Prolia Efficacy Data

ARR=absolute risk reduction; BMD=bone mineral density; FRR=fracture risk reduction; RRR=relative risk reduction
* Annualized yearly subject incidence.
† A randomized, double-blind, placebo-controlled study evaluating fracture reduction in postmenopausal patients with osteoporosis receiving 60 mg Prolia (n=3,902) or placebo (n=3,906) subcutaneously once every 6 months for 3 years. Subjects were between the ages of 60 and 90 years and had bone mineral density T-scores < -2.5 and ≥ -4.0. All women received at least 1000 mg calcium and at least 400 IU vitamin D supplementation per day. The primary endpoint was incidence of new vertebral fractures during the entire 36-month treatment period. Times to first hip and nonvertebral fracture were secondary endpoints. The percentages of nonvertebral, hip and new clinical vertebral fractures were cumulative Kaplan-Meier estimates for 3,902 subjects in the Prolia group and 3,906 in the placebo group. In the long-term, open-label extension study, women received Prolia for up to 10 years.¹
‡ In women who received Prolia in the 3-year placebo-controlled phase and continued on therapy in the open-label extension of the FREEDOM study.¹