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

NCT05714787 | Completed

• 1 other identifier: 23Rhumato01
• Study Type: observational
• Target: 202
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoporosis; Interstitial Lung Disease; Vertebral Fracture

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Presence or absence of vertebral fracture in subgroups

  6 years

• To compare bone mineral density in Hounsfield Unit of patients with or without at least one vertebral fracture.

  6 years

Interventions

Chest CT Scan examination OTHER

Double examination of chest CT scan on sagittal section after multiplanar reconstruction

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Absence of a thoracic CT scan performed at Nice center university hospital
• Secondary vertebral fracture

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

Chu de Nice

Nice, 06000, France

Location

MeSH Terms

Conditions

Osteoporosis; Lung Diseases, Interstitial; Spinal Fractures

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Lung Diseases; Respiratory Tract 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: SPONSOR

Study Record Dates

• First Submitted: January 20, 2023
• First Posted: February 6, 2023
• Study Start: January 23, 2017
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2023
• Last Updated: April 1, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)