rhPTH(1-84) for hypoparathyroidism: a randomized study of patient-reported outcomes.

Brandi ML, Vokes T, Appelman-Dijkstra NM, Ayodele O, Decallonne B, de Jongh R, Díaz-Curiel M, Fraser W, Finkelman RD, Heck A, Ing SW, Kamenický P and 16 more

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Khan AA, Kovacs CS, Lapauw B, Leese G, Mantovani G, Martínez Díaz-Guerra G, Masi L, Melo M, Palermo A, Reddy NL, Rejnmark L, Tokareva E, Vantyghem MC, Wang S, Warren M, Yan B

European journal of endocrinology1 Jul 2025Cited by 2 (Europe PMC)

PMID40711996DOI10.1093/ejendo/lvaf148PepBankPUB-40711996

Publisher page PubMedAsk about this study

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Summary

ObjectiveTo assess the impact of recombinant human parathyroid hormone (1-84) [rhPTH(1-84)] compared with placebo, in combination with conventional therapy with vitamin D and/or calcium supplements, on health-related quality of life (HRQoL) in patients with symptomatic chronic hypoparathyroidism (cHypoPT).DesignRandomized, double-blind, placebo-controlled, phase 3b-4 study (ClinicalTrials.gov ID: NCT03324880).MethodsEligible patients with symptomatic cHypoPT were randomized to receive subcutaneous rhPTH(1-84) 25-100 µg/day or placebo. The primary endpoint was the change from baseline to week 26 in Hypoparathyroidism Symptom Diary (HypoPT-SD) symptom subscale score. Key secondary endpoints were changes from baseline to week 26 in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue and in 36-item Short Form Health Survey physical component summary (SF-36v2 PCS).ResultsIn total, 93 patients were randomized to receive treatment: 45 received rhPTH(1-84) and 48 received placebo. Change from baseline to week 26 in HypoPT-SD symptom subscale score was significantly greater (improved) in the rhPTH(1-84) group than in the placebo group (difference in least-squares mean changes, -0.53; 95% confidence interval, -0.90 to -0.15, P = .003). Key secondary endpoints, changes between baseline and week 26 in the FACIT-Fatigue and SF-36v2 PCS scores were also significantly greater (improved) in the rhPTH(1-84) group than in the placebo group. The safety profile of rhPTH(1-84) was consistent with previous findings, and no new safety signals were identified.ConclusionsrhPTH(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.

CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study4

4 results from studies that gave the peptide. 4 results from people.

