Chronic Obstructive Pulmonary Disease (COPD) and Osteoporosis

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

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.

Study Overview

• Status: Completed
• Conditions: 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
• Enrollment (Actual): 120

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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.

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: February 10, 2010
• First Submitted That Met QC Criteria: February 10, 2010
• First Posted (Estimate): February 11, 2010

Study Record Updates

• Last Update Posted (Estimate): July 29, 2015
• Last Update Submitted That Met QC Criteria: July 28, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: Vitamin D; COPD; Ageing; Endocrinology; Pathophysiology; Osteoporosis; Bone markers; Bone turnover; Mechanism; Protein turnover
• Additional Relevant MeSH Terms: Metabolic Diseases; Respiratory Tract Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Osteoporosis
• Other Study ID Numbers: M09-1971