Back Pain Clinical Trial
Official title:
Randomized, Double-blind, Placebo-controlled Study of the Effect of a Single Injection of SAR164877 (REGN475) on Reduction of Pain From Vertebral Fracture Associated With Osteoporosis
Primary objective was to demonstrate the activity of REGN475/SAR164877 in reducing the pain
associated with vertebral fracture.
Secondary objectives were:
- to assess the safety and tolerability of REGN475/SAR164877 in patients with vertebral
fracture pain;
- to characterize the pharmacokinetic and immunogenicity profiles of REGN475/SAR164877 in
this population.
The duration of the study period for each participant was up to 13 weeks, including a screening period up to 5 days, and 12-week follow-up after the injection. ;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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