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

GlaxoSmithKline9 enrolled

Overview

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

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

prednisoloneDRUG

Eligibility

Sex: ALLMin age: 40 YearsMax age: 75 Years

Medical Language ↔ Plain English

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)

Locations (1)

GSK Clinical Trials Call Centre

Cambridge, United Kingdom

Outcomes

Primary Outcomes

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 Outcomes

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

Data from ClinicalTrials.gov

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