Chronic Obstructive Pulmonary Disease (COPD) and Osteoporosis

Osteoporosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01067248
• Other study ID #: M09-1971
• Status: Completed
• Phase: N/A
• First received: February 10, 2010
• Last updated: July 28, 2015
• Start date: January 2010
• Est. completion date: December 2012

Study information

• Verified date: July 2015
• Source: Catharina Ziekenhuis Eindhoven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years and older

Eligibility

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).

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Osteoporosis
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Catharina Ziekenhuis Eindhoven	Center for Integrated Rehabilitation and Organ Failure Horn, Maastricht University Medical Center