Skip to main content
OpenTrials
Completed

NCT Number: NCT07487688

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

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.

Completed

Looking for future studies?

Notify Me

Key information

About this study

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)

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Opportunistic osteoporosis screening

Diagnostic Test

Automatic assessment of CT-based biomarkers of bone health

Primary outcomes

  1. Incident vertebral fracture

    Time frame: From enrollment to minimum 5 years follow-up

    CT based detection of vertebral fractures

Secondary outcomes

  1. Clinical fragility fractures

    Time frame: From enrollment to maximum 10 years follow-up (upon availability)

    Fragility fractures from medical records (retrospective)

Sponsors and collaborators

Lead sponsor

Technical University of Munich

Other

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2021
Study completion
2021
First posted
Mar 23, 2026
Registry last updated
Mar 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.