Trial protocol
hypoparathyroidism
HYPOPARATHYROIDISM
Once enrolled, participants were randomized 3:1 into two treatment groups: TransCon PTH 18 μg PTH(1‐34)/d or placebo (excipient solution) mimicking 18 μg/d, both co‐administered with conventional therapy (active vitamin D and elemental calcium). Randomization was stratified by etiology of hypoparathyroidism (postsurgical versus nonsurgical). In addition to frequent laboratory visits to measure serum calcium levels, the blinded treatment period included 10 clinic visits over 26 weeks. Once‐daily treatment with TransCon PTH or placebo was delivered by a modified Ypsomed (Burgdorf, Switzerland) UnoPen Fix pen injector using 31‐gauge, 5‐mm pen needles to deliver doses of 6–30 μg/injection in a volume of ≤100 μL to either abdomen or anterior thigh, rotating injection sites. All participants were initially prescribed TransCon PTH 18 μg PTH(1‐34)/d or a corresponding volume of placebo and were individually and progressively titrated to an optimal dose (allowable range 6–60 μg/d) in increments of 3 μg/d. Titration of study drug and conventional therapy was performed according to a protocol‐specified algorithm guided by serum calcium values (Supplemental Fig. 