Observational Study Measuring Palopegteriparatide Levels in Breast Milk of Lactating Women Treated with YORVIPATH

What this Trial Is About

This observational study focuses on lactating female participants who are receiving therapeutic doses of YORVIPATH palopegteriparatide as part of their usual medical care and who have chosen to breastfeed their infants. The purpose is to assess the potential transfer of palopegteriparatide into breast milk, providing important information about exposure during breastfeeding for females with hypoparathyroidism. Participants in this study are lactating females treated with YORVIPATH according to normal clinical practice. The study observes those who have been on a stable daily dose of YORVIPATH for at least 14 days prior to sample collection. This is an opportunistic study that does not involve changes to their treatment but monitors the presence of the drug in breast milk over a six-day period. During the study, participants provide breast milk samples to evaluate the transfer of palopegteriparatide. The main outcome measured is the amount of the drug present in breast milk over six days. Participants continue their usual care and dosing schedules, and researchers collect data without altering treatment. The total participation duration depends on dosing stability and sample collection timing, with no additional interventions beyond monitoring.

A Study to Assess the Amount of Palopegteriparatide in Breast Milk of Lactating Females Requiring YORVIPATH® (Palopegteriparatide)