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.
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Primary Endpoint – The primary measure of efficacy is change in bone mineral density measured by DEXA at one year. |
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SecondaryEndpoint – The secondary outcome measure is: Fracture rate during the trial period. |