Actively Recruiting
A Retrospective Multi-centre Paired Accuracy Study to Evaluate the Performance of Osteo Signal AI Software Using Chest X-rays Compared to Dual-energy X-ray Absorptiometry (DXA) for Osteoporosis Screening in Adults 50 Years and Older
Led by Promedius Inc · Updated on 2026-02-19
595
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the performance of an artificial intelligence software called Osteo Signal in detecting the risk of osteoporosis in adults aged 50 years and older. The study aims to determine how accurately the software can identify osteoporosis risk using chest x-ray images compared to the standard method of dual-energy x-ray absorptiometry (DXA). This observational study uses past imaging data collected from individuals who have previously undergone both chest x-rays and DXA scans. The main intervention being assessed is the Osteo Signal AI software, which analyzes chest x-rays to screen for osteoporosis risk. There are no new treatments or procedures for participants since the study is retrospective and uses existing imaging data collected within six months of each other. The study involves comparing the AI software's results against the DXA scan findings to classify bone status. Participants are not directly involved as the study uses existing medical images and records, including chest x-rays and DXA scans performed after January 2010. Researchers will analyze these images along with metadata such as age and sex. The primary outcome is the accuracy of classifying bone status as osteoporosis or non-osteoporosis. Secondary outcomes include more detailed classifications such as osteopenia and normal bone status. The study is designed to monitor the software's performance without requiring additional visits or interventions from participants.
CONDITIONS
Brief Title
A Study Evaluating the Performance of Using AI Software and Chest X-rays to Screen for Osteoporosis as Compared to Standard DXA Scans in Patients 50 Years and Older
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 50 years or older at the time of chest X-ray
- Availability of posteroanterior (PA) chest X-ray and DXA scan with a valid T-score performed within 6 months (182 days) of each other
- Both imaging studies performed on or after January 1, 2010
- Complete metadata including sex and age available in medical records
You will not qualify if you...
- Non-diagnostic or incomplete imaging including missing T-score from DXA or technically inadequate scans
- Chest X-ray not in PA projection, with motion artifacts, poor visualization of thoracic structures, or missing metadata
- Image files in non-DICOM format or corrupted, preventing AI analysis
- Chest X-ray taken more than 6 months before or after the DXA scan
- Prior diagnosis of osteoporosis or treatment with anti-osteoporotic medications within 12 months before the DXA scan
- Anti-osteoporotic medication use for 3 months continuously before the chest X-ray
- Diagnosis of metabolic bone diseases other than osteoporosis or osteopenia before or up to 3 months after the DXA scan
- Major chest wall or spinal deformities such as severe scoliosis with Cobb angle >40°, severe kyphosis, or chest wall deformities affecting over 30% of the thoracic cage
- Presence of surgical hardware obscuring anatomical landmarks
- Significant pulmonary conditions obscuring thoracic skeletal structures
- Opted out of confidential data use for research purposes
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 or remote) for eligibility confirmation based on medical records and imaging availability
Duration - Up to 6 months retrospective data review period
Participants undergo evaluation involving review of existing chest X-rays and DXA scans to assess bone status using AI software compared to standard methods.
No additional visits; evaluation uses previously collected imaging and medical records
Duration - Ongoing as per medical record timeline
Participants' bone health status is monitored through collected imaging data without active intervention.
No study visits; observational follow-up through medical records
Trial Site Locations
Total: 3 locations
1
Erasmus University Medical Center Rotterdam,
Rotterdam, Netherlands, 3015 GD
Not Yet Recruiting
2
Mid and South Essex NHS Foundation Trust
Westcliff-on-Sea, Essex, United Kingdom, SS0 0RY
Not Yet Recruiting
3
Barts Health NHS Trust
London, United Kingdom, E1 4DG
Actively Recruiting
Research Team
K
Kim Bensalem
J
Jung Jinho
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
Frequently Asked Questions
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