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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Palopegteriparatide | Pregnant women exposed to palopegteriparatide during pregnancy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Palopegteriparatide | Drug | Palopegteriparatide prescribed as per normal clinical practice |
|
| Measure | Description | Time Frame |
|---|---|---|
| The number of fetuses as reported by HCP | 21 months | |
| Pregnancy outcomes |
| 21 months |
| Number of congenital malformations identified in the developing fetus, neonate, or infant | 21 months | |
| Descriptive statistics of adverse events (AEs), including serious adverse events (SAEs) | 21 months | |
| Number of hospitalizations including reasons for hospitalization | 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 | 21 months | |
| Number of signs of hypocalcemia or hypercalcemia | 21 months | |
| Descriptive statistics of infant developmental deficiency (CDC 2021) | 21 months | |
| Descriptive statistics of postnatal growth deficiency or failure to thrive (FTT) | 21 months | |
| Descriptive statistics of neonatal and infant mortality |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yorvipath Pregnancy Inquiries | Contact | 877-229-2184 | yorvipathpregnancy@ubc.com |
| Name | Affiliation | Role |
|---|---|---|
| Medical Director, MD | Ascendis Pharma A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ascendis Investigational Site | Recruiting | Morgantown | West Virginia | 26508 | United States |
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| 21 months |
| Maternal complications of pregnancy | Including but not limited to
| 21 months |
| Other maternal events of interest | Number of
| 21 months |
| ID | Term |
|---|---|
| D007011 | Hypoparathyroidism |
| ID | Term |
|---|---|
| D010279 | Parathyroid Diseases |
| D004700 | Endocrine System Diseases |
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