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
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
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
Observational study model:
Not applicable
Primary completion date:
2006-31-01
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
- Females subjects must be unable to have children.
- BMI 19 - 29.9
- High blood pressure
- Other significant disease
Inclusion and exclusion 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
GSK Clinical Trials Call Centre
Cambridge, N/A, United Kingdom, CB2 2GG
Status
Recruitment Complete
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Completed
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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