COPDCYPHOSNCT04757714
Thoracic Kyphosis and Osteoporosis: Study of Their Relationship With Respiratory Functions in Chronic Obstructive Pulmonary Disease.
A study testing The high-resolution peripheral scanner (HRpQCT) of the tibia and radius, a low-dose imaging system exploration of their thoraco-lumbar spine (EOS system) and Questionnaires in people with COPD and Osteoporosis, run by Centre Hospitalier Régional d'Orléans at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD, Osteoporosis, Kyphosis
- What is being tested?
- The high-resolution peripheral scanner (HRpQCT) of the tibia and radius, a low-dose imaging system exploration of their thoraco-lumbar spine (EOS system) and Questionnaires
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2023to Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the 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
- COPD, Osteoporosis, Kyphosis
- Being tested
- 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)
- Keywords
- osteoporosis
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Osteoporosis, Kyphosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The high-resolution peripheral scanner (HRpQCT) of the tibia and radiusProcedure or surgery
The high-resolution peripheral scanner (HRpQCT) of the tibia and radius
a low-dose imaging system exploration of their thoraco-lumbar spine (EOS system)Procedure or surgery
a low-dose imaging system exploration of their thoraco-lumbar spine (EOS system)
QuestionnairesOther
- 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)Other
A search for sarcopenia by studying the strength of the grip (dynamometer)
| Study group | Role | What they receive |
|---|---|---|
| COPD Patients | Other | 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) Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 0
Forced vital capacity
Measured: Day 0
Secondary outcomes (13)
Presence of densitometric osteoporosis
Measured: Day 0
Presence of intermediate bone density
Measured: Day 0
Percentage of maximum expiratory volume per second (FEV1), percentage predicted value
Measured: Day 0
predicted value FEV1/Forced Vital Capacity
Measured: Day 0
Quality of life score (St George Hospital questionnaire)
Measured: Day 0
Severity index of Osteoporosis
raw BMD values
Measured: Day 0
Severity index of Osteoporosis
FRAX score
Measured: Day 0
Severity index of Osteoporosis
number of VFs
Measured: Day 0
Chronic Obstructive Pulmonary Disease (COPD) severity index
maximum expiratory volume per second (FEV1)
Measured: Day 0
Chronic Obstructive Pulmonary Disease (COPD) severity index
severity stage by the Global Initiative for Chronic Obstruction Lung Disease (GOLD)
Measured: Day 0
Chronic Obstructive Pulmonary Disease (COPD) severity index
prognosis stage according to BODE index
Measured: Day 0
Parameters measured by HRpQCT
volume density and microarchitecture
Measured: Day 0
Densitometric osteoporosis status
The status will be determine between: Osteoporosis , intermediate bone density and normal
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2021
- Study startJun 2023 (estimated)
- Primary completionJun 2025 (estimated)
- Study completionJun 2025 (estimated)
Why it stopped: The site is no more able to conduct the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional d'Orléans
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric LESPESSSAILLES, Ph.D., Principal investigator, CHR ORLEANS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04757714
- Sponsor's protocol ID
- CHRO-2020-05
- Acronym
- CYPHOS
- Status last verified
- Jan 2024
- First submitted
- 12 Feb 2021
- Last updated
- 10 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 14999112Cielen 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.
PubMed 24783225Decramer 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.
PubMed 22314182Eagan 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.
PubMed 20413541Ekblom 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.
PubMed 26415512
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thoracic Kyphosis and Osteoporosis: Study of Their Relationship With Respiratory Functions in Chronic Obstructive Pulmonary Disease.
- ClinicalTrials.gov ID
- NCT04757714
- Acronym / sponsor ID
- CYPHOS / CHRO-2020-05
- Conditions
- COPD, Osteoporosis, Kyphosis
- Keywords
- osteoporosis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The site is no more able to conduct the study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional d'OrléansUniversity, hospital or other
- Study start
- Jun 2023 (estimated)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 17 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COPD Patients | Other | 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)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) |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The high-resolution peripheral scanner (HRpQCT) of the tibia and radiusThe high-resolution peripheral scanner (HRpQCT) of the tibia and radius | Procedure or surgery | COPD Patients |
| 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) | Procedure or surgery | COPD Patients |
| Questionnaires* a physical activity questionnaire (PHAS instrument) * a COPD quality of life questionnaire (St George Hospital) | Other | COPD Patients |
| A search for sarcopenia by studying the strength of the grip (dynamometer)A search for sarcopenia by studying the strength of the grip (dynamometer) | Other | COPD Patients |
Primary outcome
The thoracic kyphosis index
Time frame: 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
Time frame: Day 0
13 secondary outcomes
Presence of densitometric osteoporosis
Time frame: Day 0
Presence of intermediate bone density
Time frame: Day 0
Percentage of maximum expiratory volume per second (FEV1), percentage predicted value
Time frame: Day 0
predicted value FEV1/Forced Vital Capacity
Time frame: Day 0
Quality of life score (St George Hospital questionnaire)
Time frame: Day 0
Severity index of Osteoporosis
Time frame: Day 0
Severity index of Osteoporosis
Time frame: Day 0
Severity index of Osteoporosis
Time frame: Day 0
Chronic Obstructive Pulmonary Disease (COPD) severity index
Time frame: Day 0
Chronic Obstructive Pulmonary Disease (COPD) severity index
Time frame: Day 0
Chronic Obstructive Pulmonary Disease (COPD) severity index
Time frame: Day 0
Parameters measured by HRpQCT
Time frame: Day 0
Densitometric osteoporosis status
Time frame: Day 0
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2024.
- Background: PubMed 14999112Celli 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.
- Background: PubMed 24783225Cielen 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.
- Background: PubMed 22314182Decramer 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.
- Background: PubMed 20413541Eagan 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.
- Background: PubMed 26415512Ekblom 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric LESPESSSAILLES, Ph.D. principal investigator
CHR ORLEANS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The high-resolution peripheral scanner (HRpQCT) of the tibia and radius, a low-dose imaging system exploration of their thoraco-lumbar spine (EOS system) and Questionnaires in people with COPD and Osteoporosis, run by Centre Hospitalier Régional d'Orléans at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 10 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The thoracic kyphosis index (time frame: Day 0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04757714, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2024.