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Calibr-Ì: Comparative Evaluation of Phantomless Calibration Methods to Quantify Bone Mineral Density for Opportunistic Analysis of CT Scans

NCT06454617 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2025-06-10

No results posted yet for this study

Summary

Osteoporosis is a systemic disease characterized by a reduction in bone mineral density (BMD) and qualitative alteration of the skeleton, resulting in increased bone fragility and fracture risk. The epidemiological impact of osteoporosis is extremely high. Proper diagnosis and clinical management of osteoporosis are critical to reducing the incidence of fragility fractures and preventing their complications. The diagnosis is generally confirmed by instrumental analysis of bone mineral density. The standard method is X-ray bone densitometry (DXA), which allows diagnosis based on criteria defined by the World Health Organization (WHO) by virtue of the T-score. DXA is a relatively quick and inexpensive examination with low exposure to ionizing radiation. However, this method has limitations in detecting fracture risk, and in addition, not all patients are properly referred for DXA services, which, among other things, require specific criteria to be reimbursed by the National Health System. Currently, computed tomography (CT) scanning is the most widely used three-dimensional diagnostic modality in clinical practice, and the number of investigations performed in high-income countries is continuously growing. Quantitative assessment of bone mineral density by CT is possible by proper calibration of the machine for the purpose of converting the CT numbers (or Hounsfield units) measured by the scanner into BMD units.

Conditions

Interventions

OTHER

Phantom

The patients will be simultaneously scanned with a QCT phantom

Sponsors & Collaborators

  • Auckland Hospital - Greenlane Clinical Centre - National Women's Hospital

    collaborator UNKNOWN

  • Istituto Ortopedico Rizzoli

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-06
Primary Completion
2026-06-30
Completion
2026-06-30

Countries

  • Italy
  • New Zealand

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06454617 on ClinicalTrials.gov