Opportunistic Screening for Osteoporotic Vertebral Fractures in Patients With Diffuse Interstitial Lung Disease

Sponsor
Centre Hospitalier Universitaire de Nice (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05714787
Collaborator
(none)
203
1
77.2
2.6

Study Details

Study Description

Brief Summary

It is well known that some chronic respiratory pathologies such as asthma or chronic obstructive pulmonary disease (COPD) are associated with an increased risk of osteoporosis, due to the pathology itself and the therapies implemented (per-os or inhaled corticosteroids). Osteoporosis leads to an increased risk of fragility fracture, with an increased morbidity and mortality associated with severe fractures such as vertebral fractures. Also, osteoporotic vertebral fractures often occur at the thoracolumbar hinge, resulting in worsening of the thoracic kyphosis. However, to the best of our knowledge, the prevalence of osteoporotic vertebral fractures measured by CT scan in patients with interstitial lung disease (ILD) is not known. For these patients who already have impaired respiratory function, the appearance of vertebral fractures could impact their management and worsen their prognosis (additional restrictive syndrome, difficulties in analgesics management because of respiratory contraindications, difficulties in wearing a corset, etc...). In this context, it appears interesting to define the prevalence of osteoporosis and osteoporotic vertebral fractures at the thoracic spine and the thoraco-lumbar hinge in a population of patients followed for ILD. So, the main objective of this study is to describe the prevalence of vertebral osteoporotic fractures in an overall cohort of patients with ILD.

Condition or Disease Intervention/Treatment Phase
  • Other: Chest CT Scan examination

Study Design

Study Type:
Observational
Actual Enrollment :
203 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Opportunistic Screening for Vertebral Osteoporotic Fractures on Chest CT Scan Evaluation of Patients With Interstitial Lung Disease : COLIBRI Based Retrospective Study
Actual Study Start Date :
Jan 23, 2017
Actual Primary Completion Date :
Jan 5, 2023
Anticipated Study Completion Date :
Jun 30, 2023

Outcome Measures

Primary Outcome Measures

  1. Presence or absence of vertebral fracture in the global cohort [6 years]

    a vertebral fracture is considered if a decrease in height of the vertebral plateau by more than 20 % on an examination of chest CT scan on sagittal section after multiplanar reconstruction is observed.

Secondary Outcome Measures

  1. Presence or absence of vertebral fracture in subgroups [6 years]

    a vertebral fracture is considered if a decrease in height of the vertebral plateau by more than 20 % on an examination of chest CT scan on sagittal section after multiplanar reconstruction is observed.

  2. To compare bone mineral density in Hounsfield Unit of patients with or without at least one vertebral fracture. [6 years]

    Bone mineral density in hounsfield unit is evaluated by measuring trabecular attenuation in an ovoid region of interest on axial T12 section

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 95 Years
Sexes Eligible for Study:
All
Inclusion Criteria:
  • Patients older than 18 years old ;

  • Patients included in the COLIBRI database for ILD between January 2017 and January 2023 ;

  • Patients with a chest CT scan performed at the Nice center university hospital.

Exclusion Criteria:
  • Absence of a thoracic CT scan performed at Nice center university hospital

  • Secondary vertebral fracture

Contacts and Locations

Locations

Site City State Country Postal Code
1 Chu de Nice Nice France 06000

Sponsors and Collaborators

  • Centre Hospitalier Universitaire de Nice

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT05714787
Other Study ID Numbers:
  • 23Rhumato01
First Posted:
Feb 6, 2023
Last Update Posted:
Feb 6, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 6, 2023