OsteoporosisNCT05714787
Opportunistic Screening for Osteoporotic Vertebral Fractures in Patients With Diffuse Interstitial Lung Disease
An observational study of Osteoporosis and Interstitial Lung Disease, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
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). Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Osteoporosis, Interstitial Lung Disease, Vertebral Fracture
- What is being tested?
- Chest CT Scan examination
- How many people
- 202 participants
- Where
- 1 siteFrance
- Study dates
- 23 Jan 2017to 1 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Absence of a thoracic CT scan performed at Nice center university hospital
- Secondary vertebral fracture
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Osteoporosis, Interstitial Lung Disease, Vertebral Fracture
- Being tested
- Chest CT Scan examination
- Medical subject headings
- Osteoporosis, Lung Diseases, Interstitial, Spinal Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chest CT Scan examinationOther
Double examination of chest CT scan on sagittal section after multiplanar reconstruction
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 years
Secondary outcomes (2)
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.
Measured: 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
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2023
- Study start23 Jan 2017
- Primary completion1 Jan 2023
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05714787
- Sponsor's protocol ID
- 23Rhumato01
- Status last verified
- Mar 2025
- First submitted
- 20 Jan 2023
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: not scheduled
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opportunistic Screening for Vertebral Osteoporotic Fractures on Chest CT Scan Evaluation of Patients With Interstitial Lung Disease : COLIBRI Based Retrospective Study
- ClinicalTrials.gov ID
- NCT05714787
- Acronym / sponsor ID
- 23Rhumato01
- Conditions
- Osteoporosis, Interstitial Lung Disease, Vertebral Fracture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 23 Jan 2017 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 6 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Absence of a thoracic CT scan performed at Nice center university hospital
- Secondary vertebral fracture
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chest CT Scan examinationDouble examination of chest CT scan on sagittal section after multiplanar reconstruction | Other | – |
Primary outcome
Presence or absence of vertebral fracture in the global cohort
Time frame: 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 secondary outcomes
Presence or absence of vertebral fracture in subgroups
Time frame: 6 years
To compare bone mineral density in Hounsfield Unit of patients with or without at least one vertebral fracture.
Time frame: 6 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
- Individual participant dataSharing planned: No. not scheduled
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoporosis and Interstitial Lung Disease, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence or absence of vertebral fracture in the global cohort (time frame: 6 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2025.