Denosumab and cinacalcet for primary hyperparathyroidism (DENOCINA): a randomised, double-blind, placebo-controlled, phase 3 trial

In proof-of-concept study (n=45), denosumab increased BMD and decreased bone turnover at sites rich in trabecular as well as cortical bone. Co-administration of cinacalcet lowered mean calcium levels to normal range but did not appear to affect development in BMD significantly.

SPS commentary:

According to a commentary, this research fills a gap in an underinvestigated area, i.e. skeleton protection in patients with primary hyperparathyroidism who are ineligible or unwilling to have surgery. It suggests that future prospective studies should better define patients enrolled in terms of skeletal involvement; it could also be desirable to have fractures, instead of BMD, as a primary endpoint and it would be of interest to know if the reported increase of BMD translates to increased fracture resistance, especially in those patients most compromised. It notes that two other points emphasised by the authors might limit adoption of such combination therapy in real-world clinical practice: the cost of the drug (denosumab) and the well-known reversibility of the denosumab effect when discontinued.


The Lancet Diabetes & Endocrinology

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