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Chronic Obstructive Pulmonary Disease (COPD) and Osteoporosis

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Maastricht University Medical Center
Center for Integrated Rehabilitation and Organ Failure Horn
Information provided by:
Catharina Ziekenhuis Eindhoven
ClinicalTrials.gov Identifier:
NCT01067248
First received: February 10, 2010
Last updated: February 18, 2010
Last verified: February 2010
  Purpose

The main objective is to study important factors in the patho-physiology of osteoporosis in patients with COPD. Therefore, the investigators will study biological markers in plasma and urine and correlate them to markers of bone turnover and clinical data.


Condition
Pulmonary Disease, Chronic Obstructive
Osteoporosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Patho-physiology of Osteoporosis in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Resource links provided by NLM:


Further study details as provided by Catharina Ziekenhuis Eindhoven:

Biospecimen Retention:   Samples With DNA

Markers of ageing, such as telomere length and sirtuin 1.


Estimated Enrollment: 120
Study Start Date: January 2010
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
COPD, osteoporosis
The subjects are divided into 6 groups of 20 subjects each, I: COPD patients with osteoporosis based on T-score and without vertebral fractures, II: COPD patients with osteoporosis based on T-score and vertebral fractures, III: COPD patients with vertebral fractures and without osteoporosis based on T-score, IV: COPD patients without osteoporosis based on T-score and without vertebral fractures, V: healthy controls with osteoporosis based on T-score and without vertebral fractures, VI: healthy controls without osteoporosis based on T-score and without vertebral fractures.

Detailed Description:

Rationale:

Chronic obstructive pulmonary disease (COPD) is defined as a preventable and treatable disease with significant extrapulmonary effects. Osteoporosis is recognized as one of these extrapulmonary consequences. It results in increased risk of fracture and thereby an increased morbidity and mortality. Nowadays it is believed that the patho-physiology of osteoporosis is multi-factorial. However, which factors are most important in patients with COPD is still not clear.

Objective:

The main objective is to study important factors in the patho-physiology of osteoporosis in patients with COPD. Therefore, we will study biological markers in plasma and urine and correlate them to markers of bone turnover and clinical data.

Study design:

The present study will be an observational, cross-sectional study.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

In total 120 patients will be included. All subjects will be included from the outdoor clinic of the department of Pulmonology of the Catharina Hospital Eindhoven or Diagnostic Centre Eindhoven (DCE). The subjects are divided into 6 groups of 20 subjects each, I: COPD patients with osteoporosis based on T-score and without vertebral fractures, II: COPD patients with osteoporosis based on T-score and vertebral fractures, III: COPD patients with vertebral fractures and without osteoporosis based on T-score, IV: COPD patients without osteoporosis based on T-score and without vertebral fractures, V: healthy controls with osteoporosis based on T-score and without vertebral fractures, VI: healthy controls without osteoporosis based on T-score and without vertebral fractures.

Criteria

Inclusion Criteria for the COPD patients:

  • Aged 50 years or older;
  • Women have to be postmenopausal (amenorrhea for 12 months or more)
  • COPD Global initiative of Obstructive Lung Disease (GOLD) I, II, III and IV according to the American Thoracic Society (ATS) guidelines;
  • ≥ 12 pack years;
  • No respiratory tract infection or exacerbation of the disease for at least 4 weeks before the study;
  • No use of oral corticosteroids for at least 4 weeks before the study;
  • No use of anti-osteoporotic medication (calcium, vitamin D, biphosphonates) before inclusion;
  • Capable to provide informed consent.

Exclusion Criteria for the COPD patients:

  • Malignancy in the last 5 years;
  • Lung fibrosis;
  • Inflammatory bowel disease;
  • Rheumatoid arthritis;
  • Alcohol abuse;
  • Bronchiectasia;
  • Auto immune diseases;
  • Hypothyroidism or hyperthyroidism based on blood sampling for thyroid hormone (TSH, fT4).
  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: NCT01067248

Locations
Netherlands
Catharina Hospital Eindhoven
Eindhoven, Netherlands
Sponsors and Collaborators
Catharina Ziekenhuis Eindhoven
Maastricht University Medical Center
Center for Integrated Rehabilitation and Organ Failure Horn
Investigators
Principal Investigator: E Wouters, MD, PhD, prof Maastricht University Medical Center
  More Information

No publications provided

Responsible Party: Prof Wouters (MD, PhD), University Hospital Maastricht
ClinicalTrials.gov Identifier: NCT01067248     History of Changes
Other Study ID Numbers: M09-1971
Study First Received: February 10, 2010
Last Updated: February 18, 2010
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Catharina Ziekenhuis Eindhoven:
COPD
Osteoporosis
Pathophysiology
Mechanism
Bone markers
Bone turnover
Protein turnover
Ageing
Endocrinology
Vitamin D

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

ClinicalTrials.gov processed this record on November 24, 2014