Chronic Obstructive Pulmonary Disease (COPD) and Osteoporosis

NCT01067248 | Completed

• 1 other identifier: M09-1971
• Study Type: observational
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pulmonary Disease, Chronic Obstructive; Osteoporosis

Keywords

COPD; Osteoporosis; Pathophysiology; Mechanism; Bone markers; Bone turnover; Protein turnover; Ageing; Endocrinology; Vitamin D

Study Arms (1)

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.

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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;
• Capable to provide informed consent.

You may not qualify if:

• 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 & Collaborators

• Catharina Ziekenhuis Eindhoven: lead
• Maastricht University Medical Center: collaborator
• Center for Integrated Rehabilitation and Organ Failure Horn: collaborator

Biospecimen

Retention: SAMPLES WITH DNA

Markers of ageing, such as telomere length and sirtuin 1.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Osteoporosis

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Emiel Wouters, MD, PhD, prof

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: February 10, 2010
• First Posted: February 11, 2010
• Study Start: January 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: July 29, 2015

Record last verified: 2015-07