NCT06454617 Calibr-Ì: Comparative Evaluation of Phantomless Calibration Methods to Quantify Bone Mineral Density for Opportunistic Analysis of CT Scans
| NCT ID | NCT06454617 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Istituto Ortopedico Rizzoli |
| Condition | Osteoporosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-06-06 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2024-06-06 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06454617 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Osteoporosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06454617 currently recruiting?
Yes, NCT06454617 is actively recruiting participants. Contact the research team at alberto.bazzocchi@ior.it for enrollment information.
Where is the NCT06454617 trial being conducted?
This trial is being conducted at Bologna, Italy, Auckland, New Zealand.
Who is sponsoring the NCT06454617 clinical trial?
NCT06454617 is sponsored by Istituto Ortopedico Rizzoli. The trial plans to enroll 100 participants.