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Zoledronic Acid in MS-patients With Osteoporosis (EXALT)

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Novartis

Status and phase

Terminated
Phase 3

Conditions

Osteoporosis
Multiple Sclerosis

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT01166178
CZOL446HDE40
2009-011888-37 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

29 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Quadruple Blind

29 participants in 2 patient groups, including a placebo group

Zoledronic Acid
Experimental group
Description:
Participants received zoledronic acid infusion in addition to calcium and vitamin D
Treatment:
Dietary Supplement: Calcium and Vitamin D combination
Drug: Zoledronic Acid
Placebo
Placebo Comparator group
Description:
Participants received placebo to zoledronic acid infusion in addition to calcium and vitamin D
Treatment:
Dietary Supplement: Calcium and Vitamin D combination
Drug: Placebo

Trial contacts and locations

15

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Data sourced from clinicaltrials.gov

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