Efficacy and Safety of Parathyroid Hormone Replacement With TransCon Parathyroid Hormone (PTH) in Hypoparathyroidism: 26-Week Results From the Phase 3 PaTHway Trial
Authors' conclusion
In conclusion, TransCon PTH maintained normocalcemia while permitting independence from conventional therapy and was well-tolerated in individuals with hypoparathyroidism.
Study context
- Population
- Individuals with hypoparathyroidism on conventional therapy (active vitamin D and calcium)randomized 3:1
- Participants
- 84 individuals
- Comparison
- Once-daily TransCon PTH vs placebo, both with conventional therapy
- Primary endpoint
- Composite:
- Normal albumin-adjusted serum calcium (8.3-10.6 mg/dL)
- Independence from conventional therapy (no active vitamin D and ≤600 mg/d calcium)
- No increase in study drug over 4 weeks before week 26
- Follow-up
- Week 26
Methodological detailsdouble-blind, placebo-controlled, phase 3, Study drug and conventional therapy titrated by a serum calcium-guided dosing algorithm
- Double-blind
- Placebo-controlled
- Phase 3
- Study drug and conventional therapy titrated by a serum calcium-guided dosing algorithm
Primary result
As reported in the abstract
Composite primary efficacy endpoint met
P < 0.0001
Secondary outcomes
- Independence from conventional therapy — TransCon PTH
- 93%
- Key secondary endpoints: Hypoparathyroidism Patient Experience Scale (HPES) domain scores and SF-36 Physical Functioning
- all p < 0.01
- Key secondary endpoints: HPES domain scores and SF-36 Physical Functioning · significant improvement
- P = 0.0347
- Key secondary endpoints: HPES domain scores and SF-36 Physical Functioning: significant improvement in all key secondary HPES domain scores
- Independence from conventional therapy: 57/61
24-hour urine calcium
- TransCon PTH normalized mean 24-hour urine calcium
Safety
Adverse events · 26 weeks
- Adverse events — Mild adverse events
- 46%
- Adverse events — Moderate adverse events
- 46%
Adverse events · 26 weeks
- No study drug-related withdrawals occurred
Original publication
Efficacy and Safety of Parathyroid Hormone Replacement With TransCon PTH in Hypoparathyroidism: 26-Week Results From the Phase 3 PaTHway Trial. J Bone Miner Res. Published 21 October 2022. doi:10.
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