Osteoporosis and Chronic Obstructive Pulmonary Disease (COPD)

This study has been completed.
Sponsor:
Information provided by:
Catharina Ziekenhuis Eindhoven
ClinicalTrials.gov Identifier:
NCT00231127
First received: October 3, 2005
Last updated: November 9, 2009
Last verified: November 2009
  Purpose

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.

Condition
COPD
Osteoporosis
Osteopenia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Osteoporosis and COPD (Making of a Database)

Resource links provided by NLM:


Further study details as provided by Catharina Ziekenhuis Eindhoven:

Estimated Enrollment: 250
Study Start Date: April 2005
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00231127

Locations
Netherlands
Catharina Hospital Eindhoven
Eindhoven, Noord-Brabant, Netherlands, 5602 ZA
Sponsors and Collaborators
Catharina Ziekenhuis Eindhoven
Investigators
Principal Investigator: Lidwien Graat, MD Catharina Hospital Eindhoven (Department of Pulmonology)
  More Information

No publications provided

Responsible Party: Lidwien Graat-Verboom/MD (principal investigator), Catharina Hospital Eindhoven
ClinicalTrials.gov Identifier: NCT00231127     History of Changes
Other Study ID Numbers: M05-1522
Study First Received: October 3, 2005
Last Updated: November 9, 2009
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Catharina Ziekenhuis Eindhoven:
COPD
Osteoporosis
Osteopenia
Glucocorticoids
GOLD
BODE

Additional relevant MeSH terms:
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Bone Diseases, Metabolic
Osteoporosis
Lung Diseases, Obstructive
Respiratory Tract Diseases
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on April 23, 2014