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

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Drug: Teriparatide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Emergency surgery; Primary hyperparathyroidism as a cause of ESRD; Scheduled (before surgery) blood transfusion; Re-operative surgery; Known allergy to the study drug. Malignant neoplasms of bone tissue (primary or metastatic).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Teriparatide group (11 patients)<br>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. | Drug: Teriparatide<br>* Subcutaneous injections of study drug will be assigned immediately after parathyroidectomy (20 mcg), on the 1st (20 mcg) and 2nd (10 mcg) postoperative day.<br>* Other names: Forsteo;|
| No Intervention: Control group (9 patients)<br>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). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total serum calcium level |  | Day 1,2,3,4,5 | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parathyroidectomy, Teriparatide, Parathyroid hormone