Clinical Trial: Prospective and Retrospective Research for the Diagnosis of Osteoporosis: Validation and Establishment of Vertebral Hounsfield Unit (Japan)

Tokyo, Aug. 31 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058939) titled 'Prospective and Retrospective Research for the Diagnosis of Osteoporosis: Validation and Establishment of Vertebral Hounsfield Unit' on Aug. 30.

Study Type: Observational

Primary Sponsor: Institute - Osaka Metropolitan University

Condition: Condition - Ostoporosis Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - In this study, following the same approach used when establishing the DXA reference values (Looker A et al. Osteoporosis International 1998), bone mineral density in young adults (20 - 44 years) is calculated and used as the reference, with osteoporosis defined as -2.5 SD or below and osteopenia as between -2.5 and -1 SD. Furthermore, by prospectively following patients with lumbar CT data for four years and evaluating their fracture risk, we aim to validate the appropriateness of the cutoff values determined from these reference standards. Basic objectives2 - Efficacy

Eligibility: Age-lower limit - 20 years-old = Gender - Male and Female Key inclusion criteria - Selection Criteria 1 Patients aged 20-44 years at the time of lumbar CT imaging. Patients with CT scans that include the lumbar spine between L1-4.

Selection Criteria 2 Patients aged 50 years or older at the time of lumbar CT imaging for lumbar disease diagnosis. Patients who underwent CT examinations including the lumbar spine between L1-L4. Patients with DXA data obtained within 6 months of the lumbar CT imaging date at the time of lumbar disease diagnosis. Patients with spinal X-rays available at the 2-year point within 6 months and 4-year point within 1 year from the lumbar CT imaging date at the time of lumbar disease diagnosis. Key exclusion criteria - Patients suspected of having scoliosis 10 or more degrees or secondary osteoporosis such as long-term steroid use, hyperparathyroidism, hyperthyroidism, hypogonadism, Cushing syndrome, diabetes, chronic kidney disease, chronic obstructive pulmonary disease, etc.

Patients who have undergone spinal fusion surgery. Patients suspected of having infection or tumor. Target Size - 2800

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 07 Month 10 Day Anticipated trial start date - 2025 Year 08 Month 31 Day Last follow-up date - 2029 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067332

Disclaimer: Curated by HT Syndication.