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Effects of PTH(1–84) therapy on muscle function and quality of life in hypoparathyroidism: results from a randomized controlled trial

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Abstract

Summary

The effects of treatment with 100 μg parathyroid hormone (PTH) (1–84) or an identical placebo on muscle function and quality of life (QoL) was studied in hypoparathyroid patients. At baseline, we found reduced QoL but no myopathy in the patients. Six months of treatment did not improve QoL, and muscle strength decreased slightly.

Introduction

A reduced quality of life (QoL) and myopathy that may be due to the absence of PTH have been reported in patients with hypoparathyroidism (hypoPT).

Methods

Sixty-two patients with chronic hypoPT were randomized to 6 months of treatment with either PTH(1–84) 100 μg/d s.c. or placebo, given as add-on therapy to conventional treatment. Muscle function and postural stability were investigated using a dynamometer chair, a stadiometer platform, the repeated chair stands test, the timed up and go test, and electromyography. QoL was assessed using the 36-item Short Form Health Survey and the WHO-5 Well-Being Index.

Results

The mean age of the patients was 52 ± 11 years, and 85 % were females. At baseline, QoL was significantly reduced in comparison with norm-based scores. Compared with placebo, PTH did not improve QoL or muscle function. Rather, max force production decreased significantly by 30 % at elbow flexion in the PTH group compared with the placebo group. Moreover, there was a nonsignificant trend for muscle strength to decrease in the upper extremities and on knee extension in response to PTH. Treatment did not affect postural stability. Electromyography showed a slight decrease in the duration of motor unit potentials in the PTH group, indicating a tendency toward myopathy, which, however was not symptomatic.

Conclusions

Overall, our data do not support an immediate beneficial effect of PTH replacement therapy on muscle function or QoL. A high frequency of hypercalcemia among our patients may have compromised the potential beneficial effects of reversing the state of PTH insufficiency.

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Funding

Nycomed supplied study drugs (PTH (1–84) and identical placebo) for free. Financial support was granted by The Danish Council for Independent Research in Medical Science, The Novo Nordic Foundation and the Central Denmark Region Foundation.

Conflicts of interest

Tanja Sikjaer, Lars Rejnmark, Lars Rolighed, Anders Fuglsang-Frederiksen, and Alexander Hess have no conflicts of interests. Leif Mosekilde was a principal investigator in the REPLACE study initiated by NPS Pharmaceuticals in 2009–2011.

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Authors and Affiliations

  1. Osteoporosis Clinic, Department of Internal Medicine and Endocrinology, MEA, Aarhus University Hospital, Tage-Hansensgade 2, 8000, Aarhus, Denmark

    T. Sikjaer, L. Mosekilde & L. Rejnmark

  2. Department of Surgery P, Aarhus University Hospital, Aarhus, Denmark

    L. Rolighed

  3. Department of Clinical Neurophysiology, Aarhus University Hospital, Aarhus, Denmark

    A. Hess & A. Fuglsang-Frederiksen

Authors
  1. T. Sikjaer
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  2. L. Rolighed
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  3. A. Hess
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  4. A. Fuglsang-Frederiksen
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  5. L. Mosekilde
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  6. L. Rejnmark
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Corresponding author

Correspondence to T. Sikjaer.

Additional information

ClinicalTrials.gov no.

NCT00730210

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Sikjaer, T., Rolighed, L., Hess, A. et al. Effects of PTH(1–84) therapy on muscle function and quality of life in hypoparathyroidism: results from a randomized controlled trial. Osteoporos Int 25, 1717–1726 (2014). https://doi.org/10.1007/s00198-014-2677-6

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  • DOI: https://doi.org/10.1007/s00198-014-2677-6

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