Zoledronic Acid in MS-patients With Osteoporosis

Phase 3

Terminated

Conditions: Osteoporosis
Multiple Sclerosis

Interventions: Drug: Placebo
Drug: Zoledronic Acid
Dietary Supplement: Calcium and Vitamin D combination

Registration Number: NCT01166178

Lead Sponsor: Novartis

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: Not available

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 29

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Zoledronic Acid	Calcium and Vitamin D combination	Participants received zoledronic acid infusion in addition to calcium and vitamin D
Placebo	Placebo	Participants received placebo to zoledronic acid infusion in addition to calcium and vitamin D
Placebo	Calcium and Vitamin D combination	Participants received placebo to zoledronic acid infusion in addition to calcium and vitamin D
Zoledronic Acid	Zoledronic Acid	Participants received zoledronic acid infusion in addition to calcium and vitamin D

Primary Outcome Measures

Name	Time	Method
Change in Bone Mineral Density of the Lumbar Spine at 12 Months	Screening (day -21 to -1) and month 12	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.
Change in Bone Mineral Density of the Total Hip Region at 12 Months	Screening (day -21 to -1) and month 12	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.

Secondary Outcome Measures

Name	Time	Method
Change in Bone Mineral Density of the Lumbar Spine at 6 Months	Screening (day -21 to -1) and month 6	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.
Change in Bone Mineral Density of the Femoral Neck at 6 Months	Screening (day -21 to -1) and month 6	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.
Change in Bone Mineral Density of the Total Hip at 6 Months	Screening (day -21 to -1) and month 6	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.
Change in Bone Mineral Density of the Femoral Neck at 12 Months	Screening (day -21 to -1) and month 12	Change in bone mineral density (BMD) of the femoral neck 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.
Change in Bone Mineral Density of the Lumbar Spine at 24 Months	Screening (day -21 to -1) and month 24	Change in bone mineral density (BMD) of the lumbar spine was measured using Dual X-ray Absorptiometry (DXA) at screening and at month 24. A DXA scanner is a device that uses x-ray beams to measure the amount of minerals in the bone.
Change in Bone Mineral Density of the Total Hip Region at 24 Months	Screening (day -21 to -1) and month 24	Change in bone mineral density (BMD) of the total hip region was measured using Dual X-ray Absorptiometry (DXA) at screening and at month 24. A DXA scanner is a device that uses x-ray beams to measure the amount of minerals in the bone.
Change in Bone Mineral Density of the Femoral Neck at 24 Months	Screening (day -21 to -1) and month 24	Change in bone mineral density (BMD) of the femoral neck was measured using Dual X-ray Absorptiometry (DXA) at screening and at month 24. A DXA scanner is a device that uses x-ray beams to measure the amount of minerals in the bone.
Course of Disease in Multiple Sclerosis Patients	Screening (day -21 to -1) and month 12	The course of disease in Multiple Sclerosis (MS) patients was measured comparing results from the Expanded Disability Status Scale (EDSS) from screening and month 12. EDSS is a scale, ranging from 0 (normal) to 10 (death due to MS) for assessing neurologic impairment in MS. It is based on a weighting scheme of eight functional systems. The functional systems are Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel\&Bladder, Cerebral and Other functions. EDSS was assessed by the treating neurologist.
Adverse Events and Serious Adverse Events Comparison of Treatment Groups	24 months	Adverse Events and Serious Adverse events are reported in the safety section.