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

This study has been completed.
Sponsor:
Collaborator:
University of Cambridge
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00384306
First received: October 4, 2006
Last updated: November 7, 2007
Last verified: November 2007
History of Changes
  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 1

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:

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 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 May 22, 2013