Hypoparathyroidism Clinical Trial
Official title:
Treatment of Hypoparathyroidism With Subcutaneous PTH (1-84) Injections: Effects on Muscle Function and Quality of Life
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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