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

March 25, 2026 updated by: Maximilian Löffler, Technical University of Munich

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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)

Study Type

Observational

Enrollment (Actual)

2799

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • München, Germany, 81675
        • Klinikum Rechts der Isar

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Consecutive patients from the local imaging database that received a CT scan including at least T6 to L4 (=baseline) and a second CT scan after at least 5 years including at least T6 to L4 (=5 years follow-up)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incident vertebral fracture
Time Frame: From enrollment to minimum 5 years follow-up
CT based detection of vertebral fractures
From enrollment to minimum 5 years follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical fragility fractures
Time Frame: From enrollment to maximum 10 years follow-up (upon availability)
Fragility fractures from medical records (retrospective)
From enrollment to maximum 10 years follow-up (upon availability)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Technical University of Munich

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 25, 2003

Primary Completion (Actual)

October 15, 2021

Study Completion (Actual)

October 15, 2021

Study Registration Dates

First Submitted

March 17, 2026

First Submitted That Met QC Criteria

March 17, 2026

First Posted (Actual)

March 23, 2026

Study Record Updates

Last Update Posted (Actual)

March 31, 2026

Last Update Submitted That Met QC Criteria

March 25, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTFU5YTUM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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