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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01001715
Recruitment Status : Terminated (Business decision due to low subject recruitment and enrollment)
First Posted : October 27, 2009
Last Update Posted : May 27, 2013
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Back Pain Drug: REGN475/SAR164877 Drug: Placebo (for REGN475/SAR164877) Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : November 2009
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01001715

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United States, California
Sanofi-Aventis Investigational Site Number 840005
Beverly Hills, California, United States, 90211
Sanofi-Aventis Investigational Site Number 840001
Fresno, California, United States, 93710
Sanofi-Aventis Investigational Site Number 840017
Sacramento, California, United States, 95817
Sanofi-Aventis Investigational Site Number 840028
San Diego, California, United States, 92103
Sanofi-Aventis Investigational Site Number 840008
Stockton, California, United States, 95204
United States, Florida
Sanofi-Aventis Investigational Site Number 840013
Boynton Beach, Florida, United States, 33472
Sanofi-Aventis Investigational Site Number 840047
Clearwater, Florida, United States, 33755
United States, Georgia
Sanofi-Aventis Investigational Site Number 840034
Atlanta, Georgia, United States, 30328
United States, New York
Sanofi-Aventis Investigational Site Number 840026
New York, New York, United States, 11201
United States, Texas
Sanofi-Aventis Investigational Site Number 840044
Fort Worth, Texas, United States, 76117
Sanofi-Aventis Investigational Site Number 840023
Southlake, Texas, United States, 76092
Sponsors and Collaborators
Regeneron Pharmaceuticals
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Study Director: Clinical Sciences & Operations Sanofi
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Responsible Party: Regeneron Pharmaceuticals Identifier: NCT01001715    
Other Study ID Numbers: ACT11308
First Posted: October 27, 2009    Key Record Dates
Last Update Posted: May 27, 2013
Last Verified: May 2013
Additional relevant MeSH terms:
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Spinal Fractures
Spinal Injuries
Back Injuries
Wounds and Injuries
Fractures, Bone
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs