Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Novartis
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
