Thoracic Kyphosis and Osteoporosis: Study of Their Relationship With Respiratory Functions in Chronic Obstructive Pulmonary Disease. (CYPHOS)
Primary Purpose
COPD, Osteoporosis, Kyphosis
Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
The high-resolution peripheral scanner (HRpQCT) of the tibia and radius
a low-dose imaging system exploration of their thoraco-lumbar spine (EOS system)
Questionnaires
A search for sarcopenia by studying the strength of the grip (dynamometer)
Sponsored by
About this trial
This is an interventional diagnostic trial for COPD focused on measuring osteoporosis
Eligibility Criteria
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
Sites / Locations
- CHR d'ORLEANS
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
COPD Patients
Arm Description
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)
Outcomes
Primary Outcome Measures
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.
Forced vital capacity
Secondary Outcome Measures
Presence of densitometric osteoporosis
Presence of intermediate bone density
Percentage of maximum expiratory volume per second (FEV1), percentage predicted value
predicted value FEV1/Forced Vital Capacity
Quality of life score (St George Hospital questionnaire)
Severity index of Osteoporosis
raw BMD values
Severity index of Osteoporosis
FRAX score
Severity index of Osteoporosis
number of VFs
Chronic Obstructive Pulmonary Disease (COPD) severity index
maximum expiratory volume per second (FEV1)
Chronic Obstructive Pulmonary Disease (COPD) severity index
severity stage by the Global Initiative for Chronic Obstruction Lung Disease (GOLD)
Chronic Obstructive Pulmonary Disease (COPD) severity index
prognosis stage according to BODE index
Parameters measured by HRpQCT
volume density and microarchitecture
Densitometric osteoporosis status
The status will be determine between: Osteoporosis , intermediate bone density and normal
Full Information
NCT ID
NCT04757714
First Posted
February 12, 2021
Last Updated
January 25, 2023
Sponsor
Centre Hospitalier Régional d'Orléans
1. Study Identification
Unique Protocol Identification Number
NCT04757714
Brief Title
Thoracic Kyphosis and Osteoporosis: Study of Their Relationship With Respiratory Functions in Chronic Obstructive Pulmonary Disease.
Acronym
CYPHOS
Official Title
Thoracic Kyphosis and Osteoporosis: Study of Their Relationship With Respiratory Functions in Chronic Obstructive Pulmonary Disease.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 2023 (Anticipated)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
June 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Régional d'Orléans
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD, Osteoporosis, Kyphosis
Keywords
osteoporosis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
140 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
COPD Patients
Arm Type
Other
Arm Description
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)
Intervention Type
Procedure
Intervention Name(s)
The high-resolution peripheral scanner (HRpQCT) of the tibia and radius
Intervention Description
The high-resolution peripheral scanner (HRpQCT) of the tibia and radius
Intervention Type
Procedure
Intervention Name(s)
a low-dose imaging system exploration of their thoraco-lumbar spine (EOS system)
Intervention Description
a low-dose imaging system exploration of their thoraco-lumbar spine (EOS system)
Intervention Type
Other
Intervention Name(s)
Questionnaires
Intervention Description
a physical activity questionnaire (PHAS instrument)
a COPD quality of life questionnaire (St George Hospital)
Intervention Type
Other
Intervention Name(s)
A search for sarcopenia by studying the strength of the grip (dynamometer)
Intervention Description
A search for sarcopenia by studying the strength of the grip (dynamometer)
Primary Outcome Measure Information:
Title
The thoracic kyphosis index
Description
The kyphosis index will be used to assess thoracic kyphosis at the beginning of the study. This index is a percentage.
Time Frame
Day 0
Title
Forced vital capacity
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
Presence of densitometric osteoporosis
Time Frame
Day 0
Title
Presence of intermediate bone density
Time Frame
Day 0
Title
Percentage of maximum expiratory volume per second (FEV1), percentage predicted value
Time Frame
Day 0
Title
predicted value FEV1/Forced Vital Capacity
Time Frame
Day 0
Title
Quality of life score (St George Hospital questionnaire)
Time Frame
Day 0
Title
Severity index of Osteoporosis
Description
raw BMD values
Time Frame
Day 0
Title
Severity index of Osteoporosis
Description
FRAX score
Time Frame
Day 0
Title
Severity index of Osteoporosis
Description
number of VFs
Time Frame
Day 0
Title
Chronic Obstructive Pulmonary Disease (COPD) severity index
Description
maximum expiratory volume per second (FEV1)
Time Frame
Day 0
Title
Chronic Obstructive Pulmonary Disease (COPD) severity index
Description
severity stage by the Global Initiative for Chronic Obstruction Lung Disease (GOLD)
Time Frame
Day 0
Title
Chronic Obstructive Pulmonary Disease (COPD) severity index
Description
prognosis stage according to BODE index
Time Frame
Day 0
Title
Parameters measured by HRpQCT
Description
volume density and microarchitecture
Time Frame
Day 0
Title
Densitometric osteoporosis status
Description
The status will be determine between: Osteoporosis , intermediate bone density and normal
Time Frame
Day 0
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aurélie DESPUJOLS
Phone
+33238744071
Email
aurelie.despujols@chr-orleans.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Elodie POUGOUE TOUKO
Phone
+33238744086
Email
elodie.pougoue-touko@chr-orleans.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric LESPESSSAILLES, Ph.D.
Organizational Affiliation
CHR ORLEANS
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHR d'ORLEANS
City
Orleans
ZIP/Postal Code
45067
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric LESPESSAILLES, Ph
Email
eric.lespessailles@chr-orleans.fr
First Name & Middle Initial & Last Name & Degree
Eric LESPESSAILLES, Ph
12. IPD Sharing Statement
Citations:
PubMed Identifier
14999112
Citation
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.
Results Reference
background
PubMed Identifier
24783225
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.
Results Reference
background
PubMed Identifier
22314182
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.
Results Reference
background
PubMed Identifier
20413541
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.
Results Reference
background
PubMed Identifier
26415512
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.
Results Reference
background
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Thoracic Kyphosis and Osteoporosis: Study of Their Relationship With Respiratory Functions in Chronic Obstructive Pulmonary Disease.
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