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

This study has been completed.
University of Cambridge
Information provided by:
GlaxoSmithKline Identifier:
First received: October 4, 2006
Last updated: April 15, 2015
Last verified: April 2015
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
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:

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
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   40 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00384306

United Kingdom
GSK Clinical Trials Call Centre
Cambridge, United Kingdom, CB2 2GG
Sponsors and Collaborators
University of Cambridge
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information Identifier: NCT00384306     History of Changes
Other Study ID Numbers: RES11086
Study First Received: October 4, 2006
Last Updated: April 15, 2015

Keywords provided by GlaxoSmithKline:
bone biopsy
tetracycline labelling

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents processed this record on July 19, 2017