Osteoporosis and Chronic Obstructive Pulmonary Disease (COPD)

November 9, 2009 updated by: Catharina Ziekenhuis Eindhoven

Osteoporosis and COPD (Making of a Database)

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Noord-Brabant
      • Eindhoven, Noord-Brabant, Netherlands, 5602 ZA
        • Catharina Hospital Eindhoven

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Chronic Obstructive Pulmonary Disease Patients visiting the pulmonary outpatient clinic of the Catharina Hospital Eindhoven.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Catharina Ziekenhuis Eindhoven

Investigators

  • Principal Investigator: Lidwien Graat, MD, Catharina Hospital Eindhoven (Department of Pulmonology)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

October 3, 2005

First Submitted That Met QC Criteria

October 3, 2005

First Posted (Estimate)

October 4, 2005

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M05-1522

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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