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.

Study Overview

• Status: Terminated
• Conditions: Back Pain
• Intervention / Treatment: Drug: REGN475/SAR164877; Drug: Placebo (for REGN475/SAR164877)

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.

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Beverly Hills, California, United States, 90211
      • Sanofi-Aventis Investigational Site Number 840005
    • Fresno, California, United States, 93710
      • Sanofi-Aventis Investigational Site Number 840001
    • Sacramento, California, United States, 95817
      • Sanofi-Aventis Investigational Site Number 840017
    • San Diego, California, United States, 92103
      • Sanofi-Aventis Investigational Site Number 840028
    • Stockton, California, United States, 95204
      • Sanofi-Aventis Investigational Site Number 840008
  • Florida
    • Boynton Beach, Florida, United States, 33472
      • Sanofi-Aventis Investigational Site Number 840013
    • Clearwater, Florida, United States, 33755
      • Sanofi-Aventis Investigational Site Number 840047
  • Georgia
    • Atlanta, Georgia, United States, 30328
      • Sanofi-Aventis Investigational Site Number 840034
  • New York
    • New York, New York, United States, 11201
      • Sanofi-Aventis Investigational Site Number 840026
  • Texas
    • Fort Worth, Texas, United States, 76117
      • Sanofi-Aventis Investigational Site Number 840044
    • Southlake, Texas, United States, 76092
      • Sanofi-Aventis Investigational Site Number 840023

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: REGN475/SAR164877; REGN475/SAR164877, single injection, dose depending on the participant's body weight	Drug: REGN475/SAR164877; Pharmaceutical form: solution Route of administration: intravenous infusion over 30 minutes
Placebo Comparator: Placebo; Placebo (for REGN475/SAR164877), single injection	Drug: Placebo (for REGN475/SAR164877); Pharmaceutical form: solution Route of administration: intravenous infusion over 30 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change from baseline in pain intensity as assessed by Pain Intensity Numeric Rating Scale [PI-NRS]	The baseline value was defined as the average of PI-NRS values obtained at screening and at randomization visit. The Week 4 value was defined as the average of PI-NRS values obtained daily through e-Diary assessments during Week 4.	baseline and 4 weeks after injection

Secondary Outcome Measures

Outcome Measure	Time Frame
Mean change from baseline in pain intensity as assessed by PI-NRS	baseline and every other weeks up to 12 weeks after injection
Percentage of pain-free days (score "0" pain on PI-NRS)	12 weeks
Percentage of days with rescue analgesia use	12 weeks
Change from baseline in Quality of Life Questionnaire of the European Foundation for Osteoporosis [QUALEFFO] score	baseline and 4, 8, 12 weeks
Change from baseline in Short Form-12 Item Quality of Life Questionnaire [SF-12] score	baseline and 4, 8, 12 weeks
Patient Global Impression of Change [PGIC] score	4, 8, 12 weeks
Percentage of participants with at least 30% and 50% reduction from baseline in pain intensity	up to 12 weeks after injection
Pharmacokinetic: REGN475/SAR164877 serum concentration	12 weeks

Collaborators and Investigators

• Sponsor: Regeneron Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (Actual): January 1, 2011
• Study Completion (Actual): January 1, 2011

Study Registration Dates

• First Submitted: October 26, 2009
• First Submitted That Met QC Criteria: October 26, 2009
• First Posted (Estimate): October 27, 2009

Study Record Updates

• Last Update Posted (Estimate): May 27, 2013
• Last Update Submitted That Met QC Criteria: May 20, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Spinal Injuries; Back Injuries; Spinal Fractures; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Fasinumab
• Other Study ID Numbers: ACT11308