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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

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

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

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

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