COPDNCT00231127
Osteoporosis and Chronic Obstructive Pulmonary Disease (COPD)
An observational study of COPD and Osteoporosis, run by Catharina Ziekenhuis Eindhoven at 1 site in Netherlands.
Trial summary
The goals of the trial are: To determine the prevalence of osteoporosis in subgroups of COPD patients. To look for risk factors of osteoporosis in COPD patients. To create sub-groups for prospective research concerning the effects of bisphosphonates on osteoporosis variables in COPD patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD, Osteoporosis, Osteopenia
- How many people
- 250 participants
- Where
- 1 siteNetherlands
- Study dates
- Apr 2005to Jan 2009
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Chronic Obstructive Pulmonary Disease Patients visiting the pulmonary outpatient clinic of the Catharina Hospital Eindhoven.
Who may be able to join
- Age > 18 years
- Men and women
- COPD according to the ATS-guidelines, divided in severity according to the GOLD criteria
- Written consent
Who cannot join
- Age < 18 years
- No written consent
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Catharina Hospital Eindhoven
Eindhoven, North Brabant, 5602 ZA
About this study
Official title: Osteoporosis and COPD (Making of a Database)
The goals of the trial are:
- To determine the prevalence of osteoporosis in subgroups of COPD patients.
- To look for risk factors of osteoporosis in COPD patients.
- To create sub-groups for prospective research concerning the effects of bisphosphonates on osteoporosis variables in COPD patients.
Read the detailed description
Background:
Osteoporosis is defined as a systemically skeletal disorder characterized by a low bone mass and deterioration of the micro-architecture of the bone and is therefore associated with a higher risk of fractures. Large epidemiological studies to determine the incidence and prevalence of osteoporosis in COPD patients in different stages of their disease are not available. The etiology of osteoporosis in COPD patients is complex and depends on multiple factors.
Goals of the Trial:
- To determine the prevalence of osteoporosis in subgroups of COPD patients.
- To look for risk factors of osteoporosis in COPD patients.
- To create sub-groups for prospective research concerning the effects of bisphosphonates on osteoporosis variables in COPD patients.
Study Design:
Patients diagnosed with COPD (according to the American Thoracic Society [ATS] guidelines and divided in stages according to the Global Initiative on Obstructive Lung Diseases [GOLD]-classification) who visit the out-patient clinic of pulmonology of the Catharina Hospital Eindhoven will be asked to participate in the trial. A database will be created (prospectively) of the (medical) information about these patients, which will be analysed retrospective. To gather information we will use the medical records, a questionnaire, a blood sample, long function testing including a 6-minute walking test and a DEXA-scan.
- Conditions
- COPD, Osteoporosis, Osteopenia
- Keywords
- COPD, Osteoporosis, Osteopenia, Glucocorticoids, GOLD, BODE
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Osteoporosis, Bone Diseases, Metabolic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2005 (estimated)
- Study startApr 2005
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Catharina Ziekenhuis Eindhoven
- Sponsor type
- University, hospital or other
- Investigators
- Lidwien Graat, MD, Principal investigator, Catharina Hospital Eindhoven (Department of Pulmonology)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00231127
- Sponsor's protocol ID
- M05-1522
- Status last verified
- Nov 2009
- First submitted
- 3 Oct 2005
- Last updated
- 10 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Osteoporosis and COPD (Making of a Database)
- ClinicalTrials.gov ID
- NCT00231127
- Acronym / sponsor ID
- M05-1522
- Conditions
- COPD, Osteoporosis, Osteopenia
- Keywords
- COPD, Osteoporosis, Osteopenia, Glucocorticoids, GOLD, BODE
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Catharina Ziekenhuis EindhovenUniversity, hospital or other
- Study start
- Apr 2005
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 4 Oct 2005 (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 goals of the trial are:
- To determine the prevalence of osteoporosis in subgroups of COPD patients.
- To look for risk factors of osteoporosis in COPD patients.
- To create sub-groups for prospective research concerning the effects of bisphosphonates on osteoporosis variables in COPD patients.
Detailed description
Background:
Osteoporosis is defined as a systemically skeletal disorder characterized by a low bone mass and deterioration of the micro-architecture of the bone and is therefore associated with a higher risk of fractures. Large epidemiological studies to determine the incidence and prevalence of osteoporosis in COPD patients in different stages of their disease are not available. The etiology of osteoporosis in COPD patients is complex and depends on multiple factors.
Goals of the Trial:
- To determine the prevalence of osteoporosis in subgroups of COPD patients.
- To look for risk factors of osteoporosis in COPD patients.
- To create sub-groups for prospective research concerning the effects of bisphosphonates on osteoporosis variables in COPD patients.
Study Design:
Patients diagnosed with COPD (according to the American Thoracic Society [ATS] guidelines and divided in stages according to the Global Initiative on Obstructive Lung Diseases [GOLD]-classification) who visit the out-patient clinic of pulmonology of the Catharina Hospital Eindhoven will be asked to participate in the trial. A database will be created (prospectively) of the (medical) information about these patients, which will be analysed retrospective. To gather information we will use the medical records, a questionnaire, a blood sample, long function testing including a 6-minute walking test and a DEXA-scan.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chronic Obstructive Pulmonary Disease Patients visiting the pulmonary outpatient clinic of the Catharina Hospital Eindhoven.
Key inclusion criteria (4 listed)
- Age > 18 years
- Men and women
- COPD according to the ATS-guidelines, divided in severity according to the GOLD criteria
- Written consent
Key exclusion criteria (2 listed)
- Age < 18 years
- No written consent
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 10 Nov 2009.
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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.
Lidwien Graat, MD principal investigator
Catharina Hospital Eindhoven (Department of Pulmonology)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD and Osteoporosis, run by Catharina Ziekenhuis Eindhoven at 1 site in Netherlands.
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 4 inclusion and 2 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 10 Nov 2009. 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 Netherlands. 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 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 10 Nov 2009.