NCT07421713Recruiting
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
A Retrospective Multi-centre Paired Accuracy Study to Evaluate the Performance of Osteo Signal Against the Dual-energy X-ray Absorptiometry (DXA) for Opportunistic Osteoporosis Screening
Source: ClinicalTrials.gov · Last updated 23 Oct 2026
Brief summary (registry, in English)
The goal of this study is to assess the performance of an artificial intelligence software (Osteo Signal) in detecting osteoporosis risk in adults 50 years and older. The main question it aims to answer is: What is the accuracy of the software in detecting osteoporosis risk on chest x-ray images as compared to the standard technique of dual-energy x-ray absorptiometry (DXA)? There is no direct involvement of participants in this study as it will use data from individuals who have already had a chest x-ray and a DXA scan taken in the past.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 595 (estimated)
- First submitted
- 12 Feb 2026
- Start date
- 10 Feb 2026
- Primary completion date
- 30 Nov 2026
- Lead sponsor
- Promedius Inc
- Diseases
- Osteoporosis
- NCT number
- NCT07421713
What you commit to
- Study type: Observational
- Planned participants: 595
- From 10 Feb 2026 to the primary completion date, 30 Nov 2026
- 3 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous diagnosis or treatment of Osteoporosis prior to the DXA scan used in the Study.
- diagnosis of osteoporosis (T-score ≤-2.5), or current/recent anti- osteoporotic medications, within 12 months prior to the DXA scan used in the study.
- Current or recent anti-osteoporotic medications for 3 months (91 days) continuously prior to the Chest x-ray used in the Study.
- Diagnosis of any metabolic bone disease prior to the DXA scan used in the study.
- Major Chest Wall or Spinal Deformities, including but not limited to:
- Severe structural deformities: Thoracic scoliosis with Cobb angle \>40°, severe kyphosis, or chest wall deformities (pectus excavatum/carinatum) affecting \>30% of the thoracic cage.
- Surgical hardware: Previous thoracic/spinal surgery with metallic implants obscuring anatomical landmarks required for AI analysis.
- Pathological conditions: Extensive pulmonary consolidation, pleural effusion, lesions or masses obscuring \>30% of thoracic skeletal structures
Other illness
- Diagnosis of metabolic bone disease other than Osteoporosis or Osteopenia, up to a maximum of 3 months (91 days) after the DXA scan.
Other
- Non-diagnostic Quality or Incomplete Imaging of:
- DXA scan inadequacy: Missing T-score from a technically inadequate scan.
- PA Chest X-ray technical inadequacy: Non-PA projection, significant motion artefacts, inadequate visualisation of thoracic structures, or missing DICOM metadata.
- Image format incompatibility: Non-DICOM format or corrupted image files that would prevent AI analysis
- PA Chest X-ray \> ±6 months from the date of the DXA scan.
- Subject has opted out of confidential data being used for research purposes
Who the study is looking for
- Age ≥50 years at the time of chest X-ray
- Availability of
- Posteroanterior (PA) Chest X-ray and
- DXA scan with a valid T-score measurement where both the DXA scan and Chest x-ray examinations were performed within 6 months (182 days) of each other and
- Available X-ray and DXA scans performed on or after 01-Jan-2010.
- Complete metadata (sex and age) available on PACS or hospital records.
Age in the registry: 50 years to - · Sex: All · Accepts healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Barts Health NHS Trust Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| Mid and South Essex NHS Foundation Trust Coordinator of this site? Confirm its status | Westcliff-on-Sea | United Kingdom | Recruiting |
| Erasmus University Medical Center Rotterdam Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.