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Zoledronic Acid in MS-patients With Osteoporosis

NCT01166178 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2013-11-26

Study results available
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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

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2012-06-30
Completion
2012-06-30

Countries

  • Germany

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01166178 on ClinicalTrials.gov