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FDA approves denosumab for glucocorticoid-induced osteoporosis
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The FDA expanded the indication for the monoclonal antibody denosumab to include the treatment of glucocorticoid-induced osteoporosis in men and women at high risk for fracture, according to a press release from Amgen.
The approval is based on data from a phase 3 study that demonstrated adults receiving glucocorticoid therapy who received subcutaneous denosumab (Prolia, Amgen) experienced greater gains in bone mineral density (BMD) vs. those who received oral risedronate therapy.
“As a leader in bone health with more than 20 years of osteoporosis research experience, we are pleased that Prolia will now be available for patients at high risk for fracture who are suffering from bone loss due to long-term glucocorticoid treatment,” Sean E. Harper, MD, executive vice president of research and development at Amgen, said in the release. “This is a serious condition that leads to rapid decreases in bone mineral density and increased risk for fracture. This approval gives patients and physicians a new treatment option.”
As reported previously in Endocrine Today, adults with a history of glucocorticoid-induced osteoporosis assigned to denosumab therapy experienced a greater increase in BMD at the lumber spine and total hip at 12 months vs. similar patients assigned the bisphosphonate risedronate, according to findings from a global, randomized, active-controlled trial published in The Lancet Diabetes & Endocrinology.
Researchers found that denosumab was noninferior to risedronate for the primary outcome in glucocorticoid-continuing participants (4.4% vs. 2.3%) and in glucocorticoid-initiating participants (3.8% vs. 0.8%). Denosumab was superior to risedronate for both secondary and exploratory BMD endpoints at 12 months, according to the researchers.
“Glucocorticoid-induced osteoporosis is a very common cause of metabolic bone disease, perhaps the second most common cause for osteoporosis beyond menopause and aging,” Kenneth G. Saag, MD, professor in the division of clinical immunology and rheumatology at the University of Alabama, told Endocrine Today in an April interview. “We need more ways to manage it. There are a great number of patients that aren’t getting tested or treated for osteoporosis, and now there is promising evidence from a study comparing denosumab with risedronate that it is efficacious, and, in fact, it looks to be more efficacious than risedronate in terms of increasing BMD at the typical sites that we assess.”
During the study, there were no serious adverse events reported in more than 2% of patients in either group. There were no positively adjudicated cases of osteonecrosis of the jaw in either study arm, according to the researchers. – by Regina Schaffer