Evidence map›Paper›PMID 41365829›Full record

Trial reportThe Journal of clinical endocrinology and metabolism2026

Patient-reported outcomes in palopegteriparatide-treated adults with hypoparathyroidism: PaTH Forward trial extension.

Mishaela Rubin, Andrea Palermo, Tamara Vokes, Aliya A Khan, Peter Schwarz, Filomena Cetani, Uberto Pagotto, Elena Tsourdi, Tanja Sikjaer, Kathryn M Pfeiffer and 6 more

Erratum issued Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The Journal of clinical endocrinology and metabolism, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT04009291 (PaTH Forward), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04009291 phase2completednot on this map

PaTH Forward: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial With an Open-Label Extension, Investigating the Safety, Tolerability and Efficacy of TransCon PTH Administered Subcutaneously Daily in Adults With Hypoparathyroidism

TypeinterventionalSponsorAscendis Pharma A/SRan2019 to 2025Enrolled59ConditionsHypoparathyroidism, Endocrine System Diseases, Parathyroid DiseasesArmsTransCon PTH, Placebo for TransCon PTH
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Observational
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

16 authors.

Mishaela RubinDepartment of Endocrinology, Columbia University, New York, NY 10032, USA.
Andrea PalermoResearch Unit of Metabolic Bone and Thyroid Disorders, Department of Medicine and Surgery, Università Campus Bio-Medico di Roma, 00128 Rome, Italy.ORCID 0000-0002-1143-4926
Tamara VokesDepartment of Medicine - Endocrinology, The University of Chicago, Chicago, IL 60637, USA.
Aliya A KhanDepartment of Clinical Medicine, McMaster University, Hamilton, ON L8S 4L8, Canada.
Peter SchwarzDepartment of Endocrinology, Rigshospitalet and University of Copenhagen, 2100 Copenhagen, Denmark.
Filomena CetaniDepartment of Clinical and Experimental Medicine, Endocrine Unit, University of Pisa, 56124 Pisa, Italy.
Uberto PagottoDivision of Endocrinology and Diabetes Prevention and Care, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Department of Medical and Surgical Sciences, Alma Mater Studiorum University of Bologna, 40100 Bologna BO, Italy.ORCID 0000-0003-4182-3110
Elena TsourdiDepartment of Medicine III and Center for Healthy Aging, Technische Universität Dresden, 01069 Dresden, Germany.
Tanja SikjaerDepartment of Endocrinology and Internal Medicine, Aarhus University Hospital, 8200 Aarhus N, Denmark.
Kathryn M PfeifferThe Brod Group, Mill Valley, CA 94941, USA.
Meryl BrodThe Brod Group, Mill Valley, CA 94941, USA.
Lori D McLeodRTI Health Solutions, Research Triangle Park, NC 27709, USA.
Carol ZhaoEndocrine and Rare Disease Medical Sciences, Ascendis Pharma, Inc, Palo Alto, CA 94304, USA.
Wahidullah NooriEndocrine and Rare Disease Medical Sciences, Ascendis Pharma, Inc, Palo Alto, CA 94304, USA.
Aimee D ShuEndocrine and Rare Disease Medical Sciences, Ascendis Pharma, Inc, Palo Alto, CA 94304, USA.
Alden R SmithEndocrine and Rare Disease Medical Sciences, Ascendis Pharma, Inc, Palo Alto, CA 94304, USA.ORCID 0000-0003-1582-534X

Funding

Ascendis Pharma Bone Diseases A/S 2018-004815-33Ascendis Pharma Bone Diseases A/S NCT04009291
6 · The paper itself

Abstract

contextIndividuals with hypoparathyroidism experience a range of physical and cognitive symptoms and reduced quality of life (QoL) despite management with conventional therapy (active vitamin D and calcium).

objectiveThis analysis investigated the long-term impact of parathyroid hormone (PTH) replacement therapy with palopegteriparatide (YORVIPATH®) on symptoms, daily functioning, and well-being in adults with chronic hypoparathyroidism. Associations between patient characteristics and changes in patient-reported outcomes (PROs) were also analyzed.

methodsPaTH Forward was a phase 2 clinical trial of palopegteriparatide with a 4-week randomized, double-blind, placebo-controlled period followed by an open-label extension period lasting through trial week 266. PRO measures were collected at baseline, weeks 4, 12, 26, 58, and annually thereafter through the end of the trial. The Hypoparathyroidism Patient Experience Scales (HPES) assess disease-specific symptoms and impacts on functioning and well-being. The Short Form Health Survey (SF-36v2) measures general health-related QoL. Data were analyzed using descriptive statistics and Mixed Models for Repeated Measures.

resultsPalopegteriparatide treatment demonstrated significant improvements from baseline in disease-specific symptoms and impacts on daily functioning and well-being at week 12, which were sustained through week 110. Mean changes in PROs met thresholds for clinically meaningful within-patient improvement. Significant improvements in general health-related QoL were also shown in SF-36v2 scores. Results were generally similar across demographics and patient characteristics.

conclusionThrough week 110 of the PaTH Forward trial, PTH replacement therapy with palopegteriparatide was associated with significant improvements in disease-specific symptoms and impacts on daily functioning and well-being, as well as general health-related QoL.

Indexed as

HypoparathyroidismPatient Reported Outcome MeasuresAdultAgedDouble-Blind MethodFemaleHormone Replacement TherapyHumansMaleMiddle AgedParathyroid HormoneQuality of LifeTreatment OutcomeParathyroid Hormonehypoparathyroidismpalopegteriparatidepatient-reported outcomesquality of life

Identifiers

PMID41365829
PMCPMC13017087

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.