POPS

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

RECRUITMENT

Date Opened to Recruitment	August 2007
Target Recruitment	216
Recruitment to date	216 (Completed)

TRIAL DESIGN

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 (CI)

Chief Investigator

Professor Madeleine Rooney

SPONSOR(s) & FUNDER(s)

Sponsor	Belfast Health and Social Care Trust
Funder	Arthritis Research UK