Osteoporosis, bone & mineral

Extended Treatment With Recombinant Human Parathyroid Hormone (1-84) in Adult Patients With Chronic Hypoparathyroidism

Endocr PractPublished Open-label extension study

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

Composed by AI from the published abstract and checked against it. How Briefs are made →

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