Early U.S. Real-World Treatment Patterns and Outcomes in Palopegteriparatide Treatment for Patients With Hypoparathyroidism
Authors' conclusion
This real-world analysis of palopegteriparatide treatment of hypoparathyroidism outside of a clinical trial setting reaffirms its efficacy and safety profile and provides insights into outcomes associated with different treatment transition practices.
Study context
- Population
- Adults with hypoparathyroidism enrolled in the U.S. expanded access program as of October 2024 who provided consent; 95.1% previously treated with short-lived parathyroid hormone (PTH) therapy135 enrolled
- Participants
- 123 adults
- Exposure
- Direct switch vs Nondirect switch
- Direct switchn = 62
- Outcome
- Independence from conventional therapy (no calcitriol and ≤600 mg/day elemental calcium)
- Follow-up
- Up to 12 months
Methodological detailsexpanded access program analysis, U.S. expanded access program, up to 12 months of treatment
- Expanded access program analysis
- U.S. expanded access program
- Up to 12 months of treatment
Main finding
As reported in the abstract
- Proportion achieving independence from conventional therapy increased over 12 months with palopegteriparatide
- Mean serum calcium remained within reference range (8.3-10.6 mg/dL)
Observational data: associations, not effects.
Further findings
Palopegteriparatide dose, direct vs nondirect switch
- No clinically meaningful difference (>3 μg) in dose between direct and nondirect switch, with similar trend over time
Safety
Adverse events · up to 12 months
- No new safety signals identified
Original publication
Early U.S. Real-World Treatment Patterns and Outcomes in Palopegteriparatide Treatment for Patients With Hypoparathyroidism. Endocr Pract. Published 20 August 2025. doi:10.
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