Denosumab treatment for 12 months compared with risedronate increased bone mineral density at the lumbar spine and total hip in patients continuing glucocorticoid therapy and in patients newly initiating glucocorticoid therapy, according to a press release from Amgen.
The results were obtained from a phase 3 randomized, double blind, double dummy, active-controlled trial to determine the safety and efficacy of denosumab (Prolia, Amgen) compared with risedronate in patients receiving glucocorticoid treatment. At 12 months, all primary and secondary endpoints were met, according to the release.
“The impact of glucocorticoid therapy on bone strength is frequently underestimated, and often leads to increased bone loss and ultimately, a fracture,” Sean E. Harper, MD, executive vice president of Research and Development at Amgen, said in the release. “We are excited that these data support the potential of Prolia use in patients with glucocorticoid-induced osteoporosis, the most common drug-induced form of the disease.”
In the 24-month study, 795 patients were enrolled and were randomly assigned to Prolia 60 mg subcutaneously every 6 months compared with risedronate 5 mg daily; patients were divided into two groups, those receiving continuing glucocorticoid therapy (n = 505) or those newly initiating glucocorticoid therapy (n = 290).
Compared with risedronate, Prolia resulted in greater increases in BMD at the lumbar spine and total hip. In patients newly initiating glucocorticoid therapy, Prolia also led to greater increased in BMD at the lumbar spine and total hip compared with risedronate.
Both treatment groups had similar adverse and serious adverse events.
The study is continuing for another 12 months and results are ongoing.