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Chronic Obstructive Pulmonary Disease (COPD) and Osteoporosis

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ClinicalTrials.gov Identifier: NCT01067248
Recruitment Status : Completed
First Posted : February 11, 2010
Last Update Posted : July 29, 2015
Sponsor:
Collaborators:
Maastricht University Medical Center
Center for Integrated Rehabilitation and Organ Failure Horn
Information provided by (Responsible Party):
Lisette Romme, Catharina Ziekenhuis Eindhoven

Brief Summary:
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 or disease
Pulmonary Disease, Chronic Obstructive Osteoporosis

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.


Study Type : Observational
Actual Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Patho-physiology of Osteoporosis in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Study Start Date : January 2010
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
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.



Biospecimen Retention:   Samples With DNA
Markers of ageing, such as telomere length and sirtuin 1.


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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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).

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): NCT01067248


Sponsors and Collaborators
Catharina Ziekenhuis Eindhoven
Maastricht University Medical Center
Center for Integrated Rehabilitation and Organ Failure Horn
Investigators
Principal Investigator: Emiel Wouters, MD, PhD, prof Maastricht University Medical Center

Responsible Party: Lisette Romme, MD, PhD, Catharina Ziekenhuis Eindhoven
ClinicalTrials.gov Identifier: NCT01067248     History of Changes
Other Study ID Numbers: M09-1971
First Posted: February 11, 2010    Key Record Dates
Last Update Posted: July 29, 2015
Last Verified: July 2015

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

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