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| Sponsor: | Catharina Ziekenhuis Eindhoven |
|---|---|
| Information provided by: | Catharina Ziekenhuis Eindhoven |
| ClinicalTrials.gov Identifier: | NCT00725673 |
Purpose
Patients with COPD have been found to have an increased risk of osteoporosis. The underlying mechanism is not clear yet. This case control study aims to identify risk factors for osteoporosis in GOLD II COPD patients. COPD GOLD II patients with osteoporosis (cases) will be matched by gender and age to COPD GOLD II patients without osteoporosis(controls).
Possible risk factors for osteoporosis are:
A DEXA-scan will be made, if patients are osteoporotic or have a normal BMD they will be included in the study.
A HRCT will be made, a six minutes walking distance will be performed, blood will be drawn for lab. analysis, an X-ray of the vertebral collum will be made, impedance will be measured and hight and weight will be measuered. Also patients will fill in a questionaire.
By univariate and multivariate analysis the collected data will be analysed to determine possible risk factors for th development of osteoporosis in COPD GOLD II patients.
| Condition |
|---|
|
Chronic Obstructive Pulmonary Disease Osteoporosis |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Cross-Sectional |
| Official Title: | Determination of Risk Factors for Developing Osteoporosis in COPD GOLD II Patients. A Case Control Study to Identify Possible Risk Factors for Developing Osteoporosis in COPD GOLD II Patients. |
Whole blood
| Enrollment: | 106 |
| Study Start Date: | September 2007 |
| Study Completion Date: | June 2009 |
| Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
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1
GOLD II COPD patients with osteoporosis
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2
GOLD II COPD patients with a normal bone mineral density
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Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
GOLD II COPD patients (ATS and GOLD guidelines) visiting the outpatient clinic of pulmonary medicine of the Catharina Hospital Eindhoven.
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Netherlands | |
| Catharina Hospital Eindhoven | |
| Eindhoven, Noord-Brabant, Netherlands, 5623 EJ | |
| Principal Investigator: | Lidwien Graat-Verboom | Catharina Hospital Eindhoven |
More Information
| Responsible Party: | L. Graat-Verboom/drs, Catharina Hospital Eindhoven |
| ClinicalTrials.gov Identifier: | NCT00725673 History of Changes |
| Other Study ID Numbers: | M07-1752, 18223 |
| Study First Received: | July 28, 2008 |
| Last Updated: | November 9, 2009 |
| Health Authority: | Netherlands: Medical Ethics Review Committee (METC); Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
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COPD Osteoporosis BMD DEXA-scan |
|
Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive Osteoporosis Lung Diseases, Obstructive |
Respiratory Tract Diseases Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases |
