Ignite Creation Date:
2025-12-17 @ 8:56 PM
Ignite Modification Date:
2025-12-23 @ 10:58 PM
Study NCT ID:
NCT00725673
Status:
None
Last Update Posted:
2009-11-10 00:00:00
First Post:
2008-07-28 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Case Control Study: Determinants of Osteoporosis in GOLD II COPD Patients.
Sponsor:
None
Organization:
Study Overview
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.
Status:
None
Status Verified Date:
2009-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: