Effects Of Oral Prednisolone On Bone Metabolism In Patients With Chronic Obstructive Pulmonary Disease - Full Text View

Purpose

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).

Condition	Intervention	Phase
Chronic Obstructive Pulmonary Disease	Drug: prednisolone	Phase I

MedlinePlus related topics:

COPD (Chronic Obstructive Pulmonary Disease)

Drug Information available for:

Prednisolone 6-Methylprednisolone Depo-medrol Medrol veriderm Methylprednisolone Methylprednisolone hemisuccinate Methylprednisolone Sodium Succinate Prednisolone acetate Prednisolone sodium phosphate Prednisolone Sodium Succinate Tetracycline Tetracycline hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Crossover Assignment, Pharmacodynamics Study

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.

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

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 Measures:

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 ]

Enrollment:	9
Study Start Date:	June 2004
Study Completion Date:	January 2006

Eligibility

Ages Eligible for Study:	40 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00384306

Locations


United Kingdom
	GSK Clinical Trials Call Centre
	Cambridge, United Kingdom, CB2 2GG

Sponsors and Collaborators

GlaxoSmithKline

University of Cambridge

Investigators


Study Director:	GSK Clinical Trials, MD	GlaxoSmithKline

More Information

Study ID Numbers:	RES11086
First Received:	October 4, 2006
Last Updated:	November 7, 2007
ClinicalTrials.gov Identifier:	NCT00384306
Health Authority:	United Kingdom: Research Ethics Committee

Keywords provided by GlaxoSmithKline:

COPD

prednisolone

bone biopsy

tetracycline labelling

Study placed in the following topic categories:

Lung Diseases, Obstructive

Respiratory Tract Diseases

Methylprednisolone

Lung Diseases

Prednisolone

Methylprednisolone acetate

Prednisolone acetate

Tetracycline

Methylprednisolone Hemisuccinate

Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:

Anti-Inflammatory Agents

Antineoplastic Agents, Hormonal

Antineoplastic Agents

Physiological Effects of Drugs

Gastrointestinal Agents

Hormones, Hormone Substitutes, and Hormone Antagonists

Antiemetics

Protective Agents

Neuroprotective Agents

Glucocorticoids

Hormones

Pharmacologic Actions

Autonomic Agents

Therapeutic Uses

Peripheral Nervous System Agents

Central Nervous System Agents

ClinicalTrials.gov processed this record on October 29, 2008

Sponsors and Collaborators:	GlaxoSmithKline University of Cambridge
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00384306