NCT06454617Recruiting
Calibr-Ì: Comparative Evaluation of Phantomless Calibration Methods to Quantify Bone Mineral Density for Opportunistic Analysis of CT Scans
Comparative Evaluation of Phantomless Calibration Methods to Quantify Bone Mineral Density for Opportunistic Analysis of CT Scans
Source: ClinicalTrials.gov · Last updated 10 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 100 (estimated)
- First submitted
- 6 Jun 2024
- Start date
- 6 Jun 2024
- Primary completion date
- Jun 2026
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Diseases
- Osteoporosis
- NCT number
- NCT06454617
What you commit to
- Study type: Observational
- Planned participants: 100
- From 6 Jun 2024 to the primary completion date, Jun 2026
- 2 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Surgical hardware that prevents adequate CT scanning.
Other
- 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.
- Oncologic pathology in progress or in recent history.
- Any other situation deemed incompatible with the study by the designated physician or investigator.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Rizzoli Orthopaedic Institute Coordinator of this site? Confirm its status | Bologna | Italy | Recruiting |
| Auckland Hospital - Greenlane Clinical Centre - National Women's Hospital Coordinator of this site? Confirm its status | Auckland | New Zealand | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.