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

Recruitingn/aAges 18 Years - anyAllIstituto Ortopedico Rizzoli
NCT06454617 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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,

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📋 Eligibility rules (as published)
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.
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What it tests

  • Phantom
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Where

2 sites
The Rizzoli Orthopaedic Institute
Bologna, Italy
Auckland Hospital - Greenlane Clinical Centre - National Women's Hospital
Auckland, New Zealand
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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