NCT07306858

Brief Summary

Osteoporotic vertebral compression fractures are common in older adults and may present as either acute or chronic fractures. Correctly distinguishing acute from chronic fractures is clinically important because treatment strategies and management decisions differ depending on fracture chronicity. However, differentiating acute and chronic osteoporotic vertebral compression fractures based on imaging findings alone can be challenging in routine clinical practice. This retrospective study aims to develop an intelligent diagnostic system based on computed tomography (CT) images to differentiate acute and chronic osteoporotic vertebral compression fractures. Clinical and imaging data from patients diagnosed with osteoporotic vertebral compression fractures will be collected from the First Affiliated Hospital of Chongqing Medical University and an additional medical center. A deep learning model will be trained to automatically analyze CT images and classify fractures as acute or chronic. The results of this study may help improve the accuracy and efficiency of fracture chronicity assessment using CT images and provide supportive information for clinical decision-making regarding treatment selection in patients with osteoporotic vertebral compression fractures.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
276

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 15, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

December 16, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 29, 2025

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 29, 2025

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2026

Completed
Last Updated

December 31, 2025

Status Verified

December 1, 2025

Enrollment Period

13 days

First QC Date

December 15, 2025

Last Update Submit

December 26, 2025

Conditions

Keywords

Osteoporotic vertebral compression fractureDeep learning

Outcome Measures

Primary Outcomes (1)

  • Diagnostic performance of the deep learning model for differentiating acute and chronic osteoporotic vertebral compression fractures

    The diagnostic performance of the deep learning model in differentiating acute and chronic osteoporotic vertebral compression fractures based on CT images, evaluated using the area under the receiver operating characteristic curve (AUC).

    At the time of image analysis

Study Arms (2)

Acute Osteoporotic Vertebral Compression Fracture Group

Patients diagnosed with acute osteoporotic vertebral compression fractures based on clinical assessment and imaging findings.

Other: No Intervention (Observational Study)

Chronic Osteoporotic Vertebral Compression Fracture Group

Patients diagnosed with chronic osteoporotic vertebral compression fractures based on clinical assessment and imaging findings.

Other: No Intervention (Observational Study)

Interventions

This is a retrospective observational study. No therapeutic, diagnostic, or preventive intervention is assigned as part of the study. All analyses are based on previously acquired clinical and imaging data.

Acute Osteoporotic Vertebral Compression Fracture GroupChronic Osteoporotic Vertebral Compression Fracture Group

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population consists of adult patients aged 40 years or older who were diagnosed with osteoporotic vertebral compression fractures and underwent CT and MRI examinations at the participating centers.

You may qualify if:

  • Patients diagnosed with osteoporotic vertebral compression fractures.
  • Patients who underwent both CT and MRI examinations of the spine, with an interval of less than 2 weeks between examinations.
  • Availability of complete CT and MRI imaging data in DICOM format.
  • Availability of complete clinical information, including age, sex, and dual-energy X-ray absorptiometry (DXA) results.
  • Age 50 years or older at the time of imaging.

You may not qualify if:

  • Vertebral compression fractures caused by infection or malignancy.
  • Presence of foreign materials, including bone cement or metallic hardware.
  • Poor image quality or significant imaging artifacts that affect analysis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400016, China

Location

MeSH Terms

Interventions

Observation

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 15, 2025

First Posted

December 29, 2025

Study Start

December 16, 2025

Primary Completion

December 29, 2025

Study Completion

January 15, 2026

Last Updated

December 31, 2025

Record last verified: 2025-12

Locations