NCT04750460

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Saint Petersburg State University, Russia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-03-01
• Primary completion: 2022-02-16
• Completion: 2022-02-16
• First posted: 2021-02-11
• Last updated: 2022-11-10

Locations

1 site across 1 country: Russia