Case Control Study: Determinants of Osteoporosis in GOLD II COPD Patients.
|ClinicalTrials.gov Identifier: NCT00725673|
Recruitment Status : Completed
First Posted : July 30, 2008
Last Update Posted : November 10, 2009
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:
- BMI/VVMI (body composition)
- emphysema vs chronic bronchitis
- physical capacity
- Use of certain medication (eg corticosteroids, SSRI's)
- Nutritional status
- Infectious parameters Outpatients from the pulmonary ward of the Catharina Hospital Eindhoven with GOLD II COPD according to the ATS and GOLD-guidelines will be included in the study (after written informed consent).
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 or disease|
|Chronic Obstructive Pulmonary Disease Osteoporosis|
|Study Type :||Observational|
|Actual Enrollment :||106 participants|
|Observational Model:||Case Control|
|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.|
|Study Start Date :||September 2007|
|Primary Completion Date :||April 2009|
|Study Completion Date :||June 2009|
GOLD II COPD patients with osteoporosis
GOLD II COPD patients with a normal bone mineral density
- Risk factors for osteoporosis in GOLD II COPD patients [ Time Frame: 1 year ]
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00725673
|Catharina Hospital Eindhoven|
|Eindhoven, Noord-Brabant, Netherlands, 5623 EJ|
|Principal Investigator:||Lidwien Graat-Verboom||Catharina Ziekenhuis Eindhoven|