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

Verified by: GlaxoSmithKline, November 2007
First Received: October 4, 2006 | Last Updated: November 7, 2007 | Phase: Phase 1 | Start Date: June 2004
Overall Status: Completed | Estimated Enrollment: 9
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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)...

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.”

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: Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

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 Investigator Information

Lead Investigator: GlaxoSmithKline Industry

Overall Clinical Trial Officials and Contacts

GSK Clinical Trials, MD Study Director GlaxoSmithKline  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

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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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00384306