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

November 7, 2022 updated by: Novokshonov Konstantin, Saint Petersburg State University, Russia

The Effect of Teriparatide on the Early Postoperative Hypocalcemia After Parathyroidectomy in Dialysis Patients: a Pilot, Randomized Trial

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.

Study Overview

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Saint Petersburg, Russian Federation, 190103
        • Saint-Petersburg State University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Teriparatide group (11 patients)
Dialysis-dependent patients underwent total parathyroidectomy with autotransplantation of parathyroid tissue, who will receive subcutaneous injections ot recombinant parathyroid hormone (Teriparatide) after surgery in addition to the standard local protocol for hypocalcemia treatment.
Subcutaneous injections of study drug will be assigned immediately after parathyroidectomy (20 mcg), on the 1st (20 mcg) and 2nd (10 mcg) postoperative day.
Other Names:
  • Forsteo
NO_INTERVENTION: Control group (9 patients)
Dialysis-dependent patients underwent total parathyroidectomy with autotransplantation of parathyroid tissue, receiving standard local protocol for hypocalcemia treatment (2 micrograms of alphacalcidol plus 4 grams of oral calcium daily).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Total serum calcium level
Time Frame: Day 1,2,3,4,5
Day 1,2,3,4,5

Secondary Outcome Measures

Outcome Measure
Time Frame
Parathyroid hormone level
Time Frame: Day 1, 2, 3, 4, 5
Day 1, 2, 3, 4, 5
Serum phosphorus level
Time Frame: Day 1, 2, 3, 4, 5
Day 1, 2, 3, 4, 5
Serum total alkaline phosphatase level
Time Frame: Day 1, 2, 3, 4, 5
Day 1, 2, 3, 4, 5
Total serum calcium level
Time Frame: Day 2, 3, 4, 5
Day 2, 3, 4, 5
Ionized serum calcium level
Time Frame: Day 1, 2, 3, 4, 5
Day 1, 2, 3, 4, 5
Serious adverse events (major cardiovascular events, fractures, arrhythmia episodes, death)
Time Frame: up to 1 week
up to 1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2021

Primary Completion (ACTUAL)

February 16, 2022

Study Completion (ACTUAL)

February 16, 2022

Study Registration Dates

First Submitted

February 2, 2021

First Submitted That Met QC Criteria

February 10, 2021

First Posted (ACTUAL)

February 11, 2021

Study Record Updates

Last Update Posted (ACTUAL)

November 10, 2022

Last Update Submitted That Met QC Criteria

November 7, 2022

Last Verified

November 1, 2022

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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