Single Injection of REGN475/SAR164877 in Treatment of Vertebral Fracture Pain

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.

Inclusion criteria:

- Moderate to severe pain due to non-traumatic vertebral fracture associated with osteoporosis.

Exclusion criteria:

• Mild pain score on the Pain Intensity-Numeric Rating Scale [PI-NRS] at screening and randomization visits;
• Narcotic addiction;
• Post-fracture vertebral instability;
• Unwillingness to use study-defined rescue analgesia exclusively.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.