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

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.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00384306

Enrollment

Registered

2006-10-06

Start date

2004-06-30

Completion date

2006-01-31

Last updated

2015-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD, prednisolone, bone biopsy, tetracycline labelling

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).

Interventions

DRUGprednisolone

Study design

Allocation

NON_RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

40 Years to 75 Years

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)

Design outcomes

Primary

Measure	Time frame
Mineral apposition rate Mineralising surface Eroded surface Bone formation rate Osteocalcin levels Serum and urinary deoxypyridinoline	All measured with and without 3 weeks dosing with oral prednisolone

Secondary

Measure	Time frame
Pharmacokinetic measurements Bone structure and micro computer tomography of bone biopsies Biochemical markers of bone formation, bone break down and hormones	All measured with and without 3 weeks dosing with oral prednisolone

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026