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

Phase 2

Terminated

• Conditions: Back Pain
• Interventions: Drug: REGN475/SAR164877; Drug: Placebo (for REGN475/SAR164877)

• Registration Number: NCT01001715
• Lead Sponsor: Regeneron Pharmaceuticals

Brief 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.

Study Timeline

• Study First Submitted: 2009-10-26
• Study First Submitted QC: 2009-10-26
• Study First Posted: 2009-10-27
• Study Start: 2009-11
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Disposition First Submitted: 2012-10-23
• Disposition First Submitted QC: 2012-10-23
• Disposition First Posted: 2012-10-30
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-20
• Last Update Posted: 2013-05-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
REGN475/SAR164877	REGN475/SAR164877	REGN475/SAR164877, single injection, dose depending on the participant's body weight
Placebo	Placebo (for REGN475/SAR164877)	Placebo (for REGN475/SAR164877), single injection

Primary Outcome Measures

Name	Time	Method
Mean change from baseline in pain intensity as assessed by Pain Intensity Numeric Rating Scale [PI-NRS]	baseline and 4 weeks after injection	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.

Secondary Outcome Measures

Name	Time	Method
Patient Global Impression of Change [PGIC] score	4, 8, 12 weeks
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
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

Trial Locations

Locations (11)

Sanofi-Aventis Investigational Site Number 840017; 🇺🇸 Sacramento, California, United States

Sanofi-Aventis Investigational Site Number 840026; 🇺🇸 New York, New York, United States

Sanofi-Aventis Investigational Site Number 840013; 🇺🇸 Boynton Beach, Florida, United States

Sanofi-Aventis Investigational Site Number 840008; 🇺🇸 Stockton, California, United States

Sanofi-Aventis Investigational Site Number 840028; 🇺🇸 San Diego, California, United States

Sanofi-Aventis Investigational Site Number 840047; 🇺🇸 Clearwater, Florida, United States

Sanofi-Aventis Investigational Site Number 840034; 🇺🇸 Atlanta, Georgia, United States

Sanofi-Aventis Investigational Site Number 840044; 🇺🇸 Fort Worth, Texas, United States

Sanofi-Aventis Investigational Site Number 840023; 🇺🇸 Southlake, Texas, United States

Sanofi-Aventis Investigational Site Number 840001; 🇺🇸 Fresno, California, United States

Sanofi-Aventis Investigational Site Number 840005; 🇺🇸 Beverly Hills, California, United States