NCT01166178

Zoledronic Acid in MS-patients With Osteoporosis

A 1-year, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy of Zoledronic Acid 5 mg (Aclasta®) on Bone Mineral Density in Patients With Multiple Sclerosis Followed by a 1-year Open-label Treatment Phase

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Osteoporosis
• Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	Zoledronic Acid	Zoledronic acid 5 mg once a year via intravenous infusion
DRUG	Placebo	Placebo to zoledronic acid once a year via intravenous infusion
DIETARY_SUPPLEMENT	Calcium and Vitamin D combination	Calcium 500 mg and Vitamin D 400 IU combined tablet, taken orally twice a day

Timeline

• Start date: 2010-10-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2010-07-20
• Last updated: 2013-11-26
• Results posted: 2013-11-26

Locations

15 sites across 1 country: Germany