Official Title: “Investigation of the Side Effects of Orally Administered Glucocorticoids. An Open Label Study to Investigate the Effects of Orally Administered Prednisolone on Bone Metabolism in Patients With COPD.”

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).

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Crossover Assignment, Pharmacodynamics Study

Primary:

• 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:

• 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

Inclusion criteria:

• Females subjects must be unable to have children.
• BMI 19 - 29.9
• Non-smokers, ex-smokers or current light smokers (<10 cigarettes/day)

Exclusion criteria:

• High blood pressure
• Other significant disease
• Use of certain medications (to be decided by the investigator)

Lead Sponsor: GlaxoSmithKline

GSK Clinical Trials Call Centre

Cambridge  CB2 2GG United Kingdom

Overall Clinical Trial Officials and Contacts

GSK Clinical Trials, MD Study Director GlaxoSmithKline  

Information obtained from ClinicalTrials.gov on July 18, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00384306

Study ID Number: RES11086

ClinicalTrials.gov Identifier: NCT00384306

Health Authority: United Kingdom: Research Ethics Committee