Extended Treatment With Recombinant Human Parathyroid Hormone (1-84) in Adult Patients With Chronic Hypoparathyroidism
Authors' conclusion
The effects of rhPTH(1-84) on biochemical, skeletal, and health-related quality-of-life parameters did not wane with extended use.
Study context
- Population
- Adults with chronic hypoparathyroidism previously exposed to rhPTH(1–84) (mean exposure 8.5 [SD 3.5] years); mean age 51.9 years, 79.5% female, 97.4% White
- Participants
- 39 adults
- Outcome
- Albumin-adjusted serum calcium levels
Methodological detailsphase 4, single-center, single-arm, 3-year extension of the phase 3 Hypo Extended (HEXT) study
- Phase 4
- Single-center
- Single-arm
- 3-year extension of the phase 3 HEXT study
Main finding
As reported in the abstract
Albumin-adjusted serum calcium
- Mean albumin-adjusted serum calcium concentrations were within the target range
- Descriptive statistics
Further findings
Serum phosphate, calcium-phosphate product, 24-h urinary calcium · end of treatment
- Mean levels within reference ranges
Supplemental calcium and active vitamin D doses
- Mean doses maintained throughout the study
Bone turnover markers and BMD · baseline to end of treatment
- BTM levels maintained; no clinically relevant changes in BMD
Health-related quality of life
- Patient-reported scores generally maintained throughout the study
Safety
- Treatment-related adverse events
- 4
- No new safety signals identified
Original publication
Extended Treatment With Recombinant Human Parathyroid Hormone (1-84) in Adult Patients With Chronic Hypoparathyroidism. Endocr Pract. Published 10 December 2023. doi:10. 1016/ j. eprac. 2023. 12. 001
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