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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Italy
The Rizzoli Orthopaedic Institute
RECRUITING
Bologna
New Zealand
Auckland Hospital - Greenlane Clinical Centre - National Women's Hospital
NOT_YET_RECRUITING
Auckland
Contact Information
Primary
Alberto Bazzocchi, MD
alberto.bazzocchi@ior.it
051636
Backup
Rebecca Sassi, MSc
rebecca.sassi@ior.it
051636
Time Frame
Start Date: 2024-06-06
Estimated Completion Date: 2026-06
Participants
Target number of participants: 100
Treatments
Experimental
Patients that require a TC scan.
Related Therapeutic Areas
Sponsors
Leads: Istituto Ortopedico Rizzoli
Collaborators: Auckland Hospital - Greenlane Clinical Centre - National Women's Hospital

This content was sourced from clinicaltrials.gov