Information for Health Care Providers

Ascendis Pharma, the manufacturer of YORVIPATH® (palopegteriparatide), is conducting two clinical observational studies:

YORVIPATH Pregnancy Safety Study

  • 50 women needed
  • Global study (starting in US first)

YORVIPATH Lactation Study

  • 10 breastfeeding females needed
  • US only

These studies are designed to collect real-world data on the use of YORVIPATH in pregnant and lactating women who are currently receiving therapeutic doses of YORVIPATH as part of their usual care and who have chosen to breastfeed their infant(s).

Specifically, they will evaluate:

  • The risk of pregnancy and maternal complications
  • Potential effects on fetal development
  • Neonatal and infant health outcomes following in utero or breast milk exposure
  • Safety outcomes for lactating women who continue YORVIPATH treatment
  • The transfer of palopegteriparatide into human breast milk of lactating women

Eligibility Criteria

Pregnancy Safety Study Criteria:

  • Women age 15 - 50
  • Received at least one dose of YORVIPATH within 15 days prior to conception and/or during pregnancy

Lactation Safety Study Criteria:

  • Women enrolled in the YORVIPATH Pregnancy Safety Study
  • Lactating females currently receiving therapeutic doses of YORVIPATH as part of their usual care and who have chosen to breastfeed their infant(s), and have been taking YORVIPATH for at least 14 days prior to sample collection

What is required for HCPs?

As these are both observational studies, no additional tests or visits are required, other than what would be regularly scheduled as part of the patient's standard of care.

What is required for your patients?

Participation in the Pregnancy Safety Study may last up to 21 months in total: 9 months during pregnancy and 12 months after the baby is born.

Patients/participants will be contacted once per trimester, at the estimated date of delivery, and when their baby is 3, 6, 9 and 12 months of age to provide basic information about their pregnancy and their baby's health.

Participation in the Lactation Safety Study will take about 2 days in total. It includes a 24-hour breast milk collection that begins at least 2 weeks after a woman's baby is born. A study nurse will visit participants at their home twice—once before and once after the collection. These visits will be scheduled at times that work best for the new mom and her family.

Patients may be compensated for their time and participation.

To enroll a patient