)
initiation of DXA examination
After performing an chest X-ray, the osteoporosis was followed.
Measured: Within 180 days
initiation of anti-osteoporotic treatment
After performing an chest X-ray, the osteoporosis was followed.
Measured: Within 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2023
- Study start1 Jan 2023
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
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.
- 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4,912 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Defense Medical Center, Taiwan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chin Lin, National Defense Medical Center, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05721157
- Sponsor's protocol ID
- NDMC2023001
- Status last verified
- Jul 2023
- First submitted
- 31 Jan 2023
- Last updated
- 11 Jul 2023
- Results posted
- No
- Data monitoring committee
- 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 11 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Osteoporotic Precisely Screening Using Chest Radiograph and Artificial Neural Network (OPSCAN): a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05721157
- Acronym / sponsor ID
- NDMC2023001
- Conditions
- Osteoporosis, Osteoporotic Fractures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,912 participants (actual)
- Lead sponsor
- National Defense Medical Center, TaiwanUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 9 Feb 2023 (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.
Artificial Intelligence-assisted Diagnosis and Prognostication in Osteoporosis Using Chest X-ray
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: AI-enabled Chest X-ray-based Screening ToolPatients randomized to intervention will have access to the screening tool. |
| Control | No intervention | –Patients randomized to control will continue routine practice. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients recieved at least 1 chest X-ray examination in 2022
- More than 66% chest X-ray identified as high risk of osteoporosis by AI-CXR
Key exclusion criteria (4 listed)
- Patients with history of at least 1 dual energy x-ray absorptiometry (DXA)
- Patients with history of osteoporosis or osteoportic fracture
- Patients recieved prescription anti-osteoporotic treatment (excluding vitamin D or calcium)
- Patients died before 01 Jan 2023
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 |
|---|---|---|
| AI-enabled Chest X-ray-based Screening ToolPrimary care clinicians in the intervention group had access to the report, which displayed whether the AI-Chest X-ray result was positive or negative.The system will send a message to corresponding physicians if positive finding. | Other | Intervention |
Primary outcome
newly diagnosed with osteoporosis
Time frame: Within 180 days
After performing an chest X-ray, the osteoporosis was followed.
2 secondary outcomes
initiation of DXA examination
Time frame: Within 180 days
initiation of anti-osteoporotic treatment
Time frame: Within 180 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2023.
- 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 record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI-enabled Chest X-ray-based Screening Tool in people with Osteoporosis and Osteoporotic Fractures, run by National Defense Medical Center, Taiwan at 1 site 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 2 inclusion and 4 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: finished, as of the sponsor's last update on 11 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
newly diagnosed with osteoporosis (time frame: Within 180 days). 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 11 Jul 2023.