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

Condition(s) targeted: Chronic Obstructive Pulmonary Disease

Intervention: prednisolone (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Director, Affiliation: GlaxoSmithKline

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).

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.

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

Primary outcome: Mineral apposition rate Mineralising surface Eroded surface Bone formation rate Osteocalcin levels Serum and urinary deoxypyridinoline

Secondary outcome: Pharmacokinetic measurements Bone structure and micro computer tomography of bone biopsies Biochemical markers of bone formation, bone break down and hormones

Minimum age: 40 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

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)

GSK Clinical Trials Call Centre, Cambridge CB2 2GG, United Kingdom

Starting date: June 2004
Ending date: January 2006
Last updated: November 7, 2007