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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 1

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Drug: prednisolone

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00384306

RES11086

Details and patient eligibility

About

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).

Enrollment: 9 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)