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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Back Pain

Intervention / Treatment
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* Drug: REGN475/SAR164877
* Drug: Placebo (for REGN475/SAR164877)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 | Measure Description | 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 |