NCT00384306

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for phase_1 chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Jun 2004

Typical duration for phase_1 chronic-obstructive-pulmonary-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 4, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 6, 2006

Completed
Last Updated

April 16, 2015

Status Verified

April 1, 2015

Enrollment Period

1.6 years

First QC Date

October 4, 2006

Last Update Submit

April 15, 2015

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPDprednisolonebone biopsytetracycline labelling

Outcome Measures

Primary Outcomes (1)

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

    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

    All measured with and without 3 weeks dosing with oral prednisolone

Interventions

prednisoloneDRUG

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Females subjects must be unable to have children.
  • BMI 19 - 29.9
  • Non-smokers, ex-smokers or current light smokers (\<10 cigarettes/day)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GSK Clinical Trials Call Centre

Cambridge, CB2 2GG, United Kingdom

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Prednisolone

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • GSK Clinical Trials, MD

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 4, 2006

First Posted

October 6, 2006

Study Start

June 1, 2004

Primary Completion

January 1, 2006

Study Completion

January 1, 2006

Last Updated

April 16, 2015

Record last verified: 2015-04

Locations

GB(1)