Clinical Trials Directory

Trials / Withdrawn

WithdrawnNCT04757714

Thoracic Kyphosis and Osteoporosis: Study of Their Relationship With Respiratory Functions in Chronic Obstructive Pulmonary Disease.

Status
Withdrawn
Phase
N/A
Study type
Interventional
Enrollment
0 (actual)
Sponsor
Centre Hospitalier Régional d'Orléans · Academic / Other
Sex
All
Age
40 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREThe high-resolution peripheral scanner (HRpQCT) of the tibia and radiusThe high-resolution peripheral scanner (HRpQCT) of the tibia and radius
PROCEDUREa low-dose imaging system exploration of their thoraco-lumbar spine (EOS system)a low-dose imaging system exploration of their thoraco-lumbar spine (EOS system)
OTHERQuestionnaires* a physical activity questionnaire (PHAS instrument) * a COPD quality of life questionnaire (St George Hospital)
OTHERA search for sarcopenia by studying the strength of the grip (dynamometer)A search for sarcopenia by studying the strength of the grip (dynamometer)

Timeline

Start date
2023-06-01
Primary completion
2025-06-01
Completion
2025-06-01
First posted
2021-02-17
Last updated
2024-01-10

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT04757714. Inclusion in this directory is not an endorsement.