Radius Health Study Meets Main Goal In Incident Vertebral Fracture Patients

(RTTNews) - Radius Health, Inc. (RDUS) reported positive top-line 18-month fracture results from the company's Phase 3 clinical trial, dubbed ACTIVE, evaluating the investigational drug abaloparatide-SC for potential use in the reduction of fractures in postmenopausal osteoporosis.

On the primary endpoint, abaloparatide-SC achieved a statistically significant 83 percent reduction of incident vertebral fractures as compared to the placebo-treated group. The ACTIVE trial included an open-label teriparatide injection treatment group that showed a 78 percent reduction of incident vertebral fractures as compared to the placebo-treated group.

On the secondary endpoints as compared to placebo, abaloparatide-SC achieved a statistically significant fracture-rate reduction of 43 percent in the adjudicated non-vertebral fracture subset of patients.

It also achieved a statistically significant reduction of 41 percent in the adjudicated clinical fracture group, which includes both vertebral and non-vertebral fractures; and a statistically significant difference in the time to first incident non-vertebral fracture in the adjudicated non-vertebral fracture as well as the clinical fracture subset of patients.

The most frequently reported adverse events were back pain, arthralgia, upper respiratory infection, hypercalciuria and dizziness.