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

NCT ID: NCT00384306

Last Updated: 2015-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2006-01-31

Brief Summary

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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).

Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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prednisolone

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Cambridge

OTHER

Sponsor Role collaborator

GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Principal Investigators

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GSK Clinical Trials, MD

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Clinical Trials Call Centre

Cambridge, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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RES11086

Identifier Type: -

Identifier Source: org_study_id

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