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Business decision due to low subject recruitment and enrollment
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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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| REGN475/SAR164877 | Experimental | REGN475/SAR164877, single injection, dose depending on the participant's body weight |
|
| Placebo | Placebo Comparator | Placebo (for REGN475/SAR164877), single injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REGN475/SAR164877 | Drug | Pharmaceutical form: solution Route of administration: intravenous infusion over 30 minutes |
|
| 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 |
| 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 |
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Inclusion criteria:
- Moderate to severe pain due to non-traumatic vertebral fracture associated with osteoporosis.
Exclusion criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanofi-Aventis Investigational Site Number 840005 | Beverly Hills | California | 90211 | United States | ||
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| Placebo (for REGN475/SAR164877) | Drug | Pharmaceutical form: solution Route of administration: intravenous infusion over 30 minutes |
|
| 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 |
| Sanofi-Aventis Investigational Site Number 840001 |
| Fresno |
| California |
| 93710 |
| United States |
| Sanofi-Aventis Investigational Site Number 840017 | Sacramento | California | 95817 | United States |
| Sanofi-Aventis Investigational Site Number 840028 | San Diego | California | 92103 | United States |
| Sanofi-Aventis Investigational Site Number 840008 | Stockton | California | 95204 | United States |
| Sanofi-Aventis Investigational Site Number 840013 | Boynton Beach | Florida | 33472 | United States |
| Sanofi-Aventis Investigational Site Number 840047 | Clearwater | Florida | 33755 | United States |
| Sanofi-Aventis Investigational Site Number 840034 | Atlanta | Georgia | 30328 | United States |
| Sanofi-Aventis Investigational Site Number 840026 | New York | New York | 11201 | United States |
| Sanofi-Aventis Investigational Site Number 840044 | Fort Worth | Texas | 76117 | United States |
| Sanofi-Aventis Investigational Site Number 840023 | Southlake | Texas | 76092 | United States |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000626997 | fasinumab |
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