Osteoporosis and Chronic Obstructive Pulmonary Disease (COPD)

COPD Clinical Trial

Official title:

Osteoporosis and COPD (Making of a Database)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00231127
• Other study ID #: M05-1522
• Status: Completed
• Phase: N/A
• First received: October 3, 2005
• Last updated: November 9, 2009
• Start date: April 2005
• Est. completion date: January 2009

Study information

• Verified date: November 2009
• 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 goals of the trial are:

• To determine the prevalence of osteoporosis in subgroups of COPD patients.

• To look for risk factors of osteoporosis in COPD patients.

• To create sub-groups for prospective research concerning the effects of bisphosphonates on osteoporosis variables in COPD patients.

Description:

Background:

Osteoporosis is defined as a systemically skeletal disorder characterized by a low bone mass and deterioration of the micro-architecture of the bone and is therefore associated with a higher risk of fractures. Large epidemiological studies to determine the incidence and prevalence of osteoporosis in COPD patients in different stages of their disease are not available. The etiology of osteoporosis in COPD patients is complex and depends on multiple factors.

Goals of the Trial:

• To determine the prevalence of osteoporosis in subgroups of COPD patients.

• To look for risk factors of osteoporosis in COPD patients.

• To create sub-groups for prospective research concerning the effects of bisphosphonates on osteoporosis variables in COPD patients.

Study Design:

Patients diagnosed with COPD (according to the American Thoracic Society [ATS] guidelines and divided in stages according to the Global Initiative on Obstructive Lung Diseases [GOLD]-classification) who visit the out-patient clinic of pulmonology of the Catharina Hospital Eindhoven will be asked to participate in the trial. A database will be created (prospectively) of the (medical) information about these patients, which will be analysed retrospective. To gather information we will use the medical records, a questionnaire, a blood sample, long function testing including a 6-minute walking test and a DEXA-scan.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age > 18 years

• Men and women

• COPD according to the ATS-guidelines, divided in severity according to the GOLD criteria

• Written consent

Exclusion Criteria:

• Age < 18 years

• No written consent

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• COPD
• Osteopenia
• Osteoporosis
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
Netherlands	Catharina Hospital Eindhoven	Eindhoven	Noord-Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Catharina Ziekenhuis Eindhoven

Country where clinical trial is conducted

Netherlands,