Clinical Trial: Treatment of Hypoparathyroidism With Subcutaneous PTH (1-84) Injections: Effects on Muscle Function and Quality of Life

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Treatment of Hypoparathyroidism With Subcutaneous PTH (1-84) Injections: Effects on Muscle Function and Quality of Life

Brief Summary: The aim of the study is to assess whether PTH (1-84) therapy posses advantages compared to conventional treatment in patients with hypoparathyroidism on muscle function, quality of life, calcium homeostasis, bone metabolism, and body composition.

Detailed Summary:

Hypoparathyroidism is one of the only hormonal insufficiency states that is usually not treated by replacing the missing hormone. Currently, Standard therapy includes treatment with calcium and an 1alpha-hydroxylated forms of vitamin D (e.g. calcitriol or alphacalcidol) in order to relieve the symptoms associated with hypocalcaemia. However, recent studies have shown that calcium homeostasis can be well regulated by PTH replacement therapy in patients with hypoparathyroidism. It seems that PTH treatment is safe and that it even may posses advantages compared to conventional treatment with vitamin D. As the renal calcium excretion is decreased by PTH therapy, the risk of renal calcifications causing an impaired renal function may be reduced. In addition, some of the hypoparathyroid patients treated with PTH reported less fatigue and increased endurance in response to treatment. This may be due to either a better regulated (i.e. more physiological) calcium homeostasis during PTH therapy, or due to a direct effect of PTH on the neuromuscular system. Therefore, further studies are needed on the effects of PTH replacement in patients with hypoparathyroidism.

Outcome measures:

  • Muscle- and balance function: Effects of treatment on muscle strength and balance function are determined using a dynamometer and a stadiometer (Meititur Ltd, Finland). In addition, effects of treatment on muscle function are assessed through muscle biopsies, electromyographic, echocardiography, and by biochemical measures (muscle enzymes).
  • Quality of life: Effect of treatment on indices of quality of life is assessed using the SF-36v2- and the WHO-Five Well-Being Index (WHO-5)-survey.
  • Calcium homeostasis, bone metabolism, and body composition. Effects of
    Sponsor: University of Aarhus

    Current Primary Outcome: Increase in maximal voluntary knee extension [ Time Frame: 6 months ]

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • Balance function: Is assessed using a stadiometer (Meititur Ltd, Finland) [ Time Frame: 6 months ]
    • Effect of treatment on indices of quality of life is assessed using the SF-36v2- and WHO-Five Well-Being Index (WHO-5)-survey. [ Time Frame: 6 months ]
    • Effects of treatment on muscle function are assessed through muscle biopsies, electromyographic, and by biochemical measures (muscle enzymes). [ Time Frame: 6 months ]
    • Bone mineral density and body composition is measured [ Time Frame: 6 months ]
    • Calcium homeostasis and bone metabolism. Effects of treatment are assessed by measurements of calcitropic hormones, biochemical markers of bone turnover, and bone biopsies [ Time Frame: 6 months ]
    • Q CT scan of hip and spine [ Time Frame: 6 months ]
    • Effects of treatment on diurnal variations of measured biochemical indices, as assessed at the end of the treatment period [ Time Frame: 24 hours at the end of the 6 month treatment period ]
    • Effects of treatment on indices of cardiovascular health (ECG and blood pressure), as measured at the end of the treatment period just prior to and 1 hour after injection of study medication. [ Time Frame: at the end of the 6 months treatment period ]


    Original Secondary Outcome:

    • Balance function: Is assessed using a stadiometer (Meititur Ltd, Finland) [ Time Frame: 6 months ]
    • Effect of treatment on indices of quality of life is assessed using the SF-36v2- and WHO-Five Well-Being Index (WHO-5)-survey. [ Time Frame: 6 months ]
    • Effects of treatment on muscle function are assessed through muscle biopsies, electromyographic, and by biochemical measures (muscle enzymes). [ Time Frame: 6 months ]
    • Bone mineral density and body composition is measured [ Time Frame: 6 months ]
    • Calcium homeostasis and bone metabolism. Effects of treatment are assessed by measurements of calcitropic hormones, biochemical markers of bone turnover, and bone biopsies [ Time Frame: 6 months ]


    Information By: University of Aarhus

    Dates:
    Date Received: August 4, 2008
    Date Started: June 2008
    Date Completion:
    Last Updated: October 23, 2012
    Last Verified: October 2012