E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Bone loss in patients with Multiple Sclerosis (MS) who require large short term doses of methylprednisolone for exacerbations of their disease. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10048393 |
E.1.2 | Term | Multiple sclerosis relapse |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10065687 |
E.1.2 | Term | Bone loss |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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.
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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E.4 | Principal 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
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E.5 End points |
E.5.1 | 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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The end of the trial is when the last subject recruited has had his last visit and assessment. The design of the study is such that there is an overlap of subject participation and study analysis, so that the study will not end before the last subject has completed his last visit. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |