NCT01001715

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Back Pain

Interventions

Type	Name	Description
DRUG	REGN475/SAR164877	Pharmaceutical form: solution Route of administration: intravenous infusion over 30 minutes
DRUG	Placebo (for REGN475/SAR164877)	Pharmaceutical form: solution Route of administration: intravenous infusion over 30 minutes

Timeline

• Start date: 2009-11-01
• Primary completion: 2011-01-01
• Completion: 2011-01-01
• First posted: 2009-10-27
• Last updated: 2013-05-27

Locations

11 sites across 1 country: United States