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

Authors
Category Primary study
Registry of TrialsEU Clinical Trials Register
Year 2008
INTERVENTION: Trade Name: Aclasta 5mg solution for infusion Product Name: Aclasta Product Code: ZOL446H Pharmaceutical Form: Solution for infusion Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use CONDITION: Bone loss in patients with Multiple Sclerosis (MS) who require large short term doses of methylprednisolone for exacerbations of their disease. ; MedDRA version: 9.1 Level: LLT Classification code 10048393 Term: Multiple sclerosis relapse ; MedDRA version: 9.1 Level: LLT Classification code 10065687 Term: Bone loss PRIMARY OUTCOME: Main Objective: Patients with MS who are experiencing an exacerbation of their disease symptoms are traditionally treated with either a 3 day course of intravenous high dose corticosteroids (methylprednisolone) or sometimes a 5 day course of oral corticosteroids (methylprednisolone).The principal objective is to discover whether giving a single intravenous infusion of a bisphosphonate, zoledronate, immediately prior to the corticosteroid therapy will prevent the bone thinning effect of the steroid and the associated increase in fracture risk.; Primary end point(s): The hypothesis is that a single zoledronate infusion prior to a course of corticosteroid will prevent the rapid increase in bone resorption which normally occurs in response to high dose steroid therapy. The primary outcome will be a significant difference in serum CTX according to treatment group at day 7 the study. Secondary Objective: The secondary objective is to discover whether those patients given zoledronate had a prolonged period of protection for their bones, therefore reducing their risk of fracture. INCLUSION CRITERIA: Age 18‐65 with established MS Acute flare‐up requiring treatment with a corticosteroid Able to attend for study investigations and assessments Willing and able to provide informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Epistemonikos ID: 31057e0586bb5b5f090c092d7e13c781c6402ac1
First added on: Mar 31, 2022