ABSTRACT
headaches, mild/moderate, hypoparathyroidism, PaTHway, hypocalcemia
HYPOCALCEMIA, SECONDARY, HYPOPARATHYROIDISM, ADVERSE EVENTS
Conventional therapy for hypoparathyroidism consisting of active vitamin D and calcium aims to alleviate hypocalcemia but fails to restore normal parathyroid hormone (PTH) physiology. PTH replacement therapy is the ideal physiologic treatment for hypoparathyroidism. The double‐blind, placebo‐controlled, 26‐week, phase 3 PaTHway trial assessed the efficacy and safety of PTH replacement therapy for hypoparathyroidism individuals with the investigational drug TransCon PTH (palopegteriparatide). Participants (TransCon PTH is an investigational once‐daily prodrug providing sustained release of active PTH designed to maintain stable PTH levels in the physiological range for 24 hours/day. The PaTHway trial met all primary and key secondary endpoints with statistically significant differences from placebo. Most adverse events (AEs) were mild/moderate. Injection‐site reactions and headaches were the most common treatment‐related AEs.