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Safety and efficacy of denosumab in osteoporotic hemodialysed patients

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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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Author information

Authors and Affiliations

  1. Nephrology and Dialysis Unit, Department of Clinical and Molecular Medicine, Sapienza University of Rome, Sant’Andrea Hospital, Rome, Italy

    Francescaromana Festuccia, Maryam Tayefeh Jafari, Alessandra Moioli, Claudia Fofi, Simona Barberi, Giorgio Punzo & Paolo Menè

  2. Section of Endocrinology and Diabetology, Ospedale Israelitico, Rome, Italy

    Stefano Amendola

  3. Department of Clinical and Molecular Medicine, Sapienza University of Rome, Policlinico Umberto I, Rome, Italy

    Salvatore Sciacchitano

  4. Laboratory of Biomedical Research, Niccolò Cusano University Foundation, Rome, Italy

    Salvatore Sciacchitano

  5. Division of Nephrology, Sant’Andrea University Hospital, Via di Grottarossa 1035-1039, 00189, Rome, Italy

    Francescaromana Festuccia, Alessandra Moioli, Claudia Fofi, Simona Barberi, Giorgio Punzo & Paolo Menè

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  1. Francescaromana Festuccia
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  2. Maryam Tayefeh Jafari
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Correspondence to Francescaromana Festuccia or Alessandra Moioli.

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Conflict of interest

None of the authors has a conflict of interest. No financial support was requested to conduct this study.

Ethical approval

This article does not contain any studies with animals participants performed by any of the authors.

Ethical standards

All procedures performed in studies involving the human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. The manuscripts has not been submitted to more than one journal for simultaneous consideration. The manuscript has not been published previously (partly or in full). The study is not split up into several parts to increase the quantity of submission and submitted to various journals or to one journal over time. No data, text or theories by others are presented as if they were the author’s own. Study documentation was approved by an Institutional Review Board/Independent Ethics Committee. Informed consent was obtained from all participants.

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Festuccia, F., Jafari, M.T., Moioli, A. et al. Safety and efficacy of denosumab in osteoporotic hemodialysed patients. J Nephrol 30, 271–279 (2017). https://doi.org/10.1007/s40620-016-0334-1

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  • DOI: https://doi.org/10.1007/s40620-016-0334-1

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