01HumanRandomized controlled trialEfficacy outcome
In symptomatic chronic hypoparathyroidism, rhPTH(1-84) improved symptom subscale scores more than placebo at week 26, with a mean-change difference of -0.53.
In plain wordsIn symptomatic chronic hypoparathyroidism, rhPTH(1-84) reduced symptom scores more than placebo at week 26.
Peptide
PTH 1-84 (parathyroid hormone)
Outcome
DecreaseHypoPT-SD symptom subscale change
Study
n = 93
Comparator
Placebo
Analysis
Primary
Outcome group
Quality of life · Endocrine and hormones
Studied dose
25-100 µg/day · subcutaneousAs given in this study (human).
Measurements
Least-squares mean change difference
−0.53
rhPTH versus placebo
95% CI
−0.9 to −0.15
difference
P
0.003
comparison
Source sentences
Summary
Change from baseline to week 26 in HypoPT-SD symptom subscale score was significantly greater (improved) in the rhPTH(1-84) group than in the placebo group (difference in least-squares mean changes, -0.53; 95% confidence interval, -0.90 to -0.15, P = .003).
2 context sentences(design, population, supporting numbers)
Summary · context
Randomized, double-blind, placebo-controlled, phase 3b-4 study (ClinicalTrials.gov ID: NCT03324880).
Summary · context
Eligible patients with symptomatic cHypoPT were randomized to receive subcutaneous rhPTH(1-84) 25-100 µg/day or placebo.
Show in the study text Report a problemFND-4071199601
02HumanRandomized controlled trialEfficacy outcome
In symptomatic chronic hypoparathyroidism, rhPTH(1-84) improved FACIT-Fatigue scores more than placebo between baseline and week 26.
In plain wordsIn symptomatic chronic hypoparathyroidism, rhPTH(1-84) improved fatigue scores more than placebo between baseline and week 26.
Peptide
PTH 1-84 (parathyroid hormone)
Outcome
IncreaseFACIT-Fatigue score change
Study
n = 93
Comparator
Placebo
Analysis
Secondary
Outcome group
Quality of life · Endocrine and hormones
Studied dose
25-100 µg/day · subcutaneousAs given in this study (human).
Source sentences
Summary
Key secondary endpoints, changes between baseline and week 26 in the FACIT-Fatigue and SF-36v2 PCS scores were also significantly greater (improved) in the rhPTH(1-84) group than in the placebo group.
2 context sentences(design, population, supporting numbers)
Summary · context
Randomized, double-blind, placebo-controlled, phase 3b-4 study (ClinicalTrials.gov ID: NCT03324880).
Summary · context
Eligible patients with symptomatic cHypoPT were randomized to receive subcutaneous rhPTH(1-84) 25-100 µg/day or placebo.
Show in the study text Report a problemFND-4071199602
03HumanRandomized controlled trialEfficacy outcome
In symptomatic chronic hypoparathyroidism, rhPTH(1-84) improved SF-36v2 physical component summary scores more than placebo between baseline and week 26.
In plain wordsIn symptomatic chronic hypoparathyroidism, rhPTH(1-84) improved physical health scores more than placebo between baseline and week 26.
Peptide
PTH 1-84 (parathyroid hormone)
Outcome
IncreaseSF-36v2 physical component score change
Study
n = 93
Comparator
Placebo
Analysis
Secondary
Outcome group
Quality of life · Endocrine and hormones
Studied dose
25-100 µg/day · subcutaneousAs given in this study (human).
Source sentences
Summary
Key secondary endpoints, changes between baseline and week 26 in the FACIT-Fatigue and SF-36v2 PCS scores were also significantly greater (improved) in the rhPTH(1-84) group than in the placebo group.
2 context sentences(design, population, supporting numbers)
Summary · context
Randomized, double-blind, placebo-controlled, phase 3b-4 study (ClinicalTrials.gov ID: NCT03324880).
Summary · context
Eligible patients with symptomatic cHypoPT were randomized to receive subcutaneous rhPTH(1-84) 25-100 µg/day or placebo.
Show in the study text Report a problemFND-4071199603
04HumanNon-randomized trialSafety outcome
In symptomatic chronic hypoparathyroidism patients receiving rhPTH(1-84), no new safety signals were identified.
In plain wordsIn symptomatic chronic hypoparathyroidism patients receiving rhPTH(1-84), no new safety signals were identified.
Peptide
PTH 1-84 (parathyroid hormone)
Outcome
Not applicableNew safety signals
Study
n = 45
Outcome group
Adverse events · Whole body
Studied dose
25-100 µg/day · subcutaneousAs given in this study (human).
Source sentences
Summary
The safety profile of rhPTH(1-84) was consistent with previous findings, and no new safety signals were identified.
2 context sentences(design, population, supporting numbers)
Summary · context
Randomized, double-blind, placebo-controlled, phase 3b-4 study (ClinicalTrials.gov ID: NCT03324880).
Summary · context
Eligible patients with symptomatic cHypoPT were randomized to receive subcutaneous rhPTH(1-84) 25-100 µg/day or placebo.
Show in the study text Report a problemFND-4071199604

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 4Results postedNCT03324880

A Study to Learn if Recombinant Human Parathyroid Hormone [rhPTH(1-84)] Can Improve Symptoms and Metabolic Control in Adults With Hypoparathyroidism (BALANCE)

Shiren = 9324 Jan 2018 to 19 May 2022

Hypoparathyroidism

Trial page ClinicalTrials.govUpdated 9 Jun 2023

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
28 Oct 2026, 02:03 UTC
Study results updated
Version 1
27 Oct 2026, 16:37 UTC
First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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