Status:
TERMINATED
Zoledronic Acid in MS-patients With Osteoporosis
Lead Sponsor:
Novartis
Conditions:
Osteoporosis
Multiple Sclerosis
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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 optim...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT01166178
Start Date
October 1 2010
End Date
June 1 2012
Last Update
November 26 2013
Active Locations (15)
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1
Novartis Investigative Site
Bamberg, Germany
2
Novartis Investigative Site
Berlin, Germany
3
Novartis Investigative Site
Bochum, Germany
4
Novartis Investigative Site
Hamburg, Germany