Case Control Study: Determinants of Osteoporosis in GOLD II COPD Patients.

Chronic Obstructive Pulmonary Disease Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00725673
• Other study ID #: M07-1752
• Secondary ID: 18223
• Status: Completed
• Phase: N/A
• First received: July 28, 2008
• Last updated: November 9, 2009
• Start date: September 2007
• Est. completion date: June 2009

Study information

• Verified date: November 2009
• Source: Catharina Ziekenhuis Eindhoven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: June 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Age >= 40 years

• GOLD II COPD

• Written permission

Exclusion Criteria:

• Age < 40 years

• No COPD or COPD GOLD I, III or IV

• no written permission

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Osteoporosis
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
Netherlands	Catharina Hospital Eindhoven	Eindhoven	Noord-Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Catharina Ziekenhuis Eindhoven

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Risk factors for osteoporosis in GOLD II COPD patients		1 year	No