Trial Acronym POPS
Clinical Area Musculoskeletal
Description Prevention and Treatment of Steroid-Induced Osteopaenia in Children And Adolescents With Rheumatic Diseases (On Behalf of BSPAR).
Status Analysis and Reporting
Date Opened to Recruitment August 2007
Target Recruitment 216
Recruitment to date 216 (Completed)
Trial Design A multicentre double-blinded randomised placebo-controlled trial. Patients will be recruited and followed for a period of one year. They will be randomised to take one of two active treatments or placebo.
Study Aim Primary objective of this study is to demonstrate whether 1-hydroxycholecalciferol or the Bisphosphonate Risedronate is superior to placebo in preventing osteopaenia in children with rheumatic diseases commencing or established on steroids.
Primary Endpoint – The primary measure of efficacy is change in bone mineral density measured by DEXA at one year.
SecondaryEndpoint – The secondary outcome measure is: Fracture rate during the trial period.
Chief Investigator Professor Madeleine Rooney
Sponsor Belfast Health and Social Care Trust
Funder Arthritis Research UK