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Once-weekly teriparatide in hemodialysis patients with hypoparathyroidism and low bone mass: a prospective study

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Abstract

Summary

Once-weekly 56.5-μg teriparatide treatment was significantly associated with the increase in lumbar spine bone mineral density at 48 weeks among hemodialysis patients with hypoparathyroidism and low bone mass; however, discontinuation of treatment because of adverse events was frequently observed. Careful monitoring for adverse events should be required.

Introduction

Once-weekly 56.5-μg teriparatide is reportedly effective for treating osteoporotic patients without renal insufficiency. However, little is known about the efficacy and safety of once-weekly teriparatide in hemodialysis patients.

Methods

We conducted a 48-week prospective, observational cohort study including 22 hemodialysis patients aged 20 years or older with hypoparathyroidism and low bone mass who received once-weekly teriparatide at 56.5 μg at a tertiary care hospital between January 2013 and January 2015. Primary outcomes were within-subject percent changes of bone mineral density (BMD) at the lumbar spine, femoral neck, and distal one-third radius at 24 and 48 weeks. Secondary outcomes included percent changes of serum bone turnover markers (osteocalcin, bone-specific alkaline phosphatase (BAP), N-terminal propeptide of procollagen type 1 (P1NP), and tartrate-resistant acid phosphatase 5b (TRAP-5b)). Adverse events were evaluated.

Results

The BMD increased at the lumbar spine by 3.3 ± 1.9 % (mean ± SEM) and 3.0 ± 1.8 % at 24 and 48 weeks but not in the femoral neck and distal one-third radius. Serum osteocalcin, BAP, and P1NP increased significantly at 4 weeks, maintaining higher concentrations up to 48 weeks, although TRAP-5b decreased gradually during treatment. The baseline BAP was significantly associated with the 48-week percent change in lumbar spine BMD. Transient hypotension was the most common adverse event. Ten patients discontinued treatment because of adverse events.

Conclusions

Once-weekly teriparatide was associated with increased lumbar spine BMD in hemodialysis patients with hypoparathyroidism and low bone mass. Careful monitoring should be required for treatment of such patients.

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Acknowledgments

This study was partially funded by the Okinaka Memorial Institute for Medical Research.

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Authors and Affiliations

  1. Nephrology Center, Toranomon Hospital Kajigaya, 1-3-1, Kajigaya, Takatsu-ku, Kawasaki, Kanagawa, 213-8587, Japan

    K. Sumida, Y. Ubara, J. Hoshino, K. Mise, N. Hayami, T. Suwabe & K. Takaichi

  2. Nephrology Center, Toranomon Hospital, Tokyo, Japan

    K. Sumida, Y. Ubara, J. Hoshino, N. Hayami, T. Suwabe, M. Kawada, A. Imafuku, R. Hiramatsu, E. Hasegawa, M. Yamanouchi, N. Sawa & K. Takaichi

  3. Okinaka Memorial Institute for Medical Research, Tokyo, Japan

    K. Sumida, Y. Ubara & K. Takaichi

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  1. K. Sumida
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  2. Y. Ubara
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Corresponding author

Correspondence to K. Sumida.

Ethics declarations

This study was reviewed and approved by the ethics committee of Toranomon Hospital and registered in the University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR ID: UMIN000009907). All patients provided informed consent.

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Trial registration: UMIN000009907

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Sumida, K., Ubara, Y., Hoshino, J. et al. Once-weekly teriparatide in hemodialysis patients with hypoparathyroidism and low bone mass: a prospective study. Osteoporos Int 27, 1441–1450 (2016). https://doi.org/10.1007/s00198-015-3377-6

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  • DOI: https://doi.org/10.1007/s00198-015-3377-6

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