Endocrinology · 3 h ago
Palopegteriparatide outcomes reported through 3.5 years in hypoparathyroidism
A phase 3 trial and open-label extension followed 82 adults with hypoparathyroidism; 73 completed 182 weeks. At the final assessment, most participants were independent of therapeutic doses of calcium and active vitamin D, and 89% were normocalcemic.
- 73 participants completed 182 weeks of follow-up.
- 96% were independent of therapeutic-dose calcium.
- 89% were normocalcemic at Week 182.
- Open-label extension limits comparative conclusions.
The PaTHway phase 3 trial enrolled 82 adults with hypoparathyroidism at 21 sites in North America and Europe. Participants were randomized to palopegteriparatide or placebo for 26 weeks, followed by a 156-week open-label extension in which all received titrated palopegteriparatide. The study assessed independence from conventional therapy, normocalcemia, renal and skeletal measures, patient-reported outcomes, and safety; 73 participants completed Week 182.
At Week 182, 70 of 73 participants (96%) were independent of therapeutic doses of calcium, all 73 were independent of active vitamin D, and 65 (89%) were normocalcemic. Early normalization of mean 24-hour urine calcium, gains in mean estimated glomerular filtration rate, and improvements in patient-reported outcomes were reported as maintained. Bone turnover markers increased and stabilized above baseline; bone mineral density Z-scores remained above zero while trending toward age- and sex-matched norms. Most adverse events were mild to moderate.
These findings suggest sustained effects over 3.5 years in adults who continued treatment. The extension was open-label and had no ongoing placebo comparison, and 9 of the 82 randomized participants did not complete Week 182. The supplied report does not provide detailed adverse-event rates or subgroup results.
In practice
For adults with hypoparathyroidism treated with palopegteriparatide, this follow-up suggests that reduced reliance on therapeutic-dose calcium and active vitamin D, normocalcemia, and reported renal and patient-reported improvements can persist through 3.5 years. The results add long-term evidence relevant to treatment discussions, but do not establish comparative benefit beyond the initial 26-week randomized period: the extension was open-label, all participants received active treatment, and 73 of 82 randomized participants completed Week 182. The findings alone do not establish a need to change current practice.
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The Journal of Clinical Endocrinology & Metabolism: Palopegteriparatide in Adults With Hypoparathyroidism: 3.5-Year Results From the Phase 3 PaTHway Trial ↗This is an automated AI-condensed summary that has not yet been reviewed by an editor. Always consult the full item at the original source.