Ignite Creation Date:
2024-05-06 @ 3:47 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04757714
Status:
WITHDRAWN
Last Update Posted:
2024-01-10
First Post:
2021-02-12
Brief Title:
Thoracic Kyphosis and Osteoporosis Study of Their Relationship With Respiratory Functions in Chronic Obstructive Pulmonary Disease
Sponsor:
Centre Hospitalier Régional dOrléans
Organization:
Centre Hospitalier Régional dOrléans
Study Overview
Official Title:
Thoracic Kyphosis and Osteoporosis Study of Their Relationship With Respiratory Functions in Chronic Obstructive Pulmonary Disease
Status:
WITHDRAWN
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The site is no more able to conduct the study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CYPHOS
Brief Summary:
Chronic Obstructive Pulmonary Disease COPD is a condition characterized by a progressive and incompletely reversible limitation of airborne gas flow The association of co-morbidities with COPD and acute flare-ups of respiratory failure contribute to the overall severity of this disease The prevalence of COPD is high affecting up to 10 of people over the age of 40 years and causing high morbidity and mortality rates While COPD is a disease primarily affecting the lungs it is associated with many extra-pulmonary conditions including sleep apnea depression anemia chronic kidney failure wasting cardiovascular disease skeletal muscle weakness and osteoporosis OP
Detailed Description:
Osteoporosis characterized by bone quality disorders and low bone mineral density BMD leading to a high risk of fractures is common in COPD patients For example studies have reported OP rates ranging from 9 to 69 in COPD patients The explanatory factors for this low BMD are clearly multiple involving to varying degrees of importance vitamin D deficiency depression sedentary lifestyle smoking corticosteroids low lean body mass and body mass index chronic inflammation low nutritional status chronic hypoxia and hypercapnia This is why patients with COPD have a high prevalence of fractures particularly vertebral fractures VF ranging from 30 to 63 depending on the studies In these patients the existence of thoracic VF is of crucial importance as each VF is associated with a 9 decrease in the forced vital capacity of COPD patients
For these reasons the latest HAS recommendations for COPD management indicate that the risk of osteoporosis should be systematically investigated and treated HAS 2014
However the relationship between densitometric variations and the presence of thoracic VF and the prognosis and severity of the disease is not yet very clear as studies of these relationships have produced mixed results
On the other hand it is well established that patients with a recent diagnosis of COPD have a high prevalence of densitometric OPs and fractures
Thoracic kyphosis is one of the determinants of the incidence of vertebral fractures Increased thoracic kyphosis is associated with decreased physical capacity increased risk of falls and abnormal respiratory function
In addition measurement of thoracic kyphosis was previously carried out either indirectly using point coordinates recorded in a database patients were assessed in the supine position or more directly using a ruler applied against the back
For these reasons the latest HAS recommendations for COPD management indicate that the risk of osteoporosis should be systematically investigated and treated HAS 2014
However the relationship between densitometric variations and the presence of thoracic VF and the prognosis and severity of the disease is not yet very clear as studies of these relationships have produced mixed results
On the other hand it is well established that patients with a recent diagnosis of COPD have a high prevalence of densitometric OPs and fractures
Thoracic kyphosis is one of the determinants of the incidence of vertebral fractures Increased thoracic kyphosis is associated with decreased physical capacity increased risk of falls and abnormal respiratory function
In addition measurement of thoracic kyphosis was previously carried out either indirectly using point coordinates recorded in a database patients were assessed in the supine position or more directly using a ruler applied against the back
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None