Osteoporosis, OsteopeniaNCT07421713
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
An observational study of Osteoporosis, Osteopenia, run by Promedius Inc at 3 sites in 2 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis, Osteopenia
- What is being tested?
- Osteo Signal
- Type of treatment
- Medical device
- How many people
- 595 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 10 Feb 2026to 31 Dec 2026
- Phase
- Observational
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients selected hospitals in the Netherlands and UK that have previously had chest x-rays and DXA scans
Who may be able to join
- 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.
Who cannot join
- 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.
- Previous diagnosis or treatment of Osteoporosis prior to the DXA scan used in the Study.
Show all 15Show fewer
- 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.
- Diagnosis of metabolic bone disease other than Osteoporosis or Osteopenia, up to a maximum of 3 months (91 days) after the DXA scan.
- 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
- Subject has opted out of confidential data being used for research purposes
Trial locations and contacts
3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 2 countries
United Kingdom2 sites, 2 recruiting
- Recruiting
Barts Health NHS Trust
London, E1 4DG
Giuseppe Ruocco
- Recruiting
Mid and South Essex NHS Foundation Trust
Westcliff-on-Sea, Essex, SS0 0RY
Anupama C Nandagudi, Consultant Rheumatologist
Netherlands1 site, 1 recruiting
- Not yet recruiting
Erasmus University Medical Center Rotterdam
Rotterdam, Netherlands, 3015 GD
Jacob J Visser, Musculoskeletal Radiologist
About this study
Official title: 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
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.
- Conditions
- Osteoporosis, Osteopenia
- Being tested
- Osteo Signal
- Keywords
- Osteoporosis, Bone Diseases, Metabolic
- Medical subject headings
- Osteoporosis, Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteo SignalDevice
Artificial Intelligence (AI) software
What is being measured
The primary outcome is the main question the study is designed to answer.
Two class bone status classification (osteoporosis/non osteoporosis)
Device output against the lowest DXA as measured by sensitivity, specificity, and area under the ROC curve (AUC)
Measured: At a time following the participant having had a chest x-ray and DXA scan within 6 months of each other
Secondary outcomes (2)
Three class bone status classification (osteoporosis/osteopenia/normal)
Device output against the lowest DXA as measured by area under the ROC curve (AUC), overall per cent agreement, and weighted Cohen's kappa
Measured: At a time following the participant having had a chest x-ray and DXA scan within 6 months of each other
Classification for osteoporosis and osteopenia
Positive predictive value (PPV) and negative predictive value (NPV) for osteoporosis and osteopenia classifications
Measured: At a time following the participant having had a chest x-ray and DXA scan within 6 months of each other
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start10 Feb 2026
- Primary completion30 Nov 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoporosis, OsteopeniaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 595 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Promedius Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jacob J Visser, Musculoskeletal Radiologist, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07421713
- Sponsor's protocol ID
- CIP-OSTEO3-001
- Status last verified
- Oct 2026
- First submitted
- 12 Feb 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD will be shared. The trial data is proprietary and part of a product development program.
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07421713
- Acronym / sponsor ID
- CIP-OSTEO3-001
- Conditions
- Osteoporosis, Osteopenia
- Keywords
- Osteoporosis, Bone Diseases, Metabolic
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 595 participants (estimated)
- Lead sponsor
- Promedius IncIndustry (pharma, biotech, devices)
- Study start
- 10 Feb 2026 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 19 Feb 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients selected hospitals in the Netherlands and UK that have previously had chest x-rays and DXA scans
Key inclusion criteria (6 listed)
- Age ≥50 years at the time of chest X-ray
- Availability of
- Complete metadata (sex and age) available on PACS or hospital records.
Key exclusion criteria (15 listed)
- Non-diagnostic Quality or Incomplete Imaging of:
- Previous diagnosis or treatment of Osteoporosis prior to the DXA scan used in the Study.
- Diagnosis of any metabolic bone disease prior to the DXA scan used in the study.
- Diagnosis of metabolic bone disease other than Osteoporosis or Osteopenia, up to a maximum of 3 months (91 days) after the DXA scan.
- Major Chest Wall or Spinal Deformities, including but not limited to:
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 |
|---|---|---|
| Osteo SignalArtificial Intelligence (AI) software | Device | – |
Primary outcome
Two class bone status classification (osteoporosis/non osteoporosis)
Time frame: At a time following the participant having had a chest x-ray and DXA scan within 6 months of each other
Device output against the lowest DXA as measured by sensitivity, specificity, and area under the ROC curve (AUC)
2 secondary outcomes
Three class bone status classification (osteoporosis/osteopenia/normal)
Time frame: At a time following the participant having had a chest x-ray and DXA scan within 6 months of each other
Classification for osteoporosis and osteopenia
Time frame: At a time following the participant having had a chest x-ray and DXA scan within 6 months of each other
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 23 Oct 2026.
- Individual participant dataSharing planned: No. No IPD will be shared. The trial data is proprietary and part of a product development program.
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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.
Jacob J Visser, Musculoskeletal Radiologist principal investigator
Erasmus Medical Center
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoporosis, Osteopenia, run by Promedius Inc at 3 sites in 2 countries.
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 6 inclusion and 15 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 23 Oct 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 United Kingdom, Netherlands. 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 Jung Jinho, Ph.D. Candidate in Pharmacy (+821083113509, jhjung@promedius.ai), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Two class bone status classification (osteoporosis/non osteoporosis) (time frame: At a time following the participant having had a chest x-ray and DXA scan within 6 months of each other). 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 23 Oct 2026.