Trial record 16 of 973 for:    "Osteoporosis"

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

This study has been completed.
Sponsor:
Information provided by:
Catharina Ziekenhuis Eindhoven
ClinicalTrials.gov Identifier:
NCT00725673
First received: July 28, 2008
Last updated: November 9, 2009
Last verified: November 2009
  Purpose

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
Chronic Obstructive Pulmonary Disease
Osteoporosis

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Catharina Ziekenhuis Eindhoven:

Primary Outcome Measures:
  • Risk factors for osteoporosis in GOLD II COPD patients [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Whole blood


Enrollment: 106
Study Start Date: September 2007
Study Completion Date: June 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
GOLD II COPD patients with osteoporosis
2
GOLD II COPD patients with a normal bone mineral density

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 Hospital Eindhoven
  More Information

No publications provided

Responsible Party: L. Graat-Verboom/drs, Catharina Hospital Eindhoven
ClinicalTrials.gov Identifier: NCT00725673     History of Changes
Other Study ID Numbers: M07-1752, 18223
Study First Received: July 28, 2008
Last Updated: November 9, 2009
Health Authority: Netherlands: Medical Ethics Review Committee (METC)
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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

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

ClinicalTrials.gov processed this record on October 30, 2014