Pulmonary Disease, Chronic ObstructiveNCT01067248
Chronic Obstructive Pulmonary Disease (COPD) and Osteoporosis
An observational study of Pulmonary Disease, Chronic Obstructive and Osteoporosis, run by Catharina Ziekenhuis Eindhoven.
Trial summary
The main objective is to study important factors in the patho-physiology of osteoporosis in patients with COPD. Therefore, the investigators will study biological markers in plasma and urine and correlate them to markers of bone turnover and clinical data. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive, Osteoporosis
- Type of treatment
- Injection or infusion
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Dec 2012
- Phase
- Observational
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: In total 120 patients will be included. All subjects will be included from the outdoor clinic of the department of Pulmonology of the Catharina Hospital Eindhoven or Diagnostic Centre Eindhoven (DCE). The subjects are divided into 6 groups of 20 subjects each, I: COPD patients with osteoporosis based on T-score and without vertebral fractures, II: COPD patients with osteoporosis based on T-score and vertebral fractures, III: COPD patients with vertebral fractures and without osteoporosis based on T-score, IV: COPD patients without osteoporosis based on T-score and without vertebral fractures, V: healthy controls with osteoporosis based on T-score and without vertebral fractures, VI: healthy controls without osteoporosis based on T-score and without vertebral fractures.
Who may be able to join
- Aged 50 years or older;
- Women have to be postmenopausal (amenorrhea for 12 months or more)
- COPD Global initiative of Obstructive Lung Disease (GOLD) I, II, III and IV according to the American Thoracic Society (ATS) guidelines;
- ≥ 12 pack years;
- No respiratory tract infection or exacerbation of the disease for at least 4 weeks before the study;
- No use of oral corticosteroids for at least 4 weeks before the study;
- No use of anti-osteoporotic medication (calcium, vitamin D, biphosphonates) before inclusion;
- Capable to provide informed consent.
Who cannot join
- Malignancy in the last 5 years;
- Lung fibrosis;
- Inflammatory bowel disease;
- Rheumatoid arthritis;
- Alcohol abuse;
- Bronchiectasia;
- Auto immune diseases;
- Hypothyroidism or hyperthyroidism based on blood sampling for thyroid hormone (TSH, fT4).
About this study
Official title: Patho-physiology of Osteoporosis in Patients With Chronic Obstructive Pulmonary Disease (COPD)
The main objective is to study important factors in the patho-physiology of osteoporosis in patients with COPD. Therefore, the investigators will study biological markers in plasma and urine and correlate them to markers of bone turnover and clinical data.
Read the detailed description
Rationale:
Chronic obstructive pulmonary disease (COPD) is defined as a preventable and treatable disease with significant extrapulmonary effects. Osteoporosis is recognized as one of these extrapulmonary consequences. It results in increased risk of fracture and thereby an increased morbidity and mortality. Nowadays it is believed that the patho-physiology of osteoporosis is multi-factorial. However, which factors are most important in patients with COPD is still not clear.
Objective:
The main objective is to study important factors in the patho-physiology of osteoporosis in patients with COPD. Therefore, we will study biological markers in plasma and urine and correlate them to markers of bone turnover and clinical data.
Study design:
The present study will be an observational, cross-sectional study.
