Expanded Access Program of Palopegteriparatide in Patients With Hypoparathyroidism

Inclusion Criteria: Diagnosis of hypoparathyroidism. Patients with previous PTH-treatment experience. Serum albumin-adjusted calcium level ≥7.8 mg/dL and 25(OH) vitamin D in the normal range within 2 weeks before first dose. Body mass index (BMI) 17 - 40 kg/m2. Be willing and able to give written informed consent by signing an Institutional Review Board (IRB)-approved Informed Consent Form (ICF). Exclusion Criteria: Diagnosis of pseudohypoparathyroidism. Currently enrolled in an investigational drug or device study or has used an investigational drug or device within 30 days or 5 half-lives (whichever is longer) of Day 1. Severe renal impairment (estimated glomerular filtration rate <30 mL/min/1.73m2). Increased risk for osteosarcoma, such as those with Paget's disease of bone or unexplained elevations of alkaline phosphatase, hereditary disorders predisposing to osteosarcoma, or with a prior history of substantial external beam or implant radiation therapy involving the skeleton Active malignancy within past 2 years excluding successfully resected thyroid carcinoma and non-melanoma skin cancer. Severe or decompensated cardiac disease within 26 weeks, including but not limited to class IV or Stage D heart failure, unstable angina, myocardial infarction or uncontrolled arrhythmias. Pregnant or lactating females, or females intending to become pregnant. Known allergy and/or sensitivity to palopegteriparatide or its excipients or prior PTH therapy.