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

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.

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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease; Osteoporosis

• Study Type: Observational
• Enrollment (Actual): 106

Contacts and Locations

Study Locations

• Netherlands
  • Noord-Brabant
    • Eindhoven, Noord-Brabant, Netherlands, 5623 EJ
      • Catharina Hospital Eindhoven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 36 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

GOLD II COPD patients (ATS and GOLD guidelines) visiting the outpatient clinic of pulmonary medicine of the Catharina Hospital Eindhoven.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
1; GOLD II COPD patients with osteoporosis
2; GOLD II COPD patients with a normal bone mineral density

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Risk factors for osteoporosis in GOLD II COPD patients	1 year

Collaborators and Investigators

• Sponsor: Catharina Ziekenhuis Eindhoven
• Investigators: Principal Investigator: Lidwien Graat-Verboom, Catharina Ziekenhuis Eindhoven

Study record dates

Study Major Dates

• Study Start: September 1, 2007
• Primary Completion (Actual): April 1, 2009
• Study Completion (Actual): June 1, 2009

Study Registration Dates

• First Submitted: July 28, 2008
• First Submitted That Met QC Criteria: July 29, 2008
• First Posted (Estimate): July 30, 2008

Study Record Updates

• Last Update Posted (Estimate): November 10, 2009
• Last Update Submitted That Met QC Criteria: November 9, 2009
• Last Verified: November 1, 2009

More Information

Terms related to this study

• Keywords: COPD; Osteoporosis; BMD; DEXA-scan
• Additional Relevant MeSH Terms: Metabolic Diseases; Respiratory Tract Diseases; Lung Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Osteoporosis
• Other Study ID Numbers: M07-1752; 18223