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01-04-2017 | Original Article

Safety and efficacy of denosumab in osteoporotic hemodialysed patients

Authors: Francescaromana Festuccia, Maryam Tayefeh Jafari, Alessandra Moioli, Claudia Fofi, Simona Barberi, Stefano Amendola, Salvatore Sciacchitano, Giorgio Punzo, Paolo Menè

Published in: Journal of Nephrology | Issue 2/2017

Abstract

Background and aims

In elderly subjects, renal insufficiency and osteoporosis often coexist with high risk of fracture and elevated socio-economic burden. Today a large number of effective anti-osteoporotic drugs are available but generally they are contraindicated in patients with chronic kidney disease (CKD) because of their progressive accumulation. Denosumab, instead, does not require dose adjustments for different degrees of renal impairment so it can be a valid treatment in osteoporotic patients with CKD. Limited data are available in the literature concerning the use of denosumab in hemodialysis (HD). The aim of our study was, therefore, to study the efficacy and tolerability of this drug in this particular subset of patients.

Methods

We retrospectively reviewed the charts of 12 osteoporotic HD patients who received a single 60-mg subcutaneous dose of denosumab every 6 months for an observation period of 24 months. Serum electrolyte, markers of bone turnover and quantitative ultrasound (QUS) were evaluated.

Results

Over 24 months, we observed a gradual improvement of bone metabolism: β-CrossLaps from 2567.08 ± 1264 to 1492.5 ± 1182.5 pg/ml; bone alkaline phosphatase (BALP) from 33.5 ± 28.8 to 11.8 ± 3.7 mcg/l, and of QUS index (T-score from −5.33 ± 1.58 to −4.84 ± 1.2; risk of fracture from 13.9 ± 4.7 to 11.07 ± 5.3 %). Few cases of hypocalcemia were detected, more significant after the first and second injection, but with careful monitoring of serum calcium and rapid therapy adjustment we could easily manage serum Ca levels.

Conclusions

Our pilot experience highlights the safety and efficacy of denosumab in the treatment of osteoporosis in HD patients, potentially supporting its use to reduce the burden of fractures in this patient population.

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Title: Safety and efficacy of denosumab in osteoporotic hemodialysed patients
Authors: Francescaromana Festuccia
Maryam Tayefeh Jafari
Alessandra Moioli
Claudia Fofi
Simona Barberi
Stefano Amendola
Salvatore Sciacchitano
Giorgio Punzo
Paolo Menè
Publication date: 01-04-2017
Publisher: Springer International Publishing
Published in: Journal of Nephrology / Issue 2/2017
Print ISSN: 1121-8428
Electronic ISSN: 1724-6059
DOI: https://doi.org/10.1007/s40620-016-0334-1

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