Actively Recruiting
Daily Palopegteriparatide Injections for Adolescents Aged 12 to Under 18 With Long-Term Hypoparathyroidism A Phase 3 Treatment Study
Led by Ascendis Pharma A/S · Updated on 2026-07-28
12
Participants Needed
3
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects and safety of once-daily palopegteriparatide injections in adolescents aged 12 to under 18 years who have long-term hypoparathyroidism. The study focuses on participants with clinically diagnosed hypoparathyroidism lasting at least 26 weeks and aims to understand how well this treatment works and its safety profile over a long period. Participants will receive palopegteriparatide by subcutaneous injection once daily for up to 234 weeks. During this time, researchers will monitor various health aspects including serum biochemistries, bone mineral density, renal calcifications, hospital visits, adverse events, and patient-reported symptom and impact scores. This is a single-group Phase 3 trial conducted in Europe. Participants will be involved in regular assessments throughout the study, including blood and urine tests, imaging for kidney calcifications, bone health evaluations, and symptom questionnaires. The main outcome is the percentage of participants achieving a specific efficacy endpoint at 26 weeks, with ongoing monitoring continuing through the full 234 weeks. Safety and treatment effects will be closely observed during the entire study period.
CONDITIONS
Brief Title
A Study to Test the Effects and Safety of Palopegteriparatide in Adolescents With Long-term Hypoparathyroidism
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males and females aged 12 to less than 18 years
- Diagnosed with postsurgical, autoimmune, genetic, or idiopathic chronic hypoparathyroidism lasting at least 26 weeks
- Normal serum levels of vitamin D and magnesium
- Estimated glomerular filtration rate (eGFR) of 30 mL/min/1.73 or higher
- Able to perform daily subcutaneous injections or have a caregiver who can
- Body mass index (BMI) Z-score between -2 and +3 SDS
- Provided written and signed informed consent
You will not qualify if you...
- Resistance to parathyroid hormone (PTH) with elevated PTH and low calcium levels
- Any other disease affecting calcium or PTH levels, such as active hyperthyroidism
- Use of loop diuretics, phosphate binders (except calcium), digoxin, lithium, methotrexate, high-dose biotin, or systemic corticosteroids beyond replacement therapy; short steroid use up to 2 weeks per year at certain doses allowed
- Use of thiazide diuretics
- Use of PTH-like drugs
- Use of medications affecting calcium and bone metabolism within 12 weeks before screening
- Use of osteoporosis treatments like bisphosphonates, denosumab, raloxifene, or romosozumab within 2 years before screening
- Non-hypocalcemic seizure disorder with seizure within 26 weeks before screening
- Increased risk for osteosarcoma
- Female participants who are pregnant, planning pregnancy, or breastfeeding
- Diagnosed drug or alcohol dependence within 3 years before screening
Research Team
A
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