Zoledronic Acid in MS-patients With Osteoporosis (EXALT)
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ClinicalTrials.gov Identifier: NCT01166178 |
Recruitment Status :
Terminated
First Posted : July 20, 2010
Results First Posted : November 26, 2013
Last Update Posted : November 26, 2013
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Condition or disease | Intervention/treatment | Phase |
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Osteoporosis Multiple Sclerosis | Drug: Zoledronic Acid Drug: Placebo Dietary Supplement: Calcium and Vitamin D combination | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 29 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Study Start Date : | October 2010 |
Actual Primary Completion Date : | June 2012 |
Actual Study Completion Date : | June 2012 |

Arm | Intervention/treatment |
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Experimental: Zoledronic Acid
Participants received zoledronic acid infusion in addition to calcium and vitamin D
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Drug: Zoledronic Acid
Zoledronic acid 5 mg 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 |
Placebo Comparator: Placebo
Participants received placebo to zoledronic acid infusion in addition to calcium and vitamin D
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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 |
- Change in Bone Mineral Density of the Lumbar Spine at 12 Months [ Time Frame: 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 [ Time Frame: 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.
- Change in Bone Mineral Density of the Lumbar Spine at 6 Months [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 24 months ]Adverse Events and Serious Adverse events are reported in the safety section.

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01166178
Germany | |
Novartis Investigative Site | |
Bamberg, Germany | |
Novartis Investigative Site | |
Berlin, Germany | |
Novartis Investigative Site | |
Bochum, Germany | |
Novartis Investigative Site | |
Hamburg, Germany | |
Novartis Investigative Site | |
Heidelberg, Germany | |
Novartis Investigative Site | |
Kassel, Germany | |
Novartis investigative site | |
Leipzig, Germany | |
Novartis Investigative Site | |
Leverkusen, Germany | |
Novartis investigative site | |
Ludwigshafen, Germany | |
Novartis investigative site | |
Magdeburg, Germany | |
Novartis investigative site | |
Muenchen, Germany | |
Novartis investigative site | |
Numbrecht, Germany | |
Novartis investigative site | |
Oldenburg, Germany | |
Novartis Investigative Site | |
Siegen, Germany | |
Novartis investigative site | |
Stade, Germany |
Study Director: | Novartis Pharmceuticals | Novartis Pharmaceuticals |
Responsible Party: | Novartis |
ClinicalTrials.gov Identifier: | NCT01166178 |
Other Study ID Numbers: |
CZOL446HDE40 2009-011888-37 ( EudraCT Number ) |
First Posted: | July 20, 2010 Key Record Dates |
Results First Posted: | November 26, 2013 |
Last Update Posted: | November 26, 2013 |
Last Verified: | October 2013 |
Multiple Sclerosis Osteoporosis Zoledronic Acid |
Osteoporosis Multiple Sclerosis Sclerosis Pathologic Processes Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases Bone Diseases, Metabolic |
Bone Diseases Musculoskeletal Diseases Metabolic Diseases Vitamin D Zoledronic Acid Calcium Vitamins Micronutrients Physiological Effects of Drugs Calcium-Regulating Hormones and Agents Bone Density Conservation Agents |