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

The Lancet Diabetes & Endocrinology Apr 28, 2020

Leere JS, Karmisholt J, Robaczyk M, et al. - In patients with primary hyperparathyroidism, researchers conducted this randomised, single-centre, proof-of-concept, double-blind trial to evaluate the effectiveness of denosumab and combined with cinacalcet. From the Department of Endocrinology, Aalborg University Hospital, Aalborg, Denmark, patients aged at least 18 years with primary hyperparathyroidism were involved. Participants in the study were assigned (1:1:1) by permuted block randomisation to receive 30 mg cinacalcet per day plus 60 mg denosumab subcutaneously every 6 months (n = 14; combination group) for 1 year, denosumab plus placebo (n = 16; denosumab group) for 1 year, or placebo plus placebo injection (n = 15; placebo group) for 1 year. Two hundred eighty-five participants were recruited between March 14, 2017, and March 16, 2018. Findings suggested that denosumab was effective in improving BMD and lowering bone turnover in patients with primary hyperparathyroidism, regardless of cinacalcet therapy, and may be a valid option for patients in whom surgery is undesirable.

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