Zoledronate in Multiple Sclerosis

• Research type

  Research Study

• Full title

  A Randomised Control Trial (RCT) To Evaluate Whether Zoledronate Prevents Bone Loss In Acute Exacerbations Of Multiple Sclerosis

• Sponsor organisation

  North Bristol Trust

• Eudract number

  2008-005304-93

• ISRCTN Number

  87039596

• Research summary

  The study is to determine whether a single intravenous(IV) infusion of zoledronate 5mg would be effective at preventing bone loss and risk of fractures in multiple sclerosis(MS) patients with a worsening of their symptoms requiring treatment with short term high dose corticosteroids such as methylprednisolone 1g IV for 3 days or 500mg orally for 5 days. High dose corticosteroid therapy is associated with increased fracture risk. 40 patients presenting at neurology out patients with worsening symptoms will be recruited into the study. They will be randomised into the intervention group and the placebo group. They will know which group they are in.All patients will receive an infusion of either zoledronate 5mg or a placebo prior to their corticosteroid therapy. Blood samples to measure changes in bone markers will be taken on Days 0,1,2,7,90,180 and 360.All patients will have a dual energy x-ray absorptiometry (DXA)on day 7 (or as close to day 7 as possible) from starting corticosteroids and on days 90,180 and 360.

• REC name

  South West - Cornwall & Plymouth Research Ethics Committee

• REC reference

  08/H0206/76

• Date of REC Opinion

  13 Feb 2009

• REC opinion

  Further Information Favourable Opinion