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Trial · Observational

CompletedPhase not statedRegistry data

Palopegteriparatide in Chronic Hypoparathyroidism

Short name PaTHreal

NCTNCT07299838 (opens ClinicalTrials.gov in a new tab)Other id257
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase not stated
Enrollment
90 participants (actual)
Sponsor
National and Kapodistrian University of Athens · Other
Design
Not stated
Countries
1 country

Greece

Start
1 Jun 2024
Primary completion
30 Sept 2025
Completion
23 Oct 2025
First posted
23 Dec 2025
Last update posted
26 Jan 2026
Conditions
Hypoparathyroidism

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202420252026
  1. Ph –

    PaTHreal

    NCT07299838

    1 Jun 2024 to 23 Oct 2025

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This is a multicenter, prospective cohort study conducted across 9 tertiary and university hospitals in the rural area of Athens, which investigates the clinical and biochemical effects of palopegteriparatide (TransCon PTH) in adult patients with chronic hypoparathyroidism (≥12 months). Eligible participants included those transitioning from conventional therapy (activated vitamin D analogs and oral calcium) and those previously treated with rhPTH(1-84). The primary objective was to assess the time to independence from activated vitamin D and calcium supplementation. Secondary objectives included changes in biochemical parameters, incidence of clinically significant hypo- and hypercalcemia during the titration period , and reduction in daily pill burden. Patients received individualized doses of palopegteriparatide with follow-up visits at regular intervals, and safety was monitored throughout the study according to standard clinical practice.

Arms1

  • Other

    Chronic hypoparathyroidism patients treated with palopegteriparatide

    Adult patients with chronic hypoparathyroidism (≥12 months) initiating treatment with palopegteriparatide (TransCon PTH). The cohort includes patients transitioning from conventional therapy (activated vitamin D and calcium supplementation) as well as patients previously treated with rhPTH(1-84). Palopegteriparatide doses were individually titrated based on serum calcium levels and clinical response. Concomitant calcium and activated vitamin D supplementation were adjusted or discontinued according to the treating physician's discretion.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Time to achievement of independence from activated vitamin D and oral calcium supplementation

    Time frame · From June 2024 (commercial availability of palopegteriparatide in Greece) through September 2025 (end of observation period).

    Registry description

    The primary endpoint was the time to achievement of independence from activated vitamin D and oral calcium supplementation following initiation of palopegteriparatide. Independence was defined as the absence of any activated vitamin D or calcium supplementation for at least four consecutive weeks, without any increase in the palopegteriparatide dose during that period.

Secondary outcomes(5)

  1. Clinical and Biochemical Outcomes Following Palopegteriparatide Treatment in HypoPT Patients

    Time frame · From June 2024 (commercial availability of palopegteriparatide in Greece) through September 2025 (end of observation period).

    Registry description

    I. The proportion of patients achieving independence from activated vitamin D and calcium within the 14-month observation period.

  2. II. To asses changes in albumin corrected calcium levels between baseline and last visit

    Time frame · baseline to last visit within the 14 months of treatmemt

  3. II. To asses changes in phosphate levels between baseline and last visit

    Time frame · baseline to last visit within the 14 months of treatmemt

  4. II. To asses changes in calcium 24 hour urine levels between baseline and last visit

    Time frame · baseline to last visit within the 14 months of treatmemt

  5. II. To asses changes in magnesium levels between baseline and last visit

    Time frame · baseline to last visit within the 14 months of treatmemt

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies6

Studies that cite this trial.

Studies with results

6 studies on this page

Indexing hint: Observational study · 2026

8 results

Real-world data for effectiveness and safety of palopegteriparatide in patients with chronic hypoparathyroidism: the PaTH REAL study.

Yavropoulou et al. 2026European journal of endocrinology

PMID 42656047DOI 10.1093/ejendo/lvag145PUB-42656047

Full text at the publisher8 results
Publisher pageSee results (8)

PubMed tag: none · 2025

6 results

Switch From rhPTH1-84 to TransCon PTH With Individual Dose Adjustment in Adult Hypoparathyroidism-4-Week Results.

Siggelkow et al. 2025Journal of the Endocrine Societycited by 1

PMID 40709359PMC12287600DOI 10.1210/jendso/bvaf113PUB-40709359

CC BY6 results
Download PDFSee results (6)

PubMed tag: none · 2025

4 results

Early U.S. Real-World Treatment Patterns and Outcomes in Palopegteriparatide Treatment for Patients With Hypoparathyroidism.

