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

Saint Petersburg State University, Russia

Status and phase: Completed; Phase 3

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

Treatments: Drug: Teriparatide

Study type: Interventional

Funder types: Other

Identifiers

NCT04750460

TeriCa

Details and patient eligibility

About

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 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Teriparatide group (11 patients)

Experimental group

Description:

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.

Treatment:

Drug: Teriparatide

Control group (9 patients)

No Intervention group

Description:

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).