Evidence map›Paper›PMID 38691316›Full record

Trial reportAdvances in therapy2024

Palopegteriparatide Treatment Improves Renal Function in Adults with Chronic Hypoparathyroidism: 1-Year Results from the Phase 3 PaTHway Trial.

Lars Rejnmark, Elvira O Gosmanova, Aliya A Khan, Noriko Makita, Yasuo Imanishi, Yasuhiro Takeuchi, Stuart Sprague, Dolores M Shoback, Lynn Kohlmeier, Mishaela R Rubin and 11 more

2 registry-linked trialsOpen access · hybridAbstract readRandomized Controlled TrialClinical Trial, Phase IIIMulticenter Study
In one paragraph

Trial report in Advances in therapy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 23 papers.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed
14.3field-weighted citation impact, top 1% of its field
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.

NCT04701203 phase3completednot on this map

PaTHway TRIAL: A Phase 3, 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 Bone Diseases A/SRan2021 to 2025Enrolled84ConditionsHypoparathyroidism, Endocrine System Diseases, Parathyroid DiseasesArmsTransCon PTH, Placebo
NCT07299838 completednot on this map

Real-World Data for Effectiveness and Safety of Palopegteriparatide in Patients With Chronic Hypoparathyroidism in Greece

TypeobservationalSponsorNational and Kapodistrian University of AthensRan2024 to 2025Enrolled90ConditionsHypoparathyroidism
3 · Its place in the literature

Who cites it

23 citing papers in PubMed, 25 citations in OpenAlex.

  1. Sustained improvement in renal function with palopegteriparatide in adults with chronic hypoparathyroidism: 2-year results from the phase 3 PaTHway-trial.Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research · 2026
    Trial
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  9. Review
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  11. Review
  12. Advances in Parathyroid Hormone-based medicines.Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research · 2025
    Review
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  15. Review
  16. Review
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  20. 2024 FDA TIDES (Peptides and Oligonucleotides) Harvest.Pharmaceuticals (Basel, Switzerland) · 2025
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

21 authors at 15 institutions in 6 countries.

Lars RejnmarkAarhus University Hospital, Aarhus, Denmark.
Elvira O GosmanovaAlbany Medical College, Albany, NY, USA.
Aliya A KhanMcMaster University, Hamilton, ON, Canada.
Noriko MakitaThe University of Tokyo Graduate School of Medicine, Tokyo, Japan.
Yasuo ImanishiOsaka Metropolitan University Graduate School of Medicine, Osaka, Japan.
Yasuhiro TakeuchiToranomon Hospital and Okinaka Memorial Institute for Medical Research, Tokyo, Japan.
Stuart SpragueNorthShore University Health System-University of Chicago Pritzker School of Medicine, Chicago, IL, USA.
Dolores M ShobackUniversity of California, San Francisco and VA Medical Center, San Francisco, CA, USA.
Lynn KohlmeierEndocrinology and Spokane Osteoporosis, Spokane, WA, USA.
Mishaela R RubinColumbia University, New York, NY, USA.
Andrea PalermoFondazione Policlinico Campus Bio-Medico and Unit of Endocrinology and Diabetes, Campus Bio-Medico University, Rome, Italy.
Peter SchwarzRigshospitalet, Copenhagen, Denmark.
Claudia GagnonCHU de Québec-Université Laval Research Centre and Department of Medicine, Université Laval, Quebec City, QC, Canada.
Elena TsourdiDepartment of Medicine III and Center for Healthy Aging, Technische Universität Dresden, Dresden, Germany.
Carol ZhaoAscendis Pharma Inc., 1000 Page Mill Rd., Palo Alto, CA, 94304, USA.
Michael A MakaraAscendis Pharma Inc., 1000 Page Mill Rd., Palo Alto, CA, 94304, USA.
Michael S OminskyAscendis Pharma Inc., 1000 Page Mill Rd., Palo Alto, CA, 94304, USA.
Bryant LaiAscendis Pharma Inc., 1000 Page Mill Rd., Palo Alto, CA, 94304, USA.
Jenny UkenaAscendis Pharma Inc., 1000 Page Mill Rd., Palo Alto, CA, 94304, USA.
Christopher T SibleyAscendis Pharma Inc., 1000 Page Mill Rd., Palo Alto, CA, 94304, USA.
Aimee D ShuAscendis Pharma Inc., 1000 Page Mill Rd., Palo Alto, CA, 94304, USA. ads@ascendispharma.com.ORCID 0000-0003-1801-5289
Aarhus University Hospital · DKAlbany Medical Center Hospital · USAscendis Pharma (Denmark) · DKBone Health and Osteoporosis Foundation · USCampus Bio Medico University Hospital · ITColumbia University · USMcMaster University · CANorthShore University HealthSystem · USOsaka Metropolitan University · JPRigshospitalet · DKSan Francisco VA Medical Center · USTechnische Universität Dresden · DEThe University of Tokyo · JPToranomon Hospital · JPUniversité Laval · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionIndividuals with chronic hypoparathyroidism managed with conventional therapy (active vitamin D and calcium) have an increased risk for renal dysfunction versus age- and sex-matched controls. Treatments that replace the physiologic effects of parathyroid hormone (PTH) while reducing the need for conventional therapy may help prevent a decline in renal function in this population. This post hoc analysis examined the impact of palopegteriparatide treatment on renal function in adults with chronic hypoparathyroidism.

methodsPaTHway is a phase 3 trial of palopegteriparatide in adults with chronic hypoparathyroidism that included a randomized, double-blind, placebo-controlled 26-week period followed by an ongoing 156-week open-label extension (OLE) period. Changes in renal function over 52 weeks (26 weeks blinded + 26 weeks OLE) were assessed using estimated glomerular filtration rate (eGFR). A subgroup analysis was performed with participants stratified by baseline eGFR < 60 or ≥ 60 mL/min/1.73 m

resultsAt week 52, over 95% (78/82) of participants remained enrolled in the OLE and of those, 86% maintained normocalcemia and 95% achieved independence from conventional therapy (no active vitamin D and ≤ 600 mg/day of calcium), with none requiring active vitamin D. Treatment with palopegteriparatide over 52 weeks resulted in a mean (SD) increase in eGFR of 9.3 (11.7) mL/min/1.73 m

conclusionIn this post hoc analysis of the PaTHway trial, palopegteriparatide treatment was associated with significantly improved eGFR at week 52 in addition to previously reported maintenance and normalization of serum and urine biochemistries. Further investigation of palopegteriparatide for the preservation of renal function in hypoparathyroidism is warranted.

trial registrationClinicalTrials.gov NCT04701203.

Indexed as

Glomerular Filtration RateHypoparathyroidismParathyroid HormonePeptidesAdultAgedCalciumChronic DiseaseDouble-Blind MethodFemaleHumansMaleMiddle AgedTreatment OutcomeVitamin DCalciumPalopegteriparatideParathyroid HormonePeptidesVitamin DClinical trialGlomerular filtration rateHypoparathyroidismKidneyPalopegteriparatideParathyroid hormoneRenal diseaseTransCon PTH

Identifiers

PMID38691316
PMCPMC11133178
OpenAlexW4396552446

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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 OpenQuestion graph.