Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists · 2026
A Novel Method for the Evaluation of Hypercalciuria in Individuals With Chronic Hypoparathyroidism.
Клиническое исследование II фазыСтатьяМногоцентровое исследованиеРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Gosmanova Elvira O, Zhao Carol, Sibley Christopher T, Makara Michael A, Phelps Kenneth R
Аннотация
OBJECTIVES: Guidelines recommend avoiding hypercalciuria during treatment of chronic hypoparathyroidism, but measurements of 24-hour calcium excretion (24-hour urine calcium [24uCa]) have limitations. We evaluated calcium excretion per volume of filtrate (ECa/Ccr), which does not require timed collections, as an alternative to 24uCa to detect hypercalciuria.
METHODS: This was a post-hoc analysis of the PaTH Forward trial (NCT04009291). Fifty-nine adults with chronic hypoparathyroidism managed with conventional therapy were enrolled in a randomized, double-blind, placebo-controlled 4-week period followed by an open-label extension (OLE), in which all participants received palopegteriparatide (TransConPTH). ECa/Ccr was calculated as (Cau×crs)/cru from morning non-fasting samples (Cau-urine calcium, cru-urine creatinine, and crs-serum creatinine). The diagnostic accuracy of ECa/Ccr was assessed using receiver operating characteristic analysis.
RESULTS: Median (interquartile range) 24uCa was 381 (296-602) mg/d at baseline and declined by 61% to 72% during OLE. Mean (SD) ECa/Ccr was 0.249 (0.131) mg/dL at baseline and fell by 47% to 62% during OLE. Area under the curve for ECa/Ccr as a test for hypercalciuria (24uCa >300 mg/d) was 0.837. Hypercalciuria was invariably absent at ECa/Ccr <0.083 mg/dL and almost uniformly present at ECa/Ccr > 0.212 mg/dL. Positive predictive value of ECa/Ccr ≥ 0.149 mg/dL was ≥92% when pretest probability of hypercalciuria was high. Negative predictive value of ECa/Ccr was ≥97% at all cutoffs when pretest probability was low.
CONCLUSIONS: ECa/Ccr correlates with 24uCa in patients with chronic hypoparathyroidism. The lowest ECa/Ccr cutoff values ensure that hypercalciuria is not missed. Sufficiently high ECa/Ccr supports presence of hypercalciuria. In these scenarios, 24uCa collections can be avoided. Intermediate ECa/Ccr must be followed by 24uCa.
METHODS: This was a post-hoc analysis of the PaTH Forward trial (NCT04009291). Fifty-nine adults with chronic hypoparathyroidism managed with conventional therapy were enrolled in a randomized, double-blind, placebo-controlled 4-week period followed by an open-label extension (OLE), in which all participants received palopegteriparatide (TransConPTH). ECa/Ccr was calculated as (Cau×crs)/cru from morning non-fasting samples (Cau-urine calcium, cru-urine creatinine, and crs-serum creatinine). The diagnostic accuracy of ECa/Ccr was assessed using receiver operating characteristic analysis.
RESULTS: Median (interquartile range) 24uCa was 381 (296-602) mg/d at baseline and declined by 61% to 72% during OLE. Mean (SD) ECa/Ccr was 0.249 (0.131) mg/dL at baseline and fell by 47% to 62% during OLE. Area under the curve for ECa/Ccr as a test for hypercalciuria (24uCa >300 mg/d) was 0.837. Hypercalciuria was invariably absent at ECa/Ccr <0.083 mg/dL and almost uniformly present at ECa/Ccr > 0.212 mg/dL. Positive predictive value of ECa/Ccr ≥ 0.149 mg/dL was ≥92% when pretest probability of hypercalciuria was high. Negative predictive value of ECa/Ccr was ≥97% at all cutoffs when pretest probability was low.
CONCLUSIONS: ECa/Ccr correlates with 24uCa in patients with chronic hypoparathyroidism. The lowest ECa/Ccr cutoff values ensure that hypercalciuria is not missed. Sufficiently high ECa/Ccr supports presence of hypercalciuria. In these scenarios, 24uCa collections can be avoided. Intermediate ECa/Ccr must be followed by 24uCa.