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RecruitingNCT06449742Updated Apr 8, 2026

A Prospective Observational Study of Artificial Intelligence Morphometric Evaluation of Vertebral Fractures

An observational study in Vertebral Fracture and Osteoporosis, sponsored by IRCCS San Raffaele. Recruiting at 1 site in Italy. Open to male participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-04-08.

Sponsored by IRCCS San Raffaele · Observational

From the registry’s dates

  • Started Mar 2025; still recruiting 1 year 7 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
250
Ages
50 Years and older
Sex
Male
01

Study summary

The study will be conducted as a monocentric observational prospective study design wants to evaluate the prevalence of vertebral fractures in the cohort of patients that perform a chest-abdomen CT for medical indication other than osteometabolic pathologies.

Read the detailed description

This study aimed to evaluate the prevalence of vertebral fractures in a cohort of patients that perform a chest-abdomen CT for medical indication other than osteometabolic pathologies.It is estimated that 250 patients will be enrolled (Patients will be enrolled in retrospective and prospective way between 01/03/2025 and 28/02/2026. The presence of one or more vertebral fractures will be evaluated through the radiological medical assessment with automatic 3D reconstruction of the thoracic and lumbar spine and by application of the AI software NanoxAIHealthVCF NANO-X IMAGING LTD on abdomen-chest CT studies.

Clinical, anthropometric, and anamnestic data will be collected from patients undergoing CT assessments. These data will be collected on the day of the radiological examination.

There will be only one evaluation at the time of the CT scan. Only in case of fracture detection, via radiological medical assessment and/or via AI software, the patient will be subsequently evaluated in the Endocrinology Unit as for standard of care.

02

Conditions studied

  • Vertebral Fracture
  • Osteoporosis
03

In context

Spinal Fractures

164 studies on the registry are indexed under Spinal Fractures; 29 are open to participants now.

This study's planned enrollment of 250 is above the median of 130 across 57 observational studies indexed under Spinal Fractures.

Browse Spinal Fractures studies →

Lead sponsor

IRCCS San Raffaele is the lead sponsor of 443 studies on the registry; 234 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
50 Years and older
Sexes eligible
Male
Sampling method
Non-probability sample

Study population

Male patients, with an age ≥ 50 years old, that perform CT scan, without osteo-metabolic conditions.

Inclusion criteria

  1. Male subjects
  2. Age ≥ 50 years
  3. Clinical and medical history data available at abdomen-chest CT evaluation
  4. Signature of informed consent to the study

Exclusion criteria

Exclusion Criteria:

  1. Hospitalized patients
  2. Patients known to have osteo-metabolic diseases.
  3. with primary and/or acquired immunodeficiency states, and/or severe impairment of general clinical condition (e.g. metastatic neoplasms; immunosuppressive therapies; worsening/reacute/compensated chronic diseases; moderate-severe renal failure)
  4. Patients unable to understand and sign the Informed Consent.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
250 participants (estimated)
Patient registry
No

Groups and cohorts

  • Patients undergoing to CT abdomen-chest

    Patients undergoing to CT abdomen-chest study at the UO of Radiology of the IRCCS San Raffaele Hospital for clinical indications not related to osteo-metabolic pathology. Patients will be evaluated for vertebral fractures both through the radiological medical evaluation with automatic 3D reconstruction of the thoracic and lumbar spine and through application of the AI software NanoxAIHealthVCF, NANO-X IMAGING LTD on abdomen-chest CT studies.

    Diagnostic Test: AI software and automatic 3D reconstruction

Interventions

  • Diagnostic testAI software and automatic 3D reconstruction

    Radiological medical evaluation with automatic 3D reconstruction of the thoracic and lumbar spine and through application of the AI software NanoxAIHealthVCF, NANO-X IMAGING LTD on abdomen-chest CT studies.

06

What researchers measure

Primary outcomes

  1. Number of fractures detected with CT scans trough AI software and 3D reconstruction

    The UO of Endocrinology, in collaboration with the UO of Radiology of the IRCCS San Raffaele Hospital, proposes to assess the prevalence of vertebral fractures prospectively in the population afferent to our hospital to perform abdomen-chest CT studies through the radiological medical evaluation with automatic 3D reconstruction of the thoracic and lumbar spine and the application of the AI software cNanoxAIHealthVCF, NANO-X IMAGING LTD.

    Time frame: from 01/03/2025 to 28/02/2026

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06449742
Lead sponsor
IRCCS San Raffaele
Responsible party
Luigi Di Filippo (Medical Physician Specialist in Endocrinology, IRCCS San Raffaele) — Principal investigator
First posted
Jun 10, 2024
Start date
Mar 1, 2025
Primary completion
Mar 30, 2026
Completion
Mar 1, 2027 (estimated)
Last update
Apr 8, 2026

Study contacts

Luigi Di Filippo, MD
Contact
difilippo.luigi@hsr.it
0226435062
Gabriela Felipe, CRN
Contact
felipe.gabriela@hsr.it
0226435062
Andrea Giustina, MD
principal investigator · IRCCS Ospedale San Raffaele and Vita-Salute San Raffaele University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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