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

• Sponsor: Saint Petersburg State University, Russia (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT04750460
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 4
• Patients Per Site Per Month: 5

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Secondary Hyperparathyroidism; Chronic Kidney Disease-Mineral and Bone Disorder; Dialysis; Hypocalcemia; Hypoparathyroidism	Drug: Teriparatide	Phase 3

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Effect of Teriparatide on the Early Postoperative Hypocalcemia After Parathyroidectomy in Dialysis Patients: a Pilot, Randomized Trial
• Anticipated Study Start Date: Mar 1, 2021
• Anticipated Primary Completion Date: Jul 1, 2021
• Anticipated Study Completion Date: Jul 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Teriparatide group (10 patients) 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; Subcutaneous injections of study drug will be assigned immediately after parathyroidectomy (20 mcg), on the 1st (20 mcg) and 2nd (10 mcg) postoperative day.; Other Names: Forsteo
No Intervention: Control group (10 patients) 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).

Outcome Measures

Primary Outcome Measures

