Effects Of Oral Prednisolone On Bone Metabolism In Patients With Chronic Obstructive Pulmonary Disease
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
prednisolone
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD, prednisolone, bone biopsy, tetracycline labelling
Eligibility 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)
Sites / Locations
- GSK Clinical Trials Call Centre
Outcomes
Primary Outcome Measures
Mineral apposition rate Mineralising surface Eroded surface Bone formation rate Osteocalcin levels Serum and urinary deoxypyridinoline
Secondary Outcome Measures
Pharmacokinetic measurements Bone structure and micro computer tomography of bone biopsies Biochemical markers of bone formation, bone break down and hormones
Full Information
NCT ID
NCT00384306
First Posted
October 4, 2006
Last Updated
April 15, 2015
Sponsor
GlaxoSmithKline
Collaborators
University of Cambridge
1. Study Identification
Unique Protocol Identification Number
NCT00384306
Brief Title
Effects Of Oral Prednisolone On Bone Metabolism In Patients With 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 Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
January 2006 (Actual)
Study Completion Date
January 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
GlaxoSmithKline
Collaborators
University of Cambridge
4. Oversight
5. Study Description
Brief Summary
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
COPD, prednisolone, bone biopsy, tetracycline labelling
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
prednisolone
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials, MD
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Clinical Trials Call Centre
City
Cambridge
ZIP/Postal Code
CB2 2GG
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Effects Of Oral Prednisolone On Bone Metabolism In Patients With Chronic Obstructive Pulmonary Disease
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