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Denosumab for osteoporosis has no impact on aortic calcification or adverse CV events
DOI:10.1038/bonekey.2014.35
The FREEDOM trial demonstrated a 40% reduction in the risk of hip fracture and a 68% fall in the risk of a vertebral fracture in postmenopausal women treated with denosumab. But was denosumab treatment associated with either progression of aortic calcification or with adverse cardiovascular (CV) events in the long-term? Samelson et al. investigated.
Their dataset included 2363 osteoporotic postmenopausal women determined to be at high risk of a CV event; 1221 treated with denosumab and 1142 from the placebo group. Progression in aortic calcification was measured using lateral spine X-rays (this method was semiquantitative).
Both the treated and placebo groups showed identical levels of progression of aortic calcification (22%, p=98) over 3 years. The occurrence of an adverse CV event was not significantly different between the two groups either; 40% in the placebo-treated women and 38% in the denosumab group.
Editor’s comment: Despite biological evidence for a role of osteoprotegerin in preventing vascular calcifications, denosumab failed to prevent progression of aortic calcifications or CV events. These results are important with regard to the safety of denosumab in patients at high CV risk. The possibility of a false negative result exists, however, due to the post-hoc nature of the analysis. As a result, the study is probably underpowered. Additionally, regular X-rays also have low sensitivity for detecting changes in aortic calcifications; CT-scan images might have improved the detection rate.
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