Phase III data for Prolia in Osteoporosis-Amgen

Amgen has announced results from a new exploratory analysis of the open-label extension study of the pivotal Phase III fracture trial, which found that treatment with Prolia (denosumab) for eight years enabled a substantial proportion of women with Osteoporosis to achieve non-osteoporotic T-scores at the lumbar spine and total hip from baseline. The percentage of women with non-osteoporotic T-scores (>-2.5, >-2.2, >-2.0, and >-1.8) at both the lumbar spine and total hip progressively increased from baseline over eight years of Prolia treatments as follows: 11 to 82 percent (>=2.5), 4 to 65 percent (>=2.2), 2 to 53 percent (>=2.0), and 1 to 39 percent (>=1.8). At individual sites, the percentage of women with a T-score >�2.5 increased from 19 to 86 percent (lumbar spine) and from 75 to 94 percent (total hip).

In the Freedom Extension crossover group, analysis showed that in the placebo group, cortical bone density at the radius declined despite calcium and vitamin D supplementation. Prolia treatment for three years reversed this bone loss and an additional two years resulted in further bone mineral density (BMD) gains that reduced wrist fracture rates. With five years of Prolia treatment, a significant gain in BMD (1.5 percent) was observed, compared with EXT baseline. Finally, persistence and compliance over 12 months was higher among patients who had newly initiated Prolia compared with other Osteoporosis therapies. Data were presented at the American Society for Bone and Mineral Research (ASBMR) 2014 Annual Meeting.