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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 16, 2022

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.

Interventions

  • Drug: Teriparatide
    • Subcutaneous injections of study drug will be assigned immediately after parathyroidectomy (20 mcg), on the 1st (20 mcg) and 2nd (10 mcg) postoperative day.

Arms, Groups and Cohorts

  • 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.
  • 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).

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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).

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Saint Petersburg State University, Russia
  • Provider of Information About this Clinical Study
    • Principal Investigator: Novokshonov Konstantin, MD, PHD – Saint Petersburg State University, Russia

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