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NCT Number: NCT06454617

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Rizzoli Orthopaedic Institute, Bologna, Bo, Italy

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Both sexes.
  • All ethnicities.
  • Age equal or above 18 years.
  • Any clinical indication (no specific pathology is required) for a CT scan of the lumbosacral spine or abdomen in which the entire lumbar spine (L1 to L5), paravertebral muscles, abdominal aorta, and subcutaneous adipose tissue are visible.
  • Ability to give informed consent.

Exclusion criteria

  • General contraindications to CT examination, including pregnancy or body weight/size exceeding scanner limits.
  • Severe degenerative manifestations of the lumbosacral spine.
  • Severe scoliosis of the lumbosacral spine.
  • Surgical hardware that prevents adequate CT scanning.
  • Oncologic pathology in progress or in recent history.
  • Any other situation deemed incompatible with the study by the designated physician or investigator.

Treatment and study plan

Phantom

Other

The patients will be simultaneously scanned with a QCT phantom

Primary outcomes

  1. Comparison of different internal calibration methods

    Time frame: At baseline (Day 0)

    Compare the different methods of internal or phantomless calibration described in the literature with synchronous and asynchronous calibration in a population of patients undergoing CT scans that include the lumbar spine to assess their feasibility.

Secondary outcomes

  1. Definition of performance of internal calibration methods

    Time frame: At baseline (Day 0)

    Define the performance of various internal or phantomless calibration methods for the purpose of identifying the most appropriate and reliable technique.

  2. Optimization of existing internal calibration methods

    Time frame: Through study completion, up to 2 years

    Optimize existing internal calibration methods, and eventually define a new phantomless targeted calibration protocol based on the results of the study.

Study contacts

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

Alberto Bazzocchi, MD

CONTACT

[email protected]

051636 ext. 6028

Rebecca Sassi, MSc

CONTACT

[email protected]

051636 ext. 6028

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Collaborators

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

Registry information

Official study title

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

Acronym: Calibr-Ì

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 12, 2024
Registry last updated
Jun 10, 2025

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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