Conditions: Osteoporosis Multiple Sclerosis
Keywords: Multiple Sclerosis Osteoporosis Zoledronic Acid
Allocation: RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 29
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: Participants received zoledronic acid infusion in addition to calcium and vitamin D arm 2: Participants received placebo to zoledronic acid infusion in addition to calcium and vitamin D

Interventions: intervention 1: Zoledronic Acid intervention 2: Placebo intervention 3: Calcium and Vitamin D combination
Intervention descriptions: intervention 1: Zoledronic acid 5 mg once a year via intravenous infusion intervention 2: Placebo to zoledronic acid once a year via intravenous infusion intervention 3: Calcium 500 mg and Vitamin D 400 IU combined tablet, taken orally twice a day

Protocol document: