rhPTH(1-84) for hypoparathyroidism: a randomized study of patient-reported outcomes
Primary result · Change in HypoPT-SD symptom subscale scoreResult — go to the resultDifference in least-squares mean changes −0.53 95% CI −0.90 to −0.15Authors' conclusion
rhPTH(1-84) alongside conventional therapy improved symptom burden (as measured by the HypoPT-SD) and HRQoL to a greater extent than conventional therapy alone in patients with symptomatic cHypoPT.
Study context
- Population
- Patients with symptomatic chronic hypoparathyroidism (cHypoPT)randomized
- Participants
- 93 patients
- Comparison
- rhPTH vs placebo, with conventional therapy
- rhPTH(1-84)n = 45
- Placebon = 48reference
- Primary endpoint
- Change from baseline in Hypoparathyroidism Symptom Diary (HypoPT-SD) symptom subscale score
- Follow-up
- Week 26
Methodological detailsdouble-blind, placebo-controlled, phase 3b-4
- Double-blind
- Placebo-controlled
- Phase 3b-4
Primary result
Change in HypoPT-SD symptom subscale score · baseline to week 26
Difference in least-squares mean changes
−0.53
95% CI −0.90 to −0.15
P = 0.003
rhPTH(1-84)vs Placebo
difference in least-squares mean changes −0.53 (95% CI −0.90 to −0.15); P = 0.003
As reported in the abstract
Secondary outcomes
Key secondary: change in FACIT-Fatigue and SF-36v2 PCS scores · baseline to week 26
- Changes in FACIT-Fatigue and SF-36v2 PCS significantly greater (improved) with rhPTH(1-84) vs placebo
Safety
- Safety profile consistent with previous findings; no new safety signals
Original publication
rhPTH(1-84) for hypoparathyroidism: a randomized study of patient-reported outcomes. Eur J Endocrinol. Published 25 July 2025. doi:10.
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