Last updated: 11/04/2018 10:24:22

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

GSK study ID
RES11086
Clinicaltrials.gov ID
NCT00384306
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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.
Trial description: 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).
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

Mineral apposition rate Mineralising surface Eroded surface Bone formation rate Osteocalcin levels Serum and urinary deoxypyridinoline

Timeframe: All measured with and without 3 weeks dosing with oral prednisolone

Secondary outcomes:

Pharmacokinetic measurements Bone structure and micro computer tomography of bone biopsies Biochemical markers of bone formation, bone break down and hormones

Timeframe: All measured with and without 3 weeks dosing with oral prednisolone

Interventions:
  • Drug: prednisolone
    • Enrollment:
    9
    Primary completion date:
    2006-31-01
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Chronic obstructive pulmonary disease
    Product
    prednisolone
    Collaborators
    University of Cambridge
    Study date(s)
    June 2004 to January 2006
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    40 - 75 Years
    Accepts healthy volunteers
    No
    • Inclusion criteria:
    • Females subjects must be unable to have children.
    Inclusion and exclusion criteria
    Inclusion 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)

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Clinical Trials Call Centre
    Cambridge, N/A, United Kingdom, CB2 2GG
    Status
    Recruitment Complete
    Contact us

    Study documents

    No study documents available.

    Results overview

    Study Results yet to be posted

    Recruitment status
    Study complete
    Actual primary completion date
    2006-31-01
    Actual study completion date
    2006-31-01

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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