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)...
Date First Received: October 4, 2006
Last Updated: November 7, 2007
Verified by: GlaxoSmithKline, November 2007
Clinical Trial Phase: Phase 1 | Start Date: June 2004
Overall Status: Completed
Estimated Enrollment: 9
Brief Summary
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.”
Condition Keyword(s):
Intervention(s):
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
Intervention(s) in this Clinical Trial
- Drug: prednisolone
Outcome Measures for this Clinical Trial
Primary Measures
- Mineral apposition rate
Mineralising surface
Eroded surface
Bone formation rate
Osteocalcin levels
Serum and urinary deoxypyridinoline
- Time Frame: All measured with and without 3 weeks dosing with oral prednisolone
- Time Frame: All measured with and without 3 weeks dosing with oral prednisolone
Secondary Measures
- Pharmacokinetic measurements
Bone structure and micro computer tomography of bone biopsies
Biochemical markers of bone formation, bone break down and hormones
- Time Frame: All measured with and without 3 weeks dosing with oral prednisolone
- Time Frame: All measured with and without 3 weeks dosing with oral prednisolone
Criteria for Participation in this Clinical Trial
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)
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 40 Years
Maximum Age for this Clinical Trial: 75 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: GlaxoSmithKline
Overall Clinical Trial Officials and Contacts
GSK Clinical Trials, MD Study Director GlaxoSmithKline
Additional Information
Information obtained from ClinicalTrials.gov on July 02, 2009
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
Clinical Trials Authorship and Review
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