Back Pain
Conditions
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.
Interventions
Pharmaceutical form: solution Route of administration: intravenous infusion over 30 minutes
Pharmaceutical form: solution Route of administration: intravenous infusion over 30 minutes
Sponsors
Regeneron Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
| Mean change from baseline in pain intensity as assessed by PI-NRS | baseline and every other weeks up to 12 weeks after injection |
| 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 |
| Change from baseline in Short Form-12 Item Quality of Life Questionnaire [SF-12] score | baseline and 4, 8, 12 weeks |
Countries
United States
Outcome results
None listed