Impact of chronic hypoparathyroidism on health-related quality of life, symptoms, employment, and relationships: findings from a 13-country patient survey

Bollerslev, Jens; Bent‐Ennakhil, Nawal; Chen, Kristina; Clarke, B.L.; Dahl-Hansen, Helen; Germak, John; Gibson, Katie; Glenister, Elizabeth; Judge, Davneet; Marelli, Claudio; Siggelkow, Heide

doi:10.1530/endoabs.63.gp25

Cited by 1 publication

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“…Although some decreases in the average alfacalcidol doses were observed throughout the study, mean alfacalcidol doses reduced 4.3% from 1.1 to 1.0 μg per day, which was not significantly different from baseline doses. Despite significant reductions in supplemental calcium doses, total serum ACa levels remained stable and above the lower target ACa levels for hypoPT patients (>7.5 mg/ dL (10) ) ( Fig. 1B).…”

Section: Reduction In Supplemental Calcium and Alfacalcidol (Or Calcimentioning

confidence: 94%

“…This instrument has been used to assess quality of life in patients with hypoPT. (10) Hypocalcemia-related symptoms were reported at each treatment visit, beginning with the first visit after treatment was initiated.…”

Section: Methodsmentioning

confidence: 99%

“…(9) Patients have repeatedly reported quality of life problems such as altered mood and cognition, which may be caused by the relatively low blood calcium provided by standard treatment. (10)(11)(12) Replacement therapy with PTH has the potential advantages of reducing the high dose of calcium supplements, providing better correction of hypocalcemia and hyperphosphatemia and decreasing urine calcium. With these potential advantages, treatment of PTH deficiency with PTH is compelling.…”

Section: Introductionmentioning

confidence: 99%

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Safety and Efficacy of Oral Human Parathyroid Hormone (1-34) in Hypoparathyroidism: An Open-Label Study

Ish‐Shalom

Caraco

Khazen

et al. 2020

Journal of Bone and Mineral Research

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The standard treatment of primary hypoparathyroidism (hypoPT) with oral calcium supplementation and calcitriol (or an analog), intended to control hypocalcemia and hyperphosphatemia and avoid hypercalciuria, remains challenging for both patients and clinicians. In 2015, human parathyroid hormone (hPTH) (1-84) administered as a daily subcutaneous injection was approved as an adjunctive treatment in patients who cannot be well controlled on the standard treatments alone. This open-label study aimed to assess the safety and efficacy of an oral hPTH(1-34) formulation as an adjunct to standard treatment in adult subjects with hypoparathyroidism. Oral hPTH(1-34) tablets (0.75 mg human hPTH(1-34) acetate) were administered four times daily for 16 consecutive weeks, and changes in calcium supplementation and alfacalcidol use, albumin-adjusted serum calcium (ACa), serum phosphate, urinary calcium excretion, and quality of life throughout the study were monitored. Of the 19 enrolled subjects, 15 completed the trial per protocol. A median 42% reduction from baseline in exogenous calcium dose was recorded (p = .001), whereas median serum ACa levels remained above the lower target ACa levels for hypoPT patients (>7.5 mg/dL) throughout the study. Median serum phosphate levels rapidly decreased (23%, p = .0003) 2 hours after the first dose and were maintained within the normal range for the duration of the study. A notable, but not statistically significant, median decrease (21%, p = .07) in 24-hour urine calcium excretion was observed between the first and last treatment days. Only four possible drug-related, non-serious adverse events were reported over the 16-week study, all by the same patient. A small but statistically significant increase from baseline quality of life (5%, p = .03) was reported by the end of the treatment period. Oral hPTH(1-34) treatment was generally safe and well tolerated and allowed for a reduction in exogenous calcium supplementation, while maintaining normocalcemia in adult patients with hypoparathyroidism.

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Section: Reduction In Supplemental Calcium and Alfacalcidol (Or Calcimentioning

confidence: 94%

Section: Methodsmentioning

confidence: 99%