Clinical trial NCT01001715: Single Injection of REGN475/SAR164877 in Treatment of Vertebral Fracture Pain
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Back Pain
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2009-10-27
Enrollment: 41
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Mean change from baseline in pain intensity as assessed by Pain Intensity Numeric Rating Scale [PI-NRS]
timeFrame: baseline and 4 weeks after injection
Secondary outcomes:
measure: Mean change from baseline in pain intensity as assessed by PI-NRS
timeFrame: baseline and every other weeks up to 12 weeks after injection
measure: Percentage of pain-free days (score "0" pain on PI-NRS)
timeFrame: 12 weeks
measure: Percentage of days with rescue analgesia use
timeFrame: 12 weeks
measure: Change from baseline in Quality of Life Questionnaire of the European Foundation for Osteoporosis [QUALEFFO] score
timeFrame: baseline and 4, 8, 12 weeks
measure: Change from baseline in Short Form-12 Item Quality of Life Questionnaire [SF-12] score
timeFrame: baseline and 4, 8, 12 weeks
measure: Patient Global Impression of Change [PGIC] score
timeFrame: 4, 8, 12 weeks
measure: Percentage of participants with at least 30% and 50% reduction from baseline in pain intensity
timeFrame: up to 12 weeks after injection
measure: Pharmacokinetic: REGN475/SAR164877 serum concentration
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Sanofi-Aventis Investigational Site Number 840005
state: California
city: Fresno
country: United States
facility: Sanofi-Aventis Investigational Site Number 840001
state: California
city: Sacramento
country: United States
facility: Sanofi-Aventis Investigational Site Number 840017
state: California
city: San Diego
country: United States
facility: Sanofi-Aventis Investigational Site Number 840028
state: California
city: Stockton
country: United States
facility: Sanofi-Aventis Investigational Site Number 840008
state: California
city: Boynton Beach
country: United States
facility: Sanofi-Aventis Investigational Site Number 840013
state: Florida
city: Clearwater
country: United States
facility: Sanofi-Aventis Investigational Site Number 840047
state: Florida
city: Atlanta
country: United States
facility: Sanofi-Aventis Investigational Site Number 840034
state: Georgia
city: New York
country: United States
facility: Sanofi-Aventis Investigational Site Number 840026
state: New York
city: Fort Worth
country: United States
facility: Sanofi-Aventis Investigational Site Number 840044
state: Texas
city: Southlake
country: United States
facility: Sanofi-Aventis Investigational Site Number 840023
state: Texas
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: