"I think that’s informative about what the long-term trend might be," he commented.
The safety analysis included 2,343 women on the RANK ligand for the full 5 years and 2,207 crossed over to open-label denosumab after 3 years on placebo.
An increased risk of endocarditis is also mentioned in the prescribing information based on three cases that occurred in the first 3 years; however, no further cases have occurred during the extension phase. Moreover, upon closer inspection one of the three cases of endocarditis appears suspect, as it didn’t result in hospitalization or antibiotic therapy.
Malignancy rates have remained similar and stable over time in both study arms, with no evidence of a concentration of cases in any organ system, according to Dr. Bone.
Dr. McClung and Dr. Bone disclosed that they serve as consultants to and are on the speakers bureau of Amgen, which sponsored the clinical trials. Dr. Cummings is also a consultant to the company.