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

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ClinicalTrials.gov Identifier: NCT00725673
Recruitment Status : Completed
First Posted : July 30, 2008
Last Update Posted : November 10, 2009
Sponsor:
Information provided by:
Catharina Ziekenhuis Eindhoven

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.


Condition or disease
Chronic Obstructive Pulmonary Disease Osteoporosis

Study Type : Observational
Actual Enrollment : 106 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: 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.
Study Start Date : September 2007
Primary Completion Date : April 2009
Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis
U.S. FDA Resources

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



Primary Outcome Measures :
  1. Risk factors for osteoporosis in GOLD II COPD patients [ Time Frame: 1 year ]

Biospecimen Retention:   Samples Without DNA
Whole blood


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00725673


Locations
Netherlands
Catharina Hospital Eindhoven
Eindhoven, Noord-Brabant, Netherlands, 5623 EJ
Sponsors and Collaborators
Catharina Ziekenhuis Eindhoven
Investigators
Principal Investigator: Lidwien Graat-Verboom Catharina Ziekenhuis Eindhoven

Responsible Party: L. Graat-Verboom/drs, Catharina Hospital Eindhoven
ClinicalTrials.gov Identifier: NCT00725673     History of Changes
Other Study ID Numbers: M07-1752
18223
First Posted: July 30, 2008    Key Record Dates
Last Update Posted: November 10, 2009
Last Verified: November 2009

Keywords provided by Catharina Ziekenhuis Eindhoven:
COPD
Osteoporosis
BMD
DEXA-scan

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