NCT07299838

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 23, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 25, 2025

Completed
28 days until next milestone

First Posted

Study publicly available on registry

December 23, 2025

Completed
Last Updated

January 26, 2026

Status Verified

January 1, 2026

Enrollment Period

1.3 years

First QC Date

November 25, 2025

Last Update Submit

January 23, 2026

Conditions

Hypoparathyroidism

Keywords

hypoparathyroidismpalopegteriparatidecalciumphosphatevitamin DrhPTH(1-84)real -word-data

Outcome Measures

Primary Outcomes (1)

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

    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.

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

Secondary Outcomes (5)

  • Clinical and Biochemical Outcomes Following Palopegteriparatide Treatment in HypoPT Patients

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

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

    baseline to last visit within the 14 months of treatmemt

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

    baseline to last visit within the 14 months of treatmemt

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

    baseline to last visit within the 14 months of treatmemt

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

    baseline to last visit within the 14 months of treatmemt

Study Arms (1)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients (≥18 years) with a confirmed diagnosis of chronic hypoparathyroidism (HypoPT) of at least 12 months' duration who initiated palopegteriparatide (TransCon PTH)

You may qualify if:

  • Adult patients (≥18 years) with a confirmed diagnosis of chronic hypoparathyroidism (HypoPT) of at least 12 months' duration who initiated palopegteriparatide (TransCon PTH)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laiko General Hospital

Athens, Attica, 11527, Greece

Location

Related Publications (10)

  • Khan 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: 36161671RESULT

  • Khan 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: 36054621RESULT

  • Rejnmark L, Gosmanova EO, Khan AA, Makita N, Imanishi Y, Takeuchi Y, Sprague S, Shoback DM, Kohlmeier L, Rubin MR, Palermo A, Schwarz P, Gagnon C, Tsourdi E, Zhao C, Makara MA, Ominsky MS, Lai B, Ukena J, Sibley CT, Shu AD. Palopegteriparatide Treatment Improves Renal Function in Adults with Chronic Hypoparathyroidism: 1-Year Results from the Phase 3 PaTHway Trial. Adv Ther. 2024 Jun;41(6):2500-2518. doi: 10.1007/s12325-024-02843-8. Epub 2024 Apr 30.

    PMID: 38691316RESULT

  • Siggelkow H, Peschke KA, Tsourdi E, Hofbauer LC, Berr CM, Hahner S, Lottspeich C, Schmidmaier R, Blaschke M. Switch From rhPTH1-84 to TransCon PTH With Individual Dose Adjustment in Adult Hypoparathyroidism-4-Week Results. J Endocr Soc. 2025 Jun 30;9(9):bvaf113. doi: 10.1210/jendso/bvaf113. eCollection 2025 Sep.

    PMID: 40709359RESULT

  • Graham T, Shoback DM, Abbott L, Lubitz S, Edelson G, Haider A, Ing SW, Rothman MS, Cusano NE, Zhao C, Ukena J, Schneider M, Sibley CT, Rubin MR. Early U.S. Real-World Treatment Patterns and Outcomes in Palopegteriparatide Treatment for Patients With Hypoparathyroidism. Endocr Pract. 2025 Dec;31(12):1568-1575. doi: 10.1016/j.eprac.2025.08.008. Epub 2025 Aug 20.

    PMID: 40846304RESULT

  • Karpf DB, Pihl S, Mourya S, Mortensen E, Kovoor E, Markova D, Leff JA. A Randomized Double-Blind Placebo-Controlled First-In-Human Phase 1 Trial of TransCon PTH in Healthy Adults. J Bone Miner Res. 2020 Aug;35(8):1430-1440. doi: 10.1002/jbmr.4016. Epub 2020 Apr 16.

    PMID: 32212275RESULT

  • Khan AA, Rubin MR, Schwarz P, Vokes T, Shoback DM, Gagnon C, Palermo A, Marcocci C, Clarke BL, Abbott LG, Hofbauer LC, Kohlmeier L, Pihl S, An X, Eng WF, Smith AR, Ukena J, Sibley CT, Shu AD, Rejnmark L. Efficacy and Safety of Parathyroid Hormone Replacement With TransCon PTH in Hypoparathyroidism: 26-Week Results From the Phase 3 PaTHway Trial. J Bone Miner Res. 2023 Jan;38(1):14-25. doi: 10.1002/jbmr.4726. Epub 2022 Nov 12.

    PMID: 36271471RESULT

  • Khan 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: 40680836RESULT

  • Pasieka 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: 36153665RESULT

  • Kassi 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: 40576884RESULT

Related Links

MeSH Terms

Conditions

Hypoparathyroidism

Condition Hierarchy (Ancestors)

Parathyroid DiseasesEndocrine System Diseases

Study Officials

  • Eva Kassi, M.D

    Medical School, National and Kapodistrian University of Athens, LAIKO University Hospital of Athens

    PRINCIPAL INVESTIGATOR

  • Symeon Tournis, M.D

    Laboratory for Research of the Musculoskeletal System "Th. Garofalidis", Medical School, National and Kapodistrian University of Athens, KAT Hospital, 10 Athinas Str, Kifissia, Athens,

    STUDY DIRECTOR

  • Fotini Adamidou, M.D

    Department of Endocrinology and Diabetes, Hippokratio General Hospital, Thessaloniki, Greece.

    STUDY DIRECTOR

  • Zoe Efstathiadou, MD

    Department of Endocrinology and Diabetes, Hippokratio General Hospital, Thessaloniki, Greece.

    STUDY DIRECTOR

  • Andromachi Vryonidou, M.D

    Department of Endocrinology and Diabetes, Hellenic Red Cross Hospital, Athens, Greece.

    STUDY DIRECTOR

  • Polyzois Makras, M.D

    Department of Endocrinology and Diabetes, Department of Medical Research, 251 Hellenic Air Force General Hospital, Athens, Greece

    STUDY DIRECTOR

  • Dimos Florakis, M.D.

    Department of Endocrinology, Metropolitan General Hospital, Athens, Greece.

    STUDY DIRECTOR

  • Alexandra Chrisoulidou, M.D

    Department of Endocrinology, Theagenio Cancer Hospital, 54639 Thessaloniki, Greece.

    STUDY DIRECTOR

  • Theodora Stratigou, M.D

    Department of Endocrinology and First Department of Internal Medicine, 'Evangelismos' General Hospital of Athens, Athens, Greece.

    STUDY DIRECTOR

  • Irene Giagourta, M.D

    Unit of Endocrinology, and Diabetes Center, 'G. Gennimatas' General Hospital of Athens, Athens, Greece.

    STUDY DIRECTOR

  • Maria Yavropoulou, M.D

    Medical School, National and Kapodistrian University of Athens, LAIKO University Hospital of Athens

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Endocrinology Consultant

Study Record Dates

First Submitted

November 25, 2025

First Posted

December 23, 2025

Study Start

June 1, 2024

Primary Completion

September 30, 2025

Study Completion

October 23, 2025

Last Updated

January 26, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Due to participant privacy concerns and institutional policies, individual participant data will not be shared outside the research team

Locations

GR(1)