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

NCT07487688 | Completed

• 1 other identifier: CTFU5YTUM
• Study Type: observational
• Target: 2,799
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoporosis; Fracture Risk Assessment; Osteoporotic Fracture of Vertebra

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Incident vertebral fracture

  CT based detection of vertebral fractures

  From enrollment to minimum 5 years follow-up

Secondary Outcomes (1)

• Clinical fragility fractures

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

Interventions

Opportunistic osteoporosis screening DIAGNOSTIC_TEST

Automatic assessment of CT-based biomarkers of bone health

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

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

You may not qualify if:

• CT: No sagittal reformations or axial slices ≤3 mm
• No BMI data available

Sponsors & Collaborators

• Technical University of Munich: lead

Study Sites (1)

Klinikum rechts der Isar

München, 81675, Germany

Location

MeSH Terms

Conditions

Osteoporosis; Spinal Fractures

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Spinal Injuries; Back Injuries; Wounds and Injuries; Fractures, Bone

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Radiology Specialist

Study Record Dates

• First Submitted: March 17, 2026
• First Posted: March 23, 2026
• Study Start: February 25, 2003
• Primary Completion: October 15, 2021
• Study Completion: October 15, 2021
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)