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Zoledronic Acid in MS-patients With Osteoporosis

NCT ID: NCT01166178

Last Updated: 2013-11-26

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2012-06-30

Brief Summary

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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

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Conditions

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Osteoporosis Multiple Sclerosis

Keywords

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Multiple Sclerosis Osteoporosis Zoledronic Acid

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Zoledronic Acid

Participants received zoledronic acid infusion in addition to calcium and vitamin D

Group Type EXPERIMENTAL

Zoledronic Acid

Intervention Type DRUG

Zoledronic acid 5 mg once a year via intravenous infusion

Calcium and Vitamin D combination

Intervention Type DIETARY_SUPPLEMENT

Calcium 500 mg and Vitamin D 400 IU combined tablet, taken orally twice a day

Placebo

Participants received placebo to zoledronic acid infusion in addition to calcium and vitamin D

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo to zoledronic acid once a year via intravenous infusion

Calcium and Vitamin D combination

Intervention Type DIETARY_SUPPLEMENT

Calcium 500 mg and Vitamin D 400 IU combined tablet, taken orally twice a day

Interventions

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Zoledronic Acid

Zoledronic acid 5 mg once a year via intravenous infusion

Intervention Type DRUG

Placebo

Placebo to zoledronic acid once a year via intravenous infusion

Intervention Type DRUG

Calcium and Vitamin D combination

Calcium 500 mg and Vitamin D 400 IU combined tablet, taken orally twice a day

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Written informed consent to participate in the trial
* Definite diagnosis of Multiple Sclerosis (MS) as defined by 2005 revised McDonald criteria
* MS-subtype: Relapsing-remitting MS (RRMS), Secondary progressive MS (SPMS), Primary progressive MS (PPMS)
* Expanded Disability Status Scale (Kurtzke's scale; EDSS) score between 2.5 to 6.5 (including both)
* Bone mineral density (BMD) T-score of less or equal to -2.0 and more or equal to -4.0 at the lumbar spine (L1-L4 with at least 2 evaluable vertebrae) and/or total hip region and/or femoral neck in recent Dual X-Ray Absorptiometry (DXA)-scan (\< or = 3 months)
* Sufficient ability to read, write and communicate comprehensibly and comply to study procedures
* No immunomodulatory treatment for MS within the last 30 days or stable and well tolerated therapy with any beta-interferon formulation, or glatirameracetate or fingolimod for at least 30 days immediately prior to baseline

Exclusion Criteria

* Contraindications against Calcium and Vitamin D and zoledronic acid according to the summary product characteristics
* More than one osteoporotic fracture
* Concomitant medication with influence on bone mineral density (eg. enzyme- inducing antiepileptics like Carbamazepin, Phenytoin, Phenobarbital, Primidon)
* Any neurological disorder other than MS which is known to affect bone mineral density (e.g. muscular dystrophy, severe paresis for other reasons than MS, degenerative nervous disorder, stroke)
* Women who are pregnant or breast feeding, or menstruating and capable of becoming pregnant.
* Baseline renal insufficiency
* 25-OH vitamin D level \< 10 ng/ml at screening
* Serum calcium levels \> 2.75 mmol/l (11.0 mg/dL) or \< 2.00 mmol/L (8.0 mg/dL) at screening
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Bamberg, , Germany

Site Status

Novartis Investigative Site

Berlin, , Germany

Site Status

Novartis Investigative Site

Bochum, , Germany

Site Status

Novartis Investigative Site

Hamburg, , Germany

Site Status

Novartis Investigative Site

Heidelberg, , Germany

Site Status

Novartis Investigative Site

Kassel, , Germany

Site Status

Novartis investigative site

Leipzig, , Germany

Site Status

Novartis Investigative Site

Leverkusen, , Germany

Site Status

Novartis investigative site

Ludwigshafen, , Germany

Site Status

Novartis investigative site

Magdeburg, , Germany

Site Status

Novartis investigative site

München, , Germany

Site Status

Novartis investigative site

Nümbrecht, , Germany

Site Status

Novartis investigative site

Oldenburg, , Germany

Site Status

Novartis Investigative Site

Siegen, , Germany

Site Status

Novartis investigative site

Stade, , Germany

Site Status

Countries

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Germany

Other Identifiers

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2009-011888-37

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CZOL446HDE40

Identifier Type: -

Identifier Source: org_study_id