NCT01001715: REGN475 for osteoporotic vertebral-fracture pain

This was a randomized, double-blind phase 2 study of one intravenous administration of REGN475/SAR164877 for pain from osteoporotic vertebral fracture. The registry reports 41 actual participants, ages 40–80, with moderate-to-severe pain. Participants received the investigational treatment or placebo and were followed for approximately 12 weeks. 1 2

The principal question was pain reduction; secondary objectives included safety, tolerability, drug exposure, and immune responses against the treatment. The inspected historical record was updated in May 2013 and labels the study terminated. 1 2

I did not verify an effect size, an adverse-event comparison, or the termination reason for this exact protocol. Consequently, neither effectiveness nor treatment-caused harm can be concluded from the termination label. This study also should not be confused with treatment of vertebral instability or with a procedure that repairs the fracture. 1 2

Sources

1. ClinicalTrials.gov — ClinicalTrials.gov — NCT01001715. Original study registration: sponsor, design, population, endpoints and dated history.Original study registration · Original record checked against the registry API. Checked 2026-10-10. Registration and current registry fields do not by themselves establish efficacy. Historical details in the article retain their stated date. Supplied note: ClinicalTrials.gov — NCT01001715. Original study registration: sponsor, design, population, endpoints and dated history.