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

Secondary Hyperparathyroidism Clinical Trial

— TeriCa  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04750460
• Other study ID #: TeriCa
• Status: Completed
• Phase: Phase 3
• Start date: March 1, 2021
• Est. completion date: February 16, 2022

Study information

• Verified date: November 2022
• Source: Saint Petersburg State University, Russia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 16, 2022
• Est. primary completion date: February 16, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Bone Diseases
• Chronic Kidney Disease-Mineral and Bone Disorder
• Dialysis
• Hyperparathyroidism
• Hyperparathyroidism, Secondary
• Hypocalcemia
• Hypoparathyroidism
• Kidney Diseases
• Renal Insufficiency, Chronic
• Secondary Hyperparathyroidism

Intervention

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.

Locations

Country	Name	City	State
Russian Federation	Saint-Petersburg State University Hospital	Saint Petersburg

Sponsors (1)

Lead Sponsor	Collaborator
Saint Petersburg State University, Russia

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total serum calcium level		Day 1,2,3,4,5
Secondary	Parathyroid hormone level		Day 1, 2, 3, 4, 5
Secondary	Serum phosphorus level		Day 1, 2, 3, 4, 5
Secondary	Serum total alkaline phosphatase level		Day 1, 2, 3, 4, 5
Secondary	Total serum calcium level		Day 2, 3, 4, 5
Secondary	Ionized serum calcium level		Day 1, 2, 3, 4, 5
Secondary	Serious adverse events (major cardiovascular events, fractures, arrhythmia episodes, death)		up to 1 week