Injection of Teriparatide to Prevent Hypocalcemia After Parathyroidectomy in Dialysis Patients (TeriCa).

Last updated: November 7, 2022
Sponsor: Saint Petersburg State University, Russia
Overall Status: Completed

Phase

3

Condition

Parathyroid Disease

Parathyroid Disorders

Bone Diseases

Treatment

N/A

Clinical Study ID

NCT04750460
TeriCa
  • Ages > 18
  • All Genders

Study Summary

This is a pilot randomized controlled trial aimed to evaluate the effect of teriparatide on the clinical course of hypocalcemia after parathyroidectomy for secondary hyperparathyroidism in dialysis-dependent patients.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age > 18 years;
  2. Patients with end-stage renal disease (ESRD) receiving hemodialysis or peritonealdialysis treatment > 3 months prior surgery;
  3. Severe secondary hyperparathyroidism defined as iPTH level > 800 pg/ml, followed withhypercalcemia and/or hyperphosphatemia; with presence of one or more nodular ordiffuse parathyroid hyperplasia confirmed with CT;
  4. Performed total parathyroidectomy with autotransplantation of the parathyroid tissue.

Exclusion

Exclusion Criteria:

  1. Emergency surgery;
  2. Primary hyperparathyroidism as a cause of ESRD;
  3. Scheduled (before surgery) blood transfusion;
  4. Re-operative surgery;
  5. Known allergy to the study drug.
  6. Malignant neoplasms of bone tissue (primary or metastatic).

Study Design

Total Participants: 20
Study Start date:
March 01, 2021
Estimated Completion Date:
February 16, 2022

Study Description

Postoperative hypocalcemia is a common complication after parathyroidectomy (PTx) for secondary hyperparathyroidism in dialysis-dependent patients. It is known to be associated with significant drop of parathyroid hormone (iPTH) level after surgery. Thus, in the present study we test the hypothesis that reducing iPTH difference before/after PTx with teriparatide injections immediately after surgery may alleviate clinical course of post-PTx hypocalcemia.

This is a feasible study aimed to determine the sample size for further large-scale trial.

Connect with a study center

  • Saint-Petersburg State University Hospital

    Saint Petersburg, 190103
    Russian Federation

    Site Not Available

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