Brief Results
In Adults with hypoparathyroidism, TransCon PTH (palopegteriparatide) administered once daily compared to Placebo showed At week 52, 81% achieved normal serum calcium and independence from conventional therapy, 95% achieved independence from conventional therapy, mean 24-hour urine calcium decreased from 376 mg/day to 195 mg/day, most adverse events were mild or moderate.
Study Details
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Population Adults with hypoparathyroidism |
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Intervention TransCon PTH (palopegteriparatide) administered once daily |
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Comparison Placebo |
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Outcome At week 52, 81% achieved normal serum calcium and independence from conventional therapy, 95% achieved independence from conventional therapy, mean 24-hour urine calcium decreased from 376 mg/day to 195 mg/day, most adverse events were mild or moderate |
Summary
This Phase 3 trial compared TransCon PTH to placebo in adults with hypoparathyroidism over 52 weeks. The study aimed to assess the efficacy and safety of TransCon PTH. Results showed that TransCon PTH significantly improved serum calcium levels and reduced the need for conventional therapy compared to placebo (p<0.05). Patient-reported outcomes and bone mineral density also improved. The safety profile demonstrated that most adverse events were mild or moderate, with no trial discontinuations due to adverse events.
Publication Details
Authors: Clarke BL, Khan AA, Rubin MR, Schwarz P, Vokes T, Shoback DM, Gagnon C, Palermo A, Abbott LG, Hofbauer LC, Kohlmeier L, Cetani F, Pihl S, An X, Smith AR, Lai B, Ukena J, Sibley CT, Shu AD, Rejnmark L
Journal: The Journal of clinical endocrinology and metabolism
Date: 17 Mar 2025
This PICO summary was generated through the collaborative efforts of Hormone Insight’s artificial intelligence system and underwent expert clinical review to ensure accuracy and relevance.
