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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

Sponsor: Promedius Inc

NCT ID: NCT07421713

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Health checks and monitoring — no treatment given
Type of study
Observational (no treatment given)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Osteo Signal (device)
How long the study runs
Study runs about 1 month (dates as stated)
About the drug or intervention
Osteo Signal — device: Artificial Intelligence (AI) software
Patient visit burden
Not specified by the sponsor

In plain English

This study, run by Promedius Inc, is testing whether artificial intelligence (AI) software can use chest X-rays to spot signs of osteoporosis (weak or thinning bones) as well as the standard DXA scan does. It involves people aged 50 and over who have had both a chest X-ray and a DXA scan. The results of the two methods will be compared.

Who can take part

  • Age 50 or older when the chest X-ray was taken
  • Has had a PA (front-facing) chest X-ray and a DXA bone scan, both done within 6 months of each other, with a valid T-score from the DXA scan
  • Both scans were done on or after 1 January 2010
  • Sex and age details are available on hospital records or the imaging system (PACS)
  • Has not opted out of their confidential data being used for research

Who may not be able to

  • Scans that are poor quality or incomplete, in the wrong format, or where the chest X-ray was more than 6 months before or after the DXA scan
  • Already diagnosed with osteoporosis (a T-score of -2.5 or lower) or taking osteoporosis medicines before or around the time of the study scans
  • Diagnosed with any metabolic bone disease before, or up to 3 months after, the DXA scan used in the study
  • Major chest wall or spinal problems, such as severe curvature of the spine, chest wall deformities affecting more than 30% of the chest area, metal implants from chest or spine surgery, or lung problems covering more than 30% of the bones seen on the X-ray

What taking part involves

  • • No new treatment is given — the study looks at scans and data that have already been collected

Time commitment: No new scans or visits are described — the study uses chest X-rays and DXA scans already performed on or after 1 January 2010.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Observing health over time
Ages
50 Years and over
Who
All
Number of participants
595
Started
2026-02-10
Last checked
2026-02

Plain English Summary

What is this study?

  • • Testing a new treatment for osteoporosis, osteopenia
  • • Clinical study - 595 participants
  • • 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

Who can take part?

  • • Ages 50 Years and over
  • • Diagnosed with osteoporosis, osteopenia

Where?

  • • Westcliff-on-Sea - Mid and South Essex NHS Foundation Trust
  • • London - Barts Health NHS Trust

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Osteoporosis, Osteopenia

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 50 Years and over
  • Who can join: All genders

What 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...
  • ✓Available X-ray and DXA scans performed on or after 01-Jan-2010.

Who cannot take part

  • ✗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...
  • ✗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.
See the full criteria
Inclusion Criteria: 1. Age ≥50 years at the time of chest X-ray 2. Availability of 1. Posteroanterior (PA) Chest X-ray and 2. 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 3. Available X-ray and DXA scans performed on or after 01-Jan-2010. 3. Complete metadata (sex and age) available on PACS or hospital records. Exclusion Criteria: 1. Non-diagnostic Quality or Incomplete Imaging of: 1. DXA scan inadequacy: Missing T-score from a technically inadequate scan. 2. PA Chest X-ray technical inadequacy: Non-PA projection, significant motion artefacts, inadequate visualisation of thoracic structures, or missing DICOM metadata. 3. Image format incompatibility: Non-DICOM format or corrupted image files that would prevent AI analysis 4. PA Chest X-ray \> ±6 months from the date of the DXA scan. 2. Previous diagnosis or treatment of Osteoporosis prior to the DXA scan used in the Study. 1. 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. 2. Current or recent anti-osteoporotic medications for 3 months (91 days) continuously prior to the Chest x-ray used in the Study. 3. Diagnosis of any metabolic bone disease prior to the DXA scan used in the study. 4. Diagnosis of metabolic bone disease other than Osteoporosis or Osteopenia, up to a maximum of 3 months (91 days) after the DXA scan. 5. Major Chest Wall or Spinal Deformities, including but not limited to: 1. Severe structural deformities: Thoracic scoliosis with Cobb angle \>40°, severe kyphosis, or chest wall deformities (pectus excavatum/carinatum) affecting \>30% of the thoracic cage. 2. Surgical hardware: Previous thoracic/spinal surgery with metallic implants obscuring anatomical landmarks required for AI analysis. 3. Pathological conditions: Extensive pulmonary consolidation, pleural effusion, lesions or masses obscuring \>30% of thoracic skeletal structures 6. Subject has opted out of confidential data being used for research purposes

Where Is This Study? (2 UK sites)

Mid and South Essex NHS Foundation Trust

Westcliff-on-Sea SS0 0RY, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)
Anupama C Nandagudi, Consultant RheumatologistPrincipal Investigator

Barts Health NHS Trust

London E1 4DG, United Kingdom

Recruiting
Site contact (verified)
Giuseppe RuoccoPrincipal Investigator

How to Get in Touch

Kim Bensalem

Sponsor contact

CONTACT

+447885369062 kim@medilife.net

Jung Jinho

Sponsor contact

CONTACT

+82 1083113509 jhjung@promedius.ai
Data sourced from ClinicalTrials.gov · Last verified: 2026-02