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

Saint Petersburg State University, Russia20 enrolled

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Secondary Hyperparathyroidism Chronic Kidney Disease-Mineral and Bone Disorder Dialysis Hypocalcemia Hypoparathyroidism

Interventions

TeriparatideDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Locations (1)

Saint-Petersburg State University Hospital

Saint Petersburg, Russia

Outcomes

Primary Outcomes

Total serum calcium level

Time frame: Day 1,2,3,4,5

Secondary Outcomes

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

Data from ClinicalTrials.gov

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