Clinical trial NCT01067248: Chronic Obstructive Pulmonary Disease (COPD) and Osteoporosis
Official title: Patho-physiology of Osteoporosis in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease, Chronic Obstructive
Osteoporosis
Keywords: COPD
Osteoporosis
Pathophysiology
Mechanism
Bone markers
Bone turnover
Protein turnover
Ageing
Endocrinology
Vitamin D
Lead sponsor: Catharina Ziekenhuis Eindhoven
Sponsor class: OTHER
Collaborators: name: Maastricht University Medical Center
name: Center for Integrated Rehabilitation and Organ Failure Horn
First posted: 2010-02-11
Enrollment: 120
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.

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 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).

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Maastricht University Medical Center
name: Emiel Wouters, MD, PhD, prof
role: PRINCIPAL_INVESTIGATOR
References: