RecruitingNot Applicable

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

United States50 participantsStarted 2026-02-18

Plain-language summary

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.

Who can participate

Age range

15 Years – 50 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The number of fetuses as reported by HCP

Timeframe: 21 months

Pregnancy outcomes

Timeframe: 21 months

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

Timeframe: 21 months

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

Timeframe: 21 months

Number of hospitalizations including reasons for hospitalization

Timeframe: 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

Timeframe: 21 months

Number of signs of hypocalcemia or hypercalcemia

Timeframe: 21 months

Trial details

NCT IDNCT07345494

SponsorAscendis Pharma A/S

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2036-01

Contact for this trial

Yorvipath Pregnancy Inquiries

877-229-2184 yorvipathpregnancy@ubc.com

View on ClinicalTrials.gov More Hypoparathyroidism trials

Plain-language summary

Who can participate

Age range

15 Years – 50 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

The number of fetuses as reported by HCP

Timeframe: 21 months

Pregnancy outcomes

Timeframe: 21 months

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

Timeframe: 21 months

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

Timeframe: 21 months

Number of hospitalizations including reasons for hospitalization

Timeframe: 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

Timeframe: 21 months

Number of signs of hypocalcemia or hypercalcemia

Timeframe: 21 months