Graham et al. 2025Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologistscited by 1

PMID 40846304DOI 10.1016/j.eprac.2025.08.008PUB-40846304

Full text at the publisher4 results
Publisher pageSee results (4)

Indexing hint: Randomized controlled trial · 2024

8 results

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

Rejnmark et al. 2024Advances in therapycited by 33

PMID 38691316PMC11133178DOI 10.1007/s12325-024-02843-8PUB-38691316

Free to read · publisher termsCC BY-NC8 results
Read at sourceSee results (8)

Indexing hint: Randomized controlled trial · 2023

7 results

Efficacy and Safety of Parathyroid Hormone Replacement With TransCon PTH in Hypoparathyroidism: 26-Week Results From the Phase 3 PaTHway Trial.

Khan et al. 2023Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Researchcited by 81

PMID 36271471PMC10099823DOI 10.1002/jbmr.4726PUB-36271471

CC BY7 results
Download PDFSee results (7)

Indexing hint: Randomized controlled trial · 2020

14 results

A Randomized Double-Blind Placebo-Controlled First-In-Human Phase 1 Trial of TransCon PTH in Healthy Adults.

Karpf et al. 2020Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Researchcited by 46

PMID 32212275PMC9328939DOI 10.1002/jbmr.4016PUB-32212275

CC BY14 results
Download PDFSee results (14)

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • ResultKhan AA, Guyatt G, Ali DS, Bilezikian JP, Collins MT, Dandurand K, Mannstadt M, Murphy D, M'Hiri I, Rubin MR, Sanders R, Shrayyef M, Siggelkow H, Tabacco G, Tay YD, Van Uum S, Vokes T, Winer KK, Yao L, Rejnmark L. Management of Hypoparathyroidism. J Bone Miner Res. 2022 Dec;37(12):2663-2677. doi: 10.1002/jbmr.4716. Epub 2022 Oct 31. PMID 36161671
  • ResultKhan AA, Bilezikian JP, Brandi ML, Clarke BL, Gittoes NJ, Pasieka JL, Rejnmark L, Shoback DM, Potts JT, Guyatt GH, Mannstadt M. Evaluation and Management of Hypoparathyroidism Summary Statement and Guidelines from the Second International Workshop. J Bone Miner Res. 2022 Dec;37(12):2568-2585. doi: 10.1002/jbmr.4691. Epub 2022 Nov 14. PMID 36054621
  • ResultKhan S, Khan AA. Chronic Hypoparathyroidism-Current and Emerging Therapies. Endocr Pract. 2025 Nov;31(11):1478-1487. doi: 10.1016/j.eprac.2025.07.011. Epub 2025 Jul 16. PMID 40680836
  • ResultPasieka JL, Wentworth K, Yeo CT, Cremers S, Dempster D, Fukumoto S, Goswami R, Houillier P, Levine MA, Pasternak JD, Perrier ND, Sitges-Serra A, Shoback DM. Etiology and Pathophysiology of Hypoparathyroidism: A Narrative Review. J Bone Miner Res. 2022 Dec;37(12):2586-2601. doi: 10.1002/jbmr.4714. Epub 2022 Nov 23. PMID 36153665
  • ResultKassi E, Adamidou F, Yavropoulou MP, Anastasilakis AD, Makras P, Vryonidou A, Tournis S. Diagnosis and management of hypoparathyroidism: recommendations of the working group of the Bone Section of the Hellenic Endocrine Society. Hormones (Athens). 2025 Dec;24(4):913-922. doi: 10.1007/s42000-025-00693-9. Epub 2025 Jun 27. PMID 40576884

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Adult patients (≥18 years) with a confirmed diagnosis of chronic hypoparathyroidism (HypoPT) of at least 12 months' duration who initiated palopegteriparatide (TransCon PTH) Exclusion Criteria: * i) transient postsurgical HypoPT ii) severe renal impairment (eGFR \< 30 mL/min/1.73 m²) iii) active malignancy iv) Individuals with impaired responsiveness to PTH (pseudohypoparathyroidism) or any disease that might affect calcium metabolism, phosphate homeostasis, or PTH levels other than hypoparathyroidism v) other drugs known to influence calcium and bone metabolism (except for activated vitamin D analogs and elemental calcium) such as osteoporosis therapies or glucocorticoids other than as replacement therapy.

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