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Denosumab found safe in long-term extension trial
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Denosumab in the treatment of patients with osteoporosis did not show any increase in common adverse events in a long-term trial, according to recently published data.
“All of this is consistent with an excellent safety and tolerability profile for denosumab treatment for osteoporosis,” Nelson B. Watts, MD, at Mercy Health in Cincinnati, said in a press release.
Watts and colleagues assessed the incidences of back pain, pain in extremity, musculoskeletal pain, hypercholesterolemia and cystitis, as well as other adverse events in women who initially received placebo during the FREEDOM trial and then received 60 mg of subcutaneous denosumab for up to 6 years.
The FREEDOM trial denosumab (n = 2,343) compared with long-term denosumab (n = 2,343) showed no increase in back pain (35.8% vs. 14%, respectively), pain in extremity (11.4% vs. 7.1%, respectively), musculoskeletal pain (7.8% vs. 5.3%, respectively), hypercholesterolemia (8.5% vs. 5.6%, respectively), cystitis (6.4% vs. 5.6%, respectively), eczema (3.24% vs. 2.77%, respectively) and endocarditis (0.04% vs. 0%, respectively). However, there was an increase in malignancy (2.35% vs. 5.12%, respectively), pancreatitis (0.04% vs. 0.21%, respectively) and infections (3.07% vs. 3.5%, respectively).
“Age-related events, such as malignancy, would be expected to increase with longitudinal follow-up as the population grows older, the researchers wrote. “Our assessment is that this analysis provides reassuring information regarding safety and tolerability of both short-term and longer-term treatment with denosumab.” – by Will Offit
Disclosures: The researchers report funding by Amgen Inc. Please see the full study for a list of all other relevant financial disclosures.
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