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

Not Applicable

Withdrawn

• Conditions: Kyphosis; Osteoporosis; COPD
• Interventions: Procedure: The high-resolution peripheral scanner (HRpQCT) of the tibia and radius; Procedure: a low-dose imaging system exploration of their thoraco-lumbar spine (EOS system); Other: Questionnaires; Other: A search for sarcopenia by studying the strength of the grip (dynamometer)

• Registration Number: NCT04757714
• Lead Sponsor: Centre Hospitalier Régional d'Orléans

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.

Study Timeline

• Study First Submitted: 2021-02-12
• Study First Submitted QC: 2021-02-12
• Study First Posted: 2021-02-17
• Study Start: 2023-06
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-08
• Last Update Posted: 2024-01-10
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Man or woman age > 40
• FEV1/CVF ratio < 0.7 as defined by the Global Initiative for Chronic Obstruction Lung Disease (GOLD).
• Moderate to severe COPD as defined by GOLD (grade C and D)

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Exclusion Criteria

• Presence of metal or plastic parts in the field of examination
• Pregnancy
• Patients who are not affiliated with or do not benefit from a social security system
• Person under guardianship or curatorship

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
COPD Patients	a low-dose imaging system exploration of their thoraco-lumbar spine (EOS system)	Patients agreeing to participate in the study and meeting the inclusion and non-inclusion criteria will have: * The high-resolution peripheral scanner (HRpQCT) of the tibia and radius * a low-dose imaging system exploration of their thoraco-lumbar spine (EOS system) * to complete: * a physical activity questionnaire (PHAS instrument) * a COPD quality of life questionnaire (St George Hospital) * A search for sarcopenia by studying the strength of the grip (dynamometer)
COPD Patients	A search for sarcopenia by studying the strength of the grip (dynamometer)	Patients agreeing to participate in the study and meeting the inclusion and non-inclusion criteria will have: * The high-resolution peripheral scanner (HRpQCT) of the tibia and radius * a low-dose imaging system exploration of their thoraco-lumbar spine (EOS system) * to complete: * a physical activity questionnaire (PHAS instrument) * a COPD quality of life questionnaire (St George Hospital) * A search for sarcopenia by studying the strength of the grip (dynamometer)
COPD Patients	Questionnaires	Patients agreeing to participate in the study and meeting the inclusion and non-inclusion criteria will have: * The high-resolution peripheral scanner (HRpQCT) of the tibia and radius * a low-dose imaging system exploration of their thoraco-lumbar spine (EOS system) * to complete: * a physical activity questionnaire (PHAS instrument) * a COPD quality of life questionnaire (St George Hospital) * A search for sarcopenia by studying the strength of the grip (dynamometer)
COPD Patients	The high-resolution peripheral scanner (HRpQCT) of the tibia and radius	Patients agreeing to participate in the study and meeting the inclusion and non-inclusion criteria will have: * The high-resolution peripheral scanner (HRpQCT) of the tibia and radius * a low-dose imaging system exploration of their thoraco-lumbar spine (EOS system) * to complete: * a physical activity questionnaire (PHAS instrument) * a COPD quality of life questionnaire (St George Hospital) * A search for sarcopenia by studying the strength of the grip (dynamometer)

Primary Outcome Measures

Name	Time	Method
The thoracic kyphosis index	Day 0	The kyphosis index will be used to assess thoracic kyphosis at the beginning of the study. This index is a percentage.
Forced vital capacity	Day 0

Secondary Outcome Measures

Name	Time	Method
predicted value FEV1/Forced Vital Capacity	Day 0
Presence of densitometric osteoporosis	Day 0
Presence of intermediate bone density	Day 0
Quality of life score (St George Hospital questionnaire)	Day 0
Chronic Obstructive Pulmonary Disease (COPD) severity index	Day 0	prognosis stage according to BODE index
Percentage of maximum expiratory volume per second (FEV1), percentage predicted value	Day 0
Severity index of Osteoporosis	Day 0	number of VFs
Parameters measured by HRpQCT	Day 0	volume density and microarchitecture
Densitometric osteoporosis status	Day 0	The status will be determine between: Osteoporosis , intermediate bone density and normal

Trial Locations

Locations (1)

CHR d'ORLEANS; 🇫🇷 Orleans, France