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Five-Year CT Follow-Up of Vertebral Fracture Risk Using Opportunistic Osteoporosis Screening

CTFU: Five-Year Computed Tomography Follow-Up Study of Vertebral Fracture Risk Using Opportunistic Screening for Osteoporosis

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07487688
Enrollment
2799
Registered
2026-03-23
Start date
2003-02-25
Completion date
2021-10-15
Last updated
2026-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fracture Risk Assessment, Osteoporosis, Osteoporotic Fracture of Vertebra

Keywords

Osteoporosis, Opportunistic Screening, Vertebral Fractures, Computed Tomography, Bone Mineral Density, Fracture Risk Assessment

Brief summary

This study evaluates whether opportunistic osteoporosis screening using routinely acquired computed tomography (CT) scans improves fracture risk prediction compared with guideline-recommended FRAX-based screening from age 50. In current practice, few high-risk individuals identified by FRAX actually receive confirmatory dual-energy X-ray absorptiometry (DXA), despite the growing health and economic burden of osteoporotic fractures. Volumetric bone mineral density (vBMD) and CT-based detection of vertebral fractures can be extracted from existing CT images obtained for other indications, offering a non-invasive way to capture key determinants of fracture and mortality risk, including low BMD, age, and prevalent fractures. The trial therefore compares the diagnostic performance of FRAX major osteoporotic fracture risk versus CT-derived vBMD and CT-identified vertebral fractures for predicting incident vertebral fractures in older adults.

Detailed description

Primary objective: To assess the predictive performance of opportunistic volumetric bone mineral density (vBMD) from routine thoracoabdominal CT scans for incident vertebral fractures over 5 years or longer. Secondary objectives: * To compare the performance of vBMD to predict incident vertebral fractures with other predictors, including demographic and clinical risk factors, FRAX algorithm scores for 5-year risk of major osteoporotic fractures (MOF), prevalent vertebral fractures, and prevalent clinical fractures, as well as combinations of these predictors. * To stratify the analyses based on age decades and sex. * To compare the predictive performance between CT scans with and without administration of i.v. contrast medium. * To compare the predictive performance of vBMD (using asynchronous calibration) with Hounsfield units * To describe the prevalence and incidence (in fractures per person-years) of the study population * Assessment of the impact of a preventive treatment of patients at high risk of fracture in terms of the number of avoided fractures (simulation study)

Interventions

DIAGNOSTIC_TESTOpportunistic osteoporosis screening

Automatic assessment of CT-based biomarkers of bone health

Sponsors

Technical University of Munich
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum

Inclusion criteria

* Baseline CT and 5 years follow-up CT including parts of the lumbar spine

Exclusion criteria

* CT: No sagittal reformations or axial slices ≤3 mm * CT: No inclusion of at least T6 to L4 * No BMI data available

Design outcomes

Primary

MeasureTime frameDescription
Incident vertebral fractureFrom enrollment to minimum 5 years follow-upCT based detection of vertebral fractures

Secondary

MeasureTime frameDescription
Clinical fragility fracturesFrom enrollment to maximum 10 years follow-up (upon availability)Fragility fractures from medical records (retrospective)

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 1, 2026