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CompletedNCT00384306Updated Apr 16, 2015

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

A Phase 1 interventional study of prednisolone in Chronic Obstructive Pulmonary Disease, sponsored by GlaxoSmithKline. Completed at 1 site in United Kingdom. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2015-04-16.

Sponsored by GlaxoSmithKline · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
9
Allocation
Non-randomized
Ages
40 Years to 75 Years
Sex
All
01

Study summary

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).

02

Conditions studied

  • Chronic Obstructive Pulmonary Disease

Keywords

  • COPD
  • prednisolone
  • bone biopsy
  • tetracycline labelling
03

In context

Lung Diseases

3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.

This study's enrollment of 9 is below the median of 72 across 2,118 interventional studies indexed under Lung Diseases.

Browse Lung Diseases studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 75 Years
Sexes eligible
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

Exclusion criteria:

  • High blood pressure
  • Other significant disease
  • Use of certain medications (to be decided by the investigator)
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
9 participants (actual)

Interventions

  • Drugprednisolone
06

What researchers measure

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

07

Study locations

1 site
  • GSK Clinical Trials Call Centre
    Cambridge, CB2 2GG, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 16, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00384306
Lead sponsor
GlaxoSmithKline
Collaborators
University of Cambridge
First posted
Oct 6, 2006
Start date
Jun 2004
Primary completion
Jan 2006
Completion
Jan 2006
Last update
Apr 16, 2015

Study contacts

GSK Clinical Trials, MD
study director · GlaxoSmithKline
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.

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