Effects Of Oral Prednisolone On Bone Metabolism In Patients With Chronic Obstructive Pulmonary Disease

Phase 1

Completed

• Conditions: Chronic Obstructive Pulmonary Disease

• Registration Number: NCT00384306
• Lead Sponsor: GlaxoSmithKline

Brief Summary

The aim of this study is to establish associations between blood and urine markers of bone metabolism with histomorphometric changes (changes in the actual bone structure) resulting from short term oral prednisolone treatment in patients with COPD (chronic obstructive pulmonary disease).

Detailed Description

Not available

Study Timeline

• Study Start: 2004-06
• Primary Completion: 2006-01
• Study Completion: 2006-01
• Study First Submitted: 2006-10-04
• Study First Submitted QC: 2006-10-04
• Study First Posted: 2006-10-06
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-15
• Last Update Posted: 2015-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Mineral apposition rate Mineralising surface Eroded surface Bone formation rate Osteocalcin levels Serum and urinary deoxypyridinoline	All measured with and without 3 weeks dosing with oral prednisolone

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic measurements Bone structure and micro computer tomography of bone biopsies Biochemical markers of bone formation, bone break down and hormones	All measured with and without 3 weeks dosing with oral prednisolone

Trial Locations

Locations (1)

GSK Clinical Trials Call Centre; 🇬🇧 Cambridge, United Kingdom