Palopegteriparatide in Chronic Hypoparathyroidism

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.

Conditions

• Hypoparathyroidism

Sponsors & Collaborators

• G.Gennimatas General Hospital

  collaborator OTHER

• Alexandra Hospital, Athens, Greece

  collaborator OTHER

• Theagenio Cancer Hospital

  collaborator OTHER_GOV

• 251 Hellenic Air Force & VA General Hospital

  collaborator OTHER

• Laikο General Hospital, Athens

  collaborator OTHER

• KAT Hospital of Athens

  collaborator UNKNOWN

• Hellenic Red Cross Hospital

  collaborator OTHER

• Hippocration General Hospital

  collaborator OTHER

• Evaggelismos Hospital, Greece

  collaborator UNKNOWN

• National and Kapodistrian University of Athens

  lead OTHER

Principal Investigators

• Eva Kassi, M.D · Medical School, National and Kapodistrian University of Athens, LAIKO University Hospital of Athens

• 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,

• Fotini Adamidou, M.D · Department of Endocrinology and Diabetes, Hippokratio General Hospital, Thessaloniki, Greece.

• Zoe Efstathiadou, MD · Department of Endocrinology and Diabetes, Hippokratio General Hospital, Thessaloniki, Greece.

• Andromachi Vryonidou, M.D · Department of Endocrinology and Diabetes, Hellenic Red Cross Hospital, Athens, Greece.

• Polyzois Makras, M.D · Department of Endocrinology and Diabetes, Department of Medical Research, 251 Hellenic Air Force General Hospital, Athens, Greece

• Dimos Florakis, M.D. · Department of Endocrinology, Metropolitan General Hospital, Athens, Greece.

• Alexandra Chrisoulidou, M.D · Department of Endocrinology, Theagenio Cancer Hospital, 54639 Thessaloniki, Greece.

• Theodora Stratigou, M.D · Department of Endocrinology and First Department of Internal Medicine, 'Evangelismos' General Hospital of Athens, Athens, Greece.

• Irene Giagourta, M.D · Unit of Endocrinology, and Diabetes Center, 'G. Gennimatas' General Hospital of Athens, Athens, Greece.

• Maria Yavropoulou, M.D · Medical School, National and Kapodistrian University of Athens, LAIKO University Hospital of Athens

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-06-01

Primary Completion

2025-09-30

Completion

2025-10-23

Countries

• Greece

Study Locations