The study demonstrated superior results for the primary and all secondary endpoints. For the primary endpoint, the relative magnitude of bone mineral density (BMD) improvement at the total hip was approximately 80% greater in the denosumab compared to the alendronate group.
In this one-year, non-pivotal Phase III study, the group treated with twice -yearly subcutaneous injections of denosumab achieved significantly greater BMD gains at all sites measured including the total hip (primary endpoint), lumbar spine, femoral neck, distal radius, and hip trochanter compared with the group that continued on alendronate.
The incidence and types of adverse events observed in this study, including neoplasm and infection, were well-balanced between the denosumab and alendronate treatment groups. The most common adverse events across both treatment arms were back pain, arthralgia, and nasal pharyngitis.