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

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.”

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

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

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

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