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OpenTrials
Completed

NCT Number: NCT00384306

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

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).

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

GSK Clinical Trials Call Centre

Cambridge, CB2 2GG, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Prednisolone

Drug

Primary outcomes

  1. 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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Collaborators

  • University of Cambridge

Registry information

Official study 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.

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Oct 6, 2006
Registry last updated
Apr 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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