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

Opportunistic Screening for Vertebral Osteoporotic Fractures on Chest CT Scan Evaluation of Patients With Interstitial Lung Disease : COLIBRI Based Retrospective Study

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Osteoporosis; Interstitial Lung Disease; Vertebral Fracture
• Intervention / Treatment: Other: Chest CT Scan examination

• Study Type: Observational
• Enrollment (Actual): 203

Contacts and Locations

Study Locations

• France
  • Nice, France, 06000
    • CHU de Nice

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 95 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients are from a cohort data base named COLIBRI which collected date about with intersititial lung disease, recruited in Pneumology Department in Centre hospitalier universitaire de Nice.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence or absence of vertebral fracture in the global cohort	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.	6 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence or absence of vertebral fracture in subgroups	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.	6 years
To compare bone mineral density in Hounsfield Unit of patients with or without at least one vertebral fracture.	Bone mineral density in hounsfield unit is evaluated by measuring trabecular attenuation in an ovoid region of interest on axial T12 section	6 years

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 23, 2017
• Primary Completion (ACTUAL): January 5, 2023
• Study Completion (ANTICIPATED): June 30, 2023

Study Registration Dates

• First Submitted: January 20, 2023
• First Submitted That Met QC Criteria: February 2, 2023
• First Posted (ACTUAL): February 6, 2023

Study Record Updates

• Last Update Posted (ACTUAL): February 6, 2023
• Last Update Submitted That Met QC Criteria: February 2, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Respiratory Tract Diseases; Wounds and Injuries; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Spinal Injuries; Back Injuries; Lung Diseases; Fractures, Bone; Osteoporosis; Lung Diseases, Interstitial; Spinal Fractures
• Other Study ID Numbers: 23Rhumato01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: not scheduled

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No