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

COPD Clinical Trial

— CYPHOS  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04757714
• Other study ID #: CHRO-2020-05
• Status: Withdrawn
• Phase: N/A
• Start date: June 2023
• Est. completion date: June 2025

Study information

• Verified date: January 2024
• Source: Centre Hospitalier Régional d'Orléans
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COPD
• Kyphosis
• Lung Diseases, Obstructive
• Osteoporosis
• Pulmonary Disease, Chronic Obstructive

Intervention

Procedure:
• The high-resolution peripheral scanner (HRpQCT) of the tibia and radius
The high-resolution peripheral scanner (HRpQCT) of the tibia and radius
• 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)
• A search for sarcopenia by studying the strength of the grip (dynamometer)
A search for sarcopenia by studying the strength of the grip (dynamometer)

Locations

Country	Name	City	State
France	CHR d'ORLEANS	Orleans

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Régional d'Orléans

Country where clinical trial is conducted

France, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

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