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

NCT ID: NCT00725673

Last Updated: 2009-11-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 106 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2009-06-30

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.

Conditions

Chronic Obstructive Pulmonary Disease; Osteoporosis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

1

GOLD II COPD patients with osteoporosis

No interventions assigned to this group

2

GOLD II COPD patients with a normal bone mineral density

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Catharina Ziekenhuis Eindhoven

OTHER

Sponsor Role: lead

Responsible Party

Catharina Hospital Eindhoven

Principal Investigators

Lidwien Graat-Verboom

Role: PRINCIPAL_INVESTIGATOR

Catharina Ziekenhuis Eindhoven

Locations

Catharina Hospital Eindhoven

Eindhoven, North Brabant, Netherlands

Countries

Netherlands

Other Identifiers

18223

Identifier Type: -

Identifier Source: secondary_id

M07-1752

Identifier Type: -

Identifier Source: org_study_id