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OpenTrials
Completed

NCT Number: NCT01067248

Chronic Obstructive Pulmonary Disease (COPD) and Osteoporosis

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Sponsors and collaborators

Lead sponsor

Catharina Ziekenhuis Eindhoven

Other

Collaborators

  • Center for Integrated Rehabilitation and Organ Failure Horn
  • Maastricht University Medical Center

Registry information

Official study title

Patho-physiology of Osteoporosis in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Feb 11, 2010
Registry last updated
Jul 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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