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.

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 Overview

• Status: Recruiting
• Conditions: Osteoporosis, Osteopenia
• Intervention / Treatment: Device: Osteo Signal

• Study Type: Observational
• Enrollment (Estimated): 595

Contacts and Locations

• Study Contact: Name: Kim Bensalem; Phone Number: +447885369062; Email: kim@medilife.net
• Study Contact Backup: Name: Jung Jinho; Phone Number: +82 1083113509; Email: jhjung@promedius.ai

Study Locations

• Netherlands
  • Rotterdam, Netherlands, 3015 GD
    • Not yet recruiting
    • Erasmus University Medical Center Rotterdam,
    • Principal Investigator: Jacob J Visser, Musculoskeletal Radiologist
• United Kingdom
  • London, United Kingdom, E1 4DG
    • Recruiting
    • Barts Health NHS Trust
    • Principal Investigator: Giuseppe Ruocco
  • Essex
    • Westcliff-on-Sea, Essex, United Kingdom, SS0 0RY
      • Not yet recruiting
      • Mid and South Essex NHS Foundation Trust
      • Principal Investigator: Anupama C Nandagudi, Consultant Rheumatologist

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients selected hospitals in the Netherlands and UK that have previously had chest x-rays and DXA scans

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	At a time following the participant having had a chest x-ray and DXA scan within 6 months of each other

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	At a time following the participant having had a chest x-ray and DXA scan within 6 months of each other

Collaborators and Investigators

• Sponsor: Promedius Inc
• Investigators: Principal Investigator: Jacob J Visser, Musculoskeletal Radiologist, Erasmus Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2026
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: February 12, 2026
• First Submitted That Met QC Criteria: February 12, 2026
• First Posted (Actual): February 19, 2026

Study Record Updates

• Last Update Posted (Actual): February 19, 2026
• Last Update Submitted That Met QC Criteria: February 12, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Osteoporosis; Bone Diseases, Metabolic
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Osteoporosis; Bone Diseases, Metabolic
• Other Study ID Numbers: CIP-OSTEO3-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No IPD will be shared. The trial data is proprietary and part of a product development program.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No