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NCT Number: NCT07345494

A Global Pregnancy Registry to Assess Maternal, Fetal, and Infant Outcomes Following Exposure to YORVIPATH® (Palopegteriparatide) During Pregnancy and Breastfeeding

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.

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Key information

Conditions

Hypoparathyroidism Endocrine System Diseases Parathyroid Diseases

Age range

15 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Ascendis Investigational Site

Morgantown, West Virginia, 26508, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants aged 15 to 50 years
  • Participants with exposure to at least one dose of YORVIPATH at any time within 15 days prior to conception and/or during pregnancy. The timeframe of 15 days prior to conception is calculated based on 5 times the YORVIPATH half life of ~ 60 hours
  • Participants providing written informed consent, verbal consent, or eConsent (depending on country regulations) and a Medical Release of Information. For adolescents under the age of majority, verbal or written informed assent by the pregnant minor (where applicable) and verbal or written informed consent by the parent/legal guardian will be obtained.

Exclusion criteria

  • Pregnancies in which only the male partner is exposed to at least one dose of YORVIPATH.

Treatment and study plan

Palopegteriparatide

Drug

Palopegteriparatide prescribed as per normal clinical practice

Primary outcomes

  1. The number of fetuses as reported by HCP

    Time frame: 21 months

  2. Pregnancy outcomes

    Time frame: 21 months

    • Live birth (preterm delivery, full-term delivery)
    • Spontaneous abortion
    • Pregnancy termination
    • Fetal death/stillbirth
    • Molar or ectopic pregnancy

  3. Number of congenital malformations identified in the developing fetus, neonate, or infant

    Time frame: 21 months

  4. Descriptive statistics of adverse events (AEs), including serious adverse events (SAEs)

    Time frame: 21 months

  5. Number of hospitalizations including reasons for hospitalization

    Time frame: 21 months

  6. 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

  7. Number of signs of hypocalcemia or hypercalcemia

    Time frame: 21 months

  8. Descriptive statistics of infant developmental deficiency (CDC 2021)

    Time frame: 21 months

  9. Descriptive statistics of postnatal growth deficiency or failure to thrive (FTT)

    Time frame: 21 months

  10. Descriptive statistics of neonatal and infant mortality

    Time frame: 21 months

  11. Maternal complications of pregnancy

    Time frame: 21 months

    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)

  12. Other maternal events of interest

    Time frame: 21 months

    Number of

    • AEs, including SAEs
    • Events specific to hypoparathyroidism (e.g., hypercalcemia, hypocalcemia). Serum calcium concentrations at each trimester (if available) and at birth

Study contacts

Contact information is provided by the study sponsor or research team.

Yorvipath Pregnancy Inquiries

CONTACT

[email protected]

877-229-2184

Sponsors and collaborators

Lead sponsor

Ascendis Pharma A/S

Industry

Registry information

Important dates

Study start
2026
Primary completion
2036
Study completion
2036
First posted
Jan 15, 2026
Registry last updated
Mar 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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