Amgen announces positive results in Phase III trial of Prolia

Amgen this week announced positive results in its Phase III study evaluating Prolia (denosumab) in comparison to risedronate in patients receiving glucocorticoid treatment.

"The impact of glucocorticoid therapy on bone strength is frequently underestimated, and often leads to increased bone loss and ultimately, a fracture," Amgen EVP of Research and Development Dr. Sean E. Harper said. "We are excited that these data support the potential for Prolia use in patients with glucocorticoid-induced osteoporosis, the most common drug-induced form of the disease."

The trial enrolled 795 patients, with 505 who had been receiving ongoing glucocorticoid therapy and 290 who started therapy in the previous three months. The patients were randomized into two groups. One group received Prolia and the other received risedronate.

When the patients' bone mineral density (BMD) was measured at 12 months, the Prolia patients showed a greater increase in BMD than the risedronate patients. The study is continuing for another 12 months.

Glucocorticoid-induced osteoporosis (GIOP) is caused by glucocorticoid medications, such as prednisone, which cause bone loss. A patient's risk of breaking a bone, such as a hip, increases up to 75 percent within the first three months of beginning glucocorticoid treatment.