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

What Was Tested

In this phase 3 trial, researchers set out to test Teriparatide for hyperparathyroidism.

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.

It had two arms (groups): Teriparatide group (11 patients) (experimental) and Control group (9 patients) (no intervention).

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.

The registry classes the interventions as drug.

More on the Plan

Postoperative hypocalcemia is a common complication after parathyroidectomy (PTx) for secondary hyperparathyroidism in dialysis-dependent patients.

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

Who Took Part

Enrollment: 20 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Age \> 18 years;. Patients with end-stage renal disease (ESRD) receiving hemodialysis or peritoneal dialysis treatment \> 3 months prior surgery;. 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;. Performed total parathyroidectomy with autotransplantation of the parathyroid tissue.

The full record lists 4 inclusion and 6 exclusion criteria; among the exclusions: emergency surgery;; primary hyperparathyroidism as a cause of esrd;; scheduled (before surgery) blood transfusion;.

How the Study Was Run

Design: randomized, parallel-group and open-label.

Because people in this Teriparatide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the hyperparathyroidism participants stayed in one arm throughout.

Being open-label, the Teriparatide study did not mask who received what.

It started in 2021-03-01 with completion listed for 2022-02-16.

It ran at 1 site in Russia.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Total serum calcium level (time frame: Day 1,2,3,4,5).

It also tracked 6 secondary outcomes, for example Parathyroid hormone level, Serum phosphorus level, Serum total alkaline phosphatase level, Total serum calcium level and Ionized serum calcium level.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Teriparatide in 20 people with hyperparathyroidism.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Teriparatide compound page, Hyperparathyroidism research.