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NCT Number: NCT07421713

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

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.

Recruiting

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Erasmus University Medical Center Rotterdam,, Rotterdam, Netherlands

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • 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

Treatment and study plan

Osteo Signal

Device

Artificial Intelligence (AI) software

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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

    Device output against the lowest DXA as measured by area under the ROC curve (AUC), overall per cent agreement, and weighted Cohen's kappa

  2. 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

    Positive predictive value (PPV) and negative predictive value (NPV) for osteoporosis and osteopenia classifications

Study contacts

Contact information is provided by the study sponsor or research team.

Jung Jinho

CONTACT

[email protected]

+82 1083113509

Kim Bensalem

CONTACT

[email protected]

+447885369062

Sponsors and collaborators

Lead sponsor

Promedius Inc

Industry

Registry information

Official study 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.

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 19, 2026
Registry last updated
Feb 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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