Zoledronic Acid in MS-patients With Osteoporosis

Phase 3TerminatedNCT01166178

Novartis29 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Osteoporosis Multiple Sclerosis

Interventions

Zoledronic AcidDRUG

Zoledronic acid 5 mg once a year via intravenous infusion

PlaceboDRUG

Placebo to zoledronic acid once a year via intravenous infusion

Calcium and Vitamin D combinationDIETARY_SUPPLEMENT

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion: * 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 * Other protocol-defined inclusion/exclusion criteria may apply

Locations (15)

Novartis Investigative Site

Bamberg, Germany

Novartis Investigative Site

Berlin, Germany

Novartis Investigative Site

Bochum, Germany

Outcomes

Primary Outcomes

Change in Bone Mineral Density of the Lumbar Spine at 12 Months

Change in bone mineral density (BMD) of the lumbar spine was measured using Dual X-ray Absorptiometry (DXA) at screening and at month 12. A DXA scanner is a device that uses x-ray beams to measure the amount of minerals in the bone.

Time frame: Screening (day -21 to -1) and month 12

Change in Bone Mineral Density of the Total Hip Region at 12 Months

Change in bone mineral density (BMD) of the total hip region was measured using Dual X-ray Absorptiometry (DXA) at screening and at month 12. A DXA scanner is a device that uses x-ray beams to measure the amount of minerals in the bone.

Time frame: Screening (day -21 to -1) and month 12

Secondary Outcomes

Change in Bone Mineral Density of the Lumbar Spine at 6 Months

Change in bone mineral density (BMD) of the lumbar spine was measured using Dual X-ray Absorptiometry (DXA) at screening and at month 6. A DXA scanner is a device that uses x-ray beams to measure the amount of minerals in the bone.

Time frame: Screening (day -21 to -1) and month 6

Change in Bone Mineral Density of the Femoral Neck at 6 Months

Change in bone mineral density (BMD) of the femoral neck was measured using Dual X-ray Absorptiometry (DXA) at screening and at month 6. A DXA scanner is a device that uses x-ray beams to measure the amount of minerals in the bone.

Time frame: Screening (day -21 to -1) and month 6

Change in Bone Mineral Density of the Total Hip at 6 Months

Change in bone mineral density (BMD) of the total hip was measured using Dual X-ray Absorptiometry (DXA) at screening and at month 6. A DXA scanner is a device that uses x-ray beams to measure the amount of minerals in the bone.

Time frame: Screening (day -21 to -1) and month 6

Data from ClinicalTrials.gov

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