- Keywords
- COPD, Osteoporosis, Pathophysiology, Mechanism, Bone markers, Bone turnover, Protein turnover, Ageing, Endocrinology, Vitamin D
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| COPD, osteoporosis | The subjects are divided into 6 groups of 20 subjects each, I: COPD patients with osteoporosis based on T-score and without vertebral fractures, II: COPD patients with osteoporosis based on T-score and vertebral fractures, III: COPD patients with vertebral fractures and without osteoporosis based on T-score, IV: COPD patients without osteoporosis based on T-score and without vertebral fractures, V: healthy controls with osteoporosis based on T-score and without vertebral fractures, VI: healthy controls without osteoporosis based on T-score and without vertebral fractures. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2010 (estimated)
- Study startJan 2010
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catharina Ziekenhuis Eindhoven
- Sponsor type
- University, hospital or other
- Collaborators
- Maastricht University Medical Center, Center for Integrated Rehabilitation and Organ Failure Horn
- Responsible party
- Principal investigator, Lisette Romme, Catharina Ziekenhuis Eindhoven
- Investigators
- Emiel Wouters, MD, PhD, prof, Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01067248
- Sponsor's protocol ID
- M09-1971
- Status last verified
- Jul 2015
- First submitted
- 10 Feb 2010
- Last updated
- 29 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patho-physiology of Osteoporosis in Patients With Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT01067248
- Acronym / sponsor ID
- M09-1971
- Keywords
- COPD, Osteoporosis, Pathophysiology, Mechanism, Bone markers, Bone turnover, Protein turnover, Ageing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Catharina Ziekenhuis EindhovenUniversity, hospital or other
- Collaborators
- Maastricht University Medical Center, Center for Integrated Rehabilitation and Organ Failure Horn
- Study start
- Jan 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 11 Feb 2010 (estimated)
- 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.
The main objective is to study important factors in the patho-physiology of osteoporosis in patients with COPD. Therefore, the investigators will study biological markers in plasma and urine and correlate them to markers of bone turnover and clinical data.
Detailed description
Rationale:
Chronic obstructive pulmonary disease (COPD) is defined as a preventable and treatable disease with significant extrapulmonary effects. Osteoporosis is recognized as one of these extrapulmonary consequences. It results in increased risk of fracture and thereby an increased morbidity and mortality. Nowadays it is believed that the patho-physiology of osteoporosis is multi-factorial. However, which factors are most important in patients with COPD is still not clear.
Objective:
The main objective is to study important factors in the patho-physiology of osteoporosis in patients with COPD. Therefore, we will study biological markers in plasma and urine and correlate them to markers of bone turnover and clinical data.
Study design:
The present study will be an observational, cross-sectional study.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COPD, osteoporosis | – | –The subjects are divided into 6 groups of 20 subjects each, I: COPD patients with osteoporosis based on T-score and without vertebral fractures, II: COPD patients with osteoporosis based on T-score and vertebral fractures, III: COPD patients with vertebral fractures and without osteoporosis based on T-score, IV: COPD patients without osteoporosis based on T-score and without vertebral fractures, V: healthy controls with osteoporosis based on T-score and without vertebral fractures, VI: healthy controls without osteoporosis based on T-score and without vertebral fractures. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- In total 120 patients will be included. All subjects will be included from the outdoor clinic of the department of Pulmonology of the Catharina Hospital Eindhoven or Diagnostic Centre Eindhoven (DCE). The subjects are divided into 6 groups of 20 subjects each, I: COPD patients with osteoporosis based on T-score and without vertebral fractures, II: COPD patients with osteoporosis based on T-score and vertebral fractures, III: COPD patients with vertebral fractures and without osteoporosis based on T-score, IV: COPD patients without osteoporosis based on T-score and without vertebral fractures, V: healthy controls with osteoporosis based on T-score and without vertebral fractures, VI: healthy controls without osteoporosis based on T-score and without vertebral fractures.
Key inclusion criteria (8 listed)
- Aged 50 years or older;
- Women have to be postmenopausal (amenorrhea for 12 months or more)
- COPD Global initiative of Obstructive Lung Disease (GOLD) I, II, III and IV according to the American Thoracic Society (ATS) guidelines;
- ≥ 12 pack years;
- No respiratory tract infection or exacerbation of the disease for at least 4 weeks before the study;
Key exclusion criteria (8 listed)
- Malignancy in the last 5 years;
- Lung fibrosis;
- Inflammatory bowel disease;
- Rheumatoid arthritis;
- Alcohol abuse;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2015.
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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.
Emiel Wouters, MD, PhD, prof principal investigator
Maastricht University Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Disease, Chronic Obstructive and Osteoporosis, run by Catharina Ziekenhuis Eindhoven.
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 8 inclusion and 8 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: finished, as of the sponsor's last update on 29 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
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 29 Jul 2015.