Prolia is given by subcutaneous injection into the upper arm, abdomen or thigh every 6 months. Prescribers must ensure patients receive adequate calcium and vitamin D supplementation during treatment.
Denosumab binds to the RANK ligand to prevent activation of the RANK receptor, inhibiting osteoclast formation, function and survival, and thereby decreasing bone resorption.
In a randomised, double-blind, placebo-controlled study in 242 men with low bone mineral density (BMD), denosumab was associated with a significantly greater BMD increase at the lumbar spine (primary endpoint) than placebo after 12 months (5.7% vs 0.9%; p<0.0001). Similar significant differences were also observed in BMD increases in total hip, femoral neck and trochanter (p<0.01 for all).
Prolia may be particularly useful in patients with renal impairment who are unable to receive bisphosphonates, and in patients who were previously taking strontium (Protelos) but were unable to continue following the EMA's restriction on its use owing to cardiovascular safety concerns.
In addition to its osteoporosis indication, Prolia is also licensed for the prevention of fracture in men being treated with hormone ablation therapy in prostate cancer. Denosumab is also available as Xgeva, which is licensed at a higher dose given every 4 weeks for the prevention of skeletal events in patient with bone metastases.
Further information: Amgen