An observational study in Hypoparathyroidism, sponsored by Ascendis Pharma A/S. Recruiting at 1 site in United States. Open to female participants aged 15 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-03-02.
Sponsored by Ascendis Pharma A/S · Observational
The purpose of this registry study is to collect both prospective and retrospective data in women exposed to palopegteriparatide during pregnancy to assess risk of pregnancy and maternal complications, and adverse effects on the developing fetus, neonate, and infant and to assess infant outcomes through at least the first year of life.
Participants with exposure to at least one dose of YORVIPATH at any time within 15 days prior to conception or during pregnancy. Prospective and retrospective pregnancies may be reported.
Exclusion Criteria:
Pregnant women exposed to palopegteriparatide during pregnancy
Drug: Palopegteriparatide
Palopegteriparatide prescribed as per normal clinical practice
The number of fetuses as reported by HCP
Time frame: 21 months
Pregnancy outcomes
* Live birth (preterm delivery, full-term delivery) * Spontaneous abortion * Pregnancy termination * Fetal death/stillbirth * Molar or ectopic pregnancy
Time frame: 21 months
Number of congenital malformations identified in the developing fetus, neonate, or infant
Time frame: 21 months
Descriptive statistics of adverse events (AEs), including serious adverse events (SAEs)
Time frame: 21 months
Number of hospitalizations including reasons for hospitalization
Time frame: 21 months
Descriptive statistics of growth and development milestones as described by the Centers for Disease Control and Prevention (CDC 2021) or other accepted standard assessment
Time frame: 21 months
Number of signs of hypocalcemia or hypercalcemia
Time frame: 21 months
Descriptive statistics of infant developmental deficiency (CDC 2021)
Time frame: 21 months
Descriptive statistics of postnatal growth deficiency or failure to thrive (FTT)
Time frame: 21 months
Descriptive statistics of neonatal and infant mortality
Time frame: 21 months
Maternal complications of pregnancy
Including but not limited to * Premature rupture of membranes (PROM) * Preterm PROM (PPROM) * Pre-eclampsia * Gestational hypertension * Eclampsia * Proteinuria * Gestational diabetes * Intrauterine growth restriction (IUGR) * Polyhydramnios * Preterm delivery * Measures of fetal growth deficiency (e.g., small for gestational age)
Time frame: 21 months
Other maternal events of interest
Number of * AEs, including SAEs * Events specific to hypoparathyroidism (e.g., hypercalcemia, hypocalcemia). Serum calcium concentrations at each trimester (if available) and at birth
Time frame: 21 months
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Ascendis Pharma A/S