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

Sponsor:	GlaxoSmithKline
Collaborator:	University of Cambridge
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00384306

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

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
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.

Resource links provided by NLM:

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

Drug Information available for: Prednisolone Prednisolone acetate Depo-medrol Medrol veriderm Methylprednisolone Prednisolone sodium phosphate Prednisolone Sodium Succinate Methylprednisolone Sodium Succinate Methylprednisolone hemisuccinate 6-Methylprednisolone

U.S. FDA Resources

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

No publications provided

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

Keywords provided by GlaxoSmithKline:

COPD
prednisolone
bone biopsy
tetracycline labelling

Additional relevant MeSH terms:

Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Methylprednisolone acetate
Prednisolone acetate
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions

Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents

ClinicalTrials.gov processed this record on February 09, 2012