This trial will enroll adolescents between ages of ≥12 and \<18 years with clinically diagnosed hypoparathyroidism . The purpose of the study is to see how well treatment with once-daily palopegteriparatide works and how safe it is. At least 12 participants will receive palopegteriparatide for 234 weeks. This trial will be conducted in Europe.
1. Males and females, 12 to less than 18 years of age
2. Participants with postsurgical chronic hypoparathyroidism, or auto-immune, genetic, or idiopathic hypoparathyroidism for at least 26 weeks
3. Normal levels of serum 25(OH) vitamin D and magnesium
4. Estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73
1. Impaired responsiveness to PTH which is characterized as PTH-resistance, with elevated PTH levels in the setting of hypocalcemia
2. Any disease that might affect calcium metabolism or calcium-phosphate homeostasis or PTH levels other than hypoparathyroidism, such as active hyperthyroidism
3. Use of loop diuretics, phosphate binders (other than calcium supplements), digoxin, lithium, methotrexate, biotin >30 µg/day, or systemic corticosteroids (other than as replacement therapy). Short course use of steroids (≤2 weeks/year) equivalent to prednisone ≤60 mg/day is permitted
4. Use of thiazide diuretic
Single group
Palopegteriparatide
Combination productSubcutaneous injection for 234 weeks
Percentage of participants meeting the multicomponent efficacy endpoint at Week 26
The multi-component endpoint is the percentage of participants who met the following criteria at Week 26: 1) albumin-adjusted serum calcium within the normal range ; 2) independence from active vitamin D, and 3) independence from therapeutic doses of calcium
Percentage of participants meeting the multicomponent efficacy endpoint through Week 234
The multi-component endpoint is the percentage of participants who met the following criteria: 1) albumin-adjusted serum calcium within the normal range (8.3-10.6 mg/dL) 2) independence from active vitamin D; and 3) independence from therapeutic doses of calcium.
Serum biochemistries
Change from baseline and normalization of serum calcium, mmol/L
Serum biochemistries
Change from baseline and normalization of serum phosphate, mmol/L
Serum biochemistries
Change from baseline and normalization of serum creatinine, mL/min
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