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 ...

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Reference: EUCTR2009-011888-37

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

Woman and Man

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Extract

To demonstrate that zoledronic acid has superior efficacy compared with placebo on the percent change of bone mineral density (BMD) as assessed by the T-score at lumbar spine and total hip region at month 12 relative to screening as measured by Dual X-ray Absorptiometry (DXA) in MS patients suffering from osteoporosis.


Inclusion criteria

  • osteoporosis in patients with multiple sclerosis

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