In this one-year, non-pivotal study, denosumab treatment achieved significantly greater bone mineral density (BMD) gains at the total hip, hip trochanter and distal radius compared with alendronate (Fosamax). For the primary endpoint, the relative magnitude of BMD improvement at the total hip was approximately 40% greater in the denosumab versus the alendronate group. The changes in BMD in the alendronate group were consistent with previously reported studies.
The incidence and types of adverse events observed in this study were similar between the denosumab and alendronate treatment groups. The most common adverse events across both treatment arms were arthralgia, back pain, constipation and dyspepsia.