Treatment of Hypoparathyroidism With Subcutaneous PTH (1-84) Injections: Effects on Muscle Function and Quality of Life
Condition: Hypoparathyroidism
MeSH terms: Hypoparathyroidism
Study type: Interventional
Phase: Phase 2

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 description: 
      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 treatment are
           assessed by measurements of calcitropic hormones, biochemical markers of bone turnover,
           and iliac crest biopsies. In addition, bone mineral density and body composition is
           measured.
    

Intervention name(s): a: PTH (1-84); b:placebo
Intervention type(s): Drug; Drug
Intervention description(s): preotact 100 microgram subcutaneous a day in 6 months; 100 microgram placebo subcutaneous a day for 6 months
Other intervention name(s): preotact; Placebo
Intervention MeSH terms: Parathyroid Hormone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hypoparathyroidism; HypoPTH; PTH