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Correspondence to Author: Sonathan K Lang, 

Departments of Endocrinology and Clinical Biochemistry, Norfolk and Norwich University Hospital, Norwich, UK.

ABSTRACT: 
It can be difficult for patients and clinicians to manage hypophosphatemia, hyperphosphatemia, and hypercalciuria while treating primary hypoparathyroidism (hypoPT) with oral calcium supplementation and calcitriol (or an analog). Human parathyroid hormone (hPTH) (1-84) injected subcutaneously once a day was approved as an adjuvant treatment in 2015 for patients who did not respond favorably to traditional treatments. The purpose of this open-label trial was to evaluate the safety and effectiveness of an oral hPTH(1-34) formulation in adult individuals with hypoparathyroidism as a supplement to routine care. For 16 weeks straight, oral hPTH(1-34) tablets (0.75 mg human hPTH(1-34) acetate) were given four times a day. Additionally, adjustments were made to the calcium supplementation and use of alfacalcidol, albumin-adjusted serum calcium (ACa), serum phosphate, and albumin-adjusted serum calcium.Throughout the trial, quality of life and urinary calcium excretion were recorded. Fifteen of the nineteen participants that were enrolled finished the trial as directed. A median 42% decrease from baseline in the exogenous calcium dose was seen (p =.001), whereas the median blood ACa levels for hypoPT patients (>7.5 mg/dL) remained higher than the lower goal ACa values over the trial. Serum phosphate median levels dropped sharply (23%, p =.0003) two hours after the initial dose and stayed in the normal range the whole period. Between the first and last treatment days, there was a noticeable, but not statistically significant, median decrease in 24-hour urine calcium excretion (21%, p =.07). There were just four potential, mild side effects linked to the medication recorded during the the same patient participated in a 16-week study. By the end of the treatment period, a slight but statistically significant gain in quality of life (5%, p =.03) was observed from baseline. In adult patients with hypoparathyroidism, oral hPTH(1-34) medication was typically safe, well tolerated, and allowed for a reduction in exogenous calcium supplementation while maintaining normocalcemia. The American Society for Bone and Mineral Research (ASBMR) is represented by Wiley Periodicals LLC, the publisher of the Journal of Bone and Mineral Research.

Citation:

Sonathan K Lang.An open-label study examined the safety and effectiveness of oral human parathyroid hormone (1-34) in hypoparathyroidism. The Journal of Bone and Mineral Research 2024.