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

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).

Study Overview

• Status: Withdrawn
• Conditions: Osteoporosis; COPD; Kyphosis
• Intervention / Treatment: 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)

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elodie POUGOUE TOUKO; Phone Number: +33238744086; Email: elodie.pougoue-touko@chr-orleans.fr

Study Locations

• France
  • Orleans, France, 45067
    • CHR d'Orléans
    • Contact: Eric LESPESSAILLES, Ph; Email: eric.lespessailles@chr-orleans.fr
    • Principal Investigator: Eric LESPESSAILLES, Ph

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: COPD Patients; 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)

Procedure: The high-resolution peripheral scanner (HRpQCT) of the tibia and radius; 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); a low-dose imaging system exploration of their thoraco-lumbar spine (EOS system); Other: Questionnaires; a physical activity questionnaire (PHAS instrument); a COPD quality of life questionnaire (St George Hospital); Other: A search for sarcopenia by studying the strength of the grip (dynamometer); A search for sarcopenia by studying the strength of the grip (dynamometer)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of densitometric osteoporosis		Day 0
Presence of intermediate bone density		Day 0
Percentage of maximum expiratory volume per second (FEV1), percentage predicted value		Day 0
predicted value FEV1/Forced Vital Capacity		Day 0
Quality of life score (St George Hospital questionnaire)		Day 0
Severity index of Osteoporosis	raw BMD values	Day 0
Severity index of Osteoporosis	FRAX score	Day 0
Severity index of Osteoporosis	number of VFs	Day 0
Chronic Obstructive Pulmonary Disease (COPD) severity index	maximum expiratory volume per second (FEV1)	Day 0
Chronic Obstructive Pulmonary Disease (COPD) severity index	severity stage by the Global Initiative for Chronic Obstruction Lung Disease (GOLD)	Day 0
Chronic Obstructive Pulmonary Disease (COPD) severity index	prognosis stage according to BODE index	Day 0
Parameters measured by HRpQCT	volume density and microarchitecture	Day 0
Densitometric osteoporosis status	The status will be determine between: Osteoporosis , intermediate bone density and normal	Day 0

Collaborators and Investigators

• Sponsor: Centre Hospitalier Régional d'Orléans
• Investigators: Principal Investigator: Eric LESPESSSAILLES, Ph.D., CHR Orléans

Publications and helpful links

General Publications

• Celli BR, Cote CG, Marin JM, Casanova C, Montes de Oca M, Mendez RA, Pinto Plata V, Cabral HJ. The body-mass index, airflow obstruction, dyspnea, and exercise capacity index in chronic obstructive pulmonary disease. N Engl J Med. 2004 Mar 4;350(10):1005-12. doi: 10.1056/NEJMoa021322.
• Cielen N, Maes K, Gayan-Ramirez G. Musculoskeletal disorders in chronic obstructive pulmonary disease. Biomed Res Int. 2014;2014:965764. doi: 10.1155/2014/965764. Epub 2014 Mar 25.
• Decramer M, Janssens W, Miravitlles M. Chronic obstructive pulmonary disease. Lancet. 2012 Apr 7;379(9823):1341-51. doi: 10.1016/S0140-6736(11)60968-9. Epub 2012 Feb 6.
• Eagan TM, Aukrust P, Ueland T, Hardie JA, Johannessen A, Mollnes TE, Damas JK, Bakke PS, Wagner PD. Body composition and plasma levels of inflammatory biomarkers in COPD. Eur Respir J. 2010 Nov;36(5):1027-33. doi: 10.1183/09031936.00194209. Epub 2010 Apr 22.
• Ekblom O, Ekblom-Bak E, Bolam KA, Ekblom B, Schmidt C, Soderberg S, Bergstrom G, Borjesson M. Concurrent and predictive validity of physical activity measurement items commonly used in clinical settings--data from SCAPIS pilot study. BMC Public Health. 2015 Sep 28;15:978. doi: 10.1186/s12889-015-2316-y.

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2023
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: February 12, 2021
• First Submitted That Met QC Criteria: February 12, 2021
• First Posted (Actual): February 17, 2021

Study Record Updates

• Last Update Posted (Actual): January 10, 2024
• Last Update Submitted That Met QC Criteria: January 8, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: osteoporosis
• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Bone Diseases, Metabolic; Chronic Disease; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Osteoporosis; Kyphosis
• Other Study ID Numbers: CHRO-2020-05

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No