Evidence map›Paper›PMID 42166177›Full record

Trial reportJournal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research2026

Sustained improvement in renal function with palopegteriparatide in adults with chronic hypoparathyroidism: 2-year results from the phase 3 PaTHway-trial.

Lars Rejnmark, Elvira O Gosmanova, Aliya A Khan, Stuart Sprague, Dolores M Shoback, Lynn Kohlmeier, Mishaela R Rubin, Andrea Palermo, Peter Schwarz, Claudia Gagnon and 13 more

Abstract readClinical Trial, Phase IIIRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. 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

23 authors.

Lars RejnmarkDepartment of Clinical Medicine and Endocrinology, Aarhus University Hospital, Aarhus, 8200 Aarhus N, Denmark.
Elvira O GosmanovaNephrology Section, Department of Medicine, Albany Stratton VA Medical Center, Albany, NY 12008, United States.ORCID 0000-0001-8392-8004
Aliya A KhanDivisions Endocrinology and Metabolism and Geriatrics, Department of Medicine, McMaster University, Hamilton, ON, L8S 4L8, Canada.ORCID 0000-0003-3733-8956
Stuart SpragueDivision of Nephrology and Hypertension, NorthShore University Health System, Evanston, IL 60201, United States.
Dolores M ShobackEndocrine Research Unit, University of California San Francisco Medical Center, San Francisco, CA 94143, United States.
Lynn KohlmeierSpokane Osteoporosis and Endocrinology, Arthritis Northwest Research Center, Spokane, WA 99223, United States.
Mishaela R RubinDepartment of Endocrinology, Columbia University, New York, NY 10032, United States.
Andrea PalermoEndocrinology and Diabetes Unit, Campus Bio-Medico University of Rome, Roma, 00128, Italy.ORCID 0000-0002-1143-4926
Peter SchwarzDepartment of Endocrinology, Rigshospitalet, Copenhagen, 2100, Denmark.ORCID 0000-0002-0483-8594
Claudia GagnonFaculté de médecine, Université Laval, Quebec City, QC, G1V 0A6, Canada.ORCID 0000-0001-9623-962X
Elena TsourdiDepartment of Medicine III and Center for Healthy Aging, Dresden University of Technology, Dresden, 01307, Germany.
Yasuhiro TakeuchiEndocrine Center, Toranomon Hospital Kajigaya, Kawasaki, 213-8587, Japan.
Noriko MakitaDivision of Nephrology and Endocrinology, The University of Tokyo Hospital, Tokyo, 113-8655, Japan.ORCID 0000-0002-5722-115X
Yasuo ImanishiDepartment of Clinical Medical Science, Osaka Metropolitan University Graduate School of Medicine, Osaka, 545-8585, Japan.
Neil GittoesCentre for Endocrinology, Diabetes and Metabolism, Queen Elizabeth Hospital Birmingham, Birmingham, B15 2GW, United Kingdom.
Juan J DíezDepartment of Endocrinology, Hospital Universitario Puerta de Hierro Majadahonda, Majadahonda, 28220, Spain.
Caroline Prot-BertoyeService de Physiologie-Explorations Fonctionnelles, Hôpital Européen Georges Pompidou, Paris, 75015, France.
Bryant LaiAscendis Pharma, LLC, Palo Alto, CA 94304, United States.
Carol ZhaoAscendis Pharma, LLC, Palo Alto, CA 94304, United States.
Jenny UkenaAscendis Pharma, LLC, Palo Alto, CA 94304, United States.
Michael A MakaraAscendis Pharma, LLC, Palo Alto, CA 94304, United States.
Christopher T SibleyAscendis Pharma, LLC, Palo Alto, CA 94304, United States.
Aimee D ShuAscendis Pharma, LLC, Palo Alto, CA 94304, United States.ORCID 0000-0003-1801-5289

Funding

Ascendis Pharma Bone DiseasesPaTHway trial NCT04701203
6 · The paper itself

Abstract

The PaTHway clinical trial demonstrated sustained efficacy, safety, and tolerability of daily palopegteriparatide in the treatment of adults with hypoparathyroidism. Palopegteriparatide treatment was also associated with improvements in estimated glomerular filtration rate (eGFR) over 52 wk in a post hoc analysis, prompting further exploration of palopegteriparatide in the preservation of renal function. The current post hoc analysis evaluated the impact of palopegteriparatide treatment on renal function in adults with hypoparathyroidism through Week 104; as with prior analysis, changes in renal function were assessed using eGFR. At Week 104, 93% (76/82) of participants remained in the open-label extension. Of those, 82% had albumin-adjusted serum calcium levels in the normal range (8.3-10.6 mg/dL), 97% were independent from conventional therapy (≤600 mg/d of elemental calcium and no active vitamin D). Mean (SD) serum phosphate (3.5 (0.7) mg/dL) and albumin-adjusted calcium × phosphate product (30.7(5.1) mg2/dL2) levels were also within normal ranges. Palopegteriparatide treatment resulted in a mean (SD) increase in eGFR of 8.9 (11.0) mL/min/1.73m2 (p < .0001) from baseline to Week 52, which was sustained through Week 104, where it was 77.8 (14.8) mL/min/1.73 m2 with a mean (SD) change from baseline of 9.0 (10.3) mL/min/1.73 m2 (p < .0001). By Week 104, 45% and 34% of participants had an increase in eGFR of ≥5 mL/min/1.73 m2 and ≥10 mL/min/1.73 m2, respectively. Palopegteriparatide treatment normalized mean (SD) 24-h urine calcium within 26 wk and maintained levels below 250 mg/d through Week 104 (158.8 (90.5) mg/24 h). Most treatment-emergent adverse events were mild or moderate; no new safety signals or cases of treatment-related nephrolithiasis were reported. These findings demonstrate sustained renal safety of palopegteriparatide and suggest that PTH replacement therapy with palopegteriparatide preserves and may improve renal function in adults with chronic hypoparathyroidism after 104 wk of treatment.

Indexed as

HypoparathyroidismKidneyAdultCalciumChronic DiseaseFemaleFibroblast Growth Factor-23Fibroblast Growth FactorsGlomerular Filtration RateHumansKidney Function TestsMaleMiddle AgedParathyroid HormonePeptidesCalciumFibroblast Growth Factor-23Fibroblast Growth FactorsPalopegteriparatideParathyroid HormonePeptidesclinical trialshormone replacement/receptor modulatorsparathyroid-related disordersPTH/Vit D/FGF23systems biology - bone interactors

Identifiers

PMID42166177
PMCPMC13525197

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.