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| Name | Class |
|---|---|
| Auckland Hospital - Greenlane Clinical Centre - National Women's Hospital | UNKNOWN |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Patients that require a TC scan. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phantom | Other | The patients will be simultaneously scanned with a QCT phantom |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of different internal calibration methods | 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. | At baseline (Day 0) |
| Measure | Description | Time Frame |
|---|---|---|
| Definition of performance of internal calibration methods | Define the performance of various internal or phantomless calibration methods for the purpose of identifying the most appropriate and reliable technique. | At baseline (Day 0) |
| Optimization of existing internal calibration methods |
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Inclusion Criteria:
Exclusion Criteria:
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The study will involve a population of patients undergoing CT scans including the lumbar spine at the Diagnostic and Interventional Radiology Unit of each participating center. In CT scans requiring the administration of contrast medium, only the non-contrast-enhanced images will be considered.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alberto Bazzocchi, MD | Contact | 051636 | 6028 | alberto.bazzocchi@ior.it |
| Rebecca Sassi, MSc | Contact | 051636 | 6028 | rebecca.sassi@ior.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Rizzoli Orthopaedic Institute | Recruiting | Bologna | Bo | 40136 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27339372 | Result | Rossini M, Adami S, Bertoldo F, Diacinti D, Gatti D, Giannini S, Giusti A, Malavolta N, Minisola S, Osella G, Pedrazzoni M, Sinigaglia L, Viapiana O, Isaia GC. Guidelines for the diagnosis, prevention and management of osteoporosis. Reumatismo. 2016 Jun 23;68(1):1-39. doi: 10.4081/reumatismo.2016.870. | |
| 35079919 | Result |
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| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D019047 | Phantoms, Imaging |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
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Optimize existing internal calibration methods, and eventually define a new phantomless targeted calibration protocol based on the results of the study. |
| Through study completion, up to 2 years |
| Auckland Hospital - Greenlane Clinical Centre - National Women's Hospital | Not yet recruiting | Auckland | New Zealand |
|
| Willers C, Norton N, Harvey NC, Jacobson T, Johansson H, Lorentzon M, McCloskey EV, Borgstrom F, Kanis JA; SCOPE review panel of the IOF. Osteoporosis in Europe: a compendium of country-specific reports. Arch Osteoporos. 2022 Jan 26;17(1):23. doi: 10.1007/s11657-021-00969-8. |
| 26277853 | Result | Engelke K, Lang T, Khosla S, Qin L, Zysset P, Leslie WD, Shepherd JA, Shousboe JT. Clinical Use of Quantitative Computed Tomography-Based Advanced Techniques in the Management of Osteoporosis in Adults: the 2015 ISCD Official Positions-Part III. J Clin Densitom. 2015 Jul-Sep;18(3):393-407. doi: 10.1016/j.jocd.2015.06.010. |
| 32059948 | Result | Michalski AS, Besler BA, Michalak GJ, Boyd SK. CT-based internal density calibration for opportunistic skeletal assessment using abdominal CT scans. Med Eng Phys. 2020 Apr;78:55-63. doi: 10.1016/j.medengphy.2020.01.009. Epub 2020 Feb 12. |
| D009750 |
| Nutritional and Metabolic Diseases |