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
Conditions
Interventions
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
Sponsors
North Bristol Trust
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: Previous diagnosis of osteoporosis Bone active therapy within previous 12 months (excluding calcium and low dose vitamin D), previous treatment with bisphosphonate at any time. Associated disorder which may influence bone metabolism Moderate to severe renal impairment (creatinine>150) Cardiac failure Possibility of pregnancy Breast feeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. ;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.;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. | — |
Countries
United Kingdom
Outcome results
None listed