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

Osteoporosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05714787
• Other study ID #: 23Rhumato01
• Status: Active, not recruiting
• Start date: January 23, 2017
• Est. completion date: June 30, 2023

Study information

• Verified date: January 2023
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 203
• Est. completion date: June 30, 2023
• Est. primary completion date: January 5, 2023
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Interstitial Lung Disease
• Lung Diseases
• Lung Diseases, Interstitial
• Osteoporosis
• Spinal Fractures
• Vertebral Fracture

Intervention

Other:
• Chest CT Scan examination
Double examination of chest CT scan on sagittal section after multiplanar reconstruction

Locations

Country	Name	City	State
France	Chu de Nice	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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