Osteoporosis and Chronic Obstructive Pulmonary Disease (COPD)

NCT ID: NCT00231127

Last Updated: 2009-11-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 250 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2005-04-30
• Study Completion Date: 2009-01-31

Brief Summary

The goals of the trial are:

• To determine the prevalence of osteoporosis in subgroups of COPD patients.
• To look for risk factors of osteoporosis in COPD patients.
• To create sub-groups for prospective research concerning the effects of bisphosphonates on osteoporosis variables in COPD patients.

Detailed Description

Background:

Osteoporosis is defined as a systemically skeletal disorder characterized by a low bone mass and deterioration of the micro-architecture of the bone and is therefore associated with a higher risk of fractures. Large epidemiological studies to determine the incidence and prevalence of osteoporosis in COPD patients in different stages of their disease are not available. The etiology of osteoporosis in COPD patients is complex and depends on multiple factors.

Goals of the Trial:

• To determine the prevalence of osteoporosis in subgroups of COPD patients.
• To look for risk factors of osteoporosis in COPD patients.
• To create sub-groups for prospective research concerning the effects of bisphosphonates on osteoporosis variables in COPD patients.

Study Design:

Patients diagnosed with COPD (according to the American Thoracic Society [ATS] guidelines and divided in stages according to the Global Initiative on Obstructive Lung Diseases [GOLD]-classification) who visit the out-patient clinic of pulmonology of the Catharina Hospital Eindhoven will be asked to participate in the trial. A database will be created (prospectively) of the (medical) information about these patients, which will be analysed retrospective. To gather information we will use the medical records, a questionnaire, a blood sample, long function testing including a 6-minute walking test and a DEXA-scan.

Conditions

COPD; Osteoporosis; Osteopenia

Study Design

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

Eligibility Criteria

Inclusion Criteria

• Age > 18 years
• Men and women
• COPD according to the ATS-guidelines, divided in severity according to the GOLD criteria
• Written consent

Exclusion Criteria

• Age < 18 years
• No written consent

• Minimum Eligible Age: 18 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, MD

Role: PRINCIPAL_INVESTIGATOR

Catharina Hospital Eindhoven (Department of Pulmonology)

Locations

Catharina Hospital Eindhoven

Eindhoven, North Brabant, Netherlands

Countries

Netherlands

Other Identifiers

M05-1522

Identifier Type: -

Identifier Source: org_study_id