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Search / Trial NCT06449742

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

Launched by IRCCS SAN RAFFAELE · Jun 7, 2024

Trial Information

Current as of July 23, 2025

Not yet recruiting

Keywords

ClinConnect Summary

This clinical trial is looking to understand how common vertebral fractures (breaks in the spine) are in men aged 50 and older who are undergoing a chest and abdomen CT scan for reasons not related to bone health. The researchers will use artificial intelligence (AI) to help evaluate the CT images for any signs of these fractures. The goal is to gather information that could help improve how we diagnose and treat patients with osteoporosis, a condition that weakens bones.

To be eligible for this study, participants must be male, at least 50 years old, and have their medical history available for review during the CT scan. It's important to note that patients who are currently hospitalized, have known bone diseases, or have serious health issues will not be included in the study. If someone qualifies and decides to participate, they will provide informed consent, which means they understand the study and agree to take part. This trial is not yet recruiting participants, but it will provide valuable insights into spinal health in older men.

Gender

MALE

Eligibility criteria

  • 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:
  • 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.

About Irccs San Raffaele

IRCCS San Raffaele is a prestigious research hospital and clinical trial sponsor based in Milan, Italy, renowned for its commitment to advancing medical science through innovative research and high-quality patient care. As an Institute for Research and Healthcare, it specializes in a wide range of therapeutic areas, including oncology, neurology, and cardiology, and is dedicated to translating scientific discoveries into effective clinical practices. With a multidisciplinary team of experts and state-of-the-art facilities, IRCCS San Raffaele plays a pivotal role in conducting rigorous clinical trials that contribute to the development of novel treatments and improve patient outcomes globally.

Locations

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported