The Food and Drug Administration (FDA) has approved the use of Prolia (denosumab; Amgen) for the treatment of glucocorticoid-induced osteoporosis in men and women at high risk for fracture who are either initiating or continuing system glucocorticoids in a daily dosage equivalent to ≥7.5mg of prednisone and expected to remain on glucocorticoids for at least 6 months.
“Patients on long-term systemic glucocorticoid medications can experience a rapid reduction in bone mineral density within a few months of beginning treatment,” said study lead Kenneth F. Saag, MD, MSc, professor of medicine at the University of Alabama at Birmingham School of Medicine. “With this approval, patients who receive treatment with glucocorticoids now have a new option to help improve their bone mineral density.”
The efficacy and safety of Prolia in the treatment of patients with glucocorticoid-induced osteoporosis was assessed in the 12-month primary analysis of a 2-year, randomized, multicenter, double-blind, parallel-group, active-controlled study (N=795). Patients were randomized to receive an oral daily bisphosphonate (risedronate 5mg once daily) or Prolia 60mg subcutaneously once every 6 months for 1 year.
Results showed that compared to the active-control, treatment with Prolia significantly increased lumbar spine bone mineral density (BMD) at 1 year in the glucocorticoid-initiating subpopulation (4.4% vs 2.3%; treatment difference: 2.2%; P<.001). Moreover, in the glucocorticoid-continuing subpopulation, treatment with Prolia was associated with significant increases in lumbar spine BMD compared with active-control (3.8% vs 0.8%; treatment difference: 2.9%; P<.001). Effects on lumbar spine BMD within each subpopulation were consistent regardless of gender, race, menopausal status, baseline age, lumbar spine BMD T-score, or glucocorticoid dose. The safety profile of Prolia was found to be consistent with previous trials.
Prolia, a human IgG2 monoclonal antibody with affinity and specificity for human RANKL (receptor activator of nuclear factor kappa-B ligand), works by preventing RANKL from activating its receptor, RANK, on the surface of osteoclasts and their precursors. This inhibits osteoclast formation, function, and survival, thereby decreasing bone resorption and increasing bone mass and strength in both cortical and trabecular bone.
In addition to this new indication, Prolia is already approved for: postmenopausal women with osteoporosis at high risk for fracture; men with osteoporosis at high risk for fracture to increase bone mass; men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer to increase bone mass; and women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer to increase bone mass.
Prolia is supplied as 60mg/mL in a single-dose prefilled syringe.
For more information visit Prolia.com.