Recombinant Human rhPTH(1-34) VS Association Alfacalcidol/Hydrochlorothiazide in Severe Primary Hypoparathyroidism
Status:
Completed
Trial end date:
2020-05-28
Target enrollment:
Participant gender:
Summary
Hypoparathyroidism is a rare condition in which the parathyroid glands fail to produce
sufficient amount of parathyroid hormone or the parathyroid hormone produced lacks biologic
activity. The most common cause of hypoparathyroidism is damage to or removal of the
parathyroid glands due to neck surgery for another condition. Occurrence of hypercalciuria
under treatment is a frequent concern in primary hypoparathyroidism, limiting correction of
hypocalcemia.
Hypoparathyroidism can also be caused by an autoimmune process. In rare cases,
hypoparathyroidism may occur as a genetic disorder inherited as an autosomal recessive,
autosomal dominant or X-linked recessive trait. The autosomal dominant hypocalcemia (ADH) is
mainly caused by heterozygous activating mutations in the CASR gene encoding CaSR). As other
severe presentation of primary hypothyroidism, ADH is characterized by the increased risk to
develop hypercalciuria and nephrolithiasis. The purpose of the study is to compare two
therapeutic approaches in severe hypoparathyroidism in order to limit the risk of
nephrocalcinosis and renal failure when attempting to correct hypocalcemia: rhPTH(1-34) vs
association of active vitamin D and hydrochlorothiazide. The European Society of
Endocrinology Clinical has indeed recently published guidelines for the treatment of chronic
hypoparathyroidism in adults. These guidelines suggest considering treatment with a thiazide
diuretic In a patient with hypercalciuria and replacement therapy with PTH in patients who do
not stably and safely maintain their serum and urinary calcium in the target range.