This study is designed to evaluate the efficacy and safety of zoledronic acid 5 mg
intravenous (i.v.) relative to placebo in Multiple Sclerosis (MS) patients with osteoporosis
and to support the optimal use of zoledronic acid for this indication. Primary objective is
the change of Bone Mineral Density (BMD) at lumbar spine (L1-L4) and total hip region
assessed by T-Score at month 12 relative to screening as measured by Dual X-ray
Absorptiometry (DXA). This double-blind period will be followed by a 52-week open-label
treatment phase to assess long-term efficacy and safety of zoledronic acid in these patients.
Phase:
Phase 3
Details
Lead Sponsor:
Novartis
Treatments:
Calcium Calcium, Dietary Diphosphonates Ergocalciferols Vitamin D Vitamins Zoledronic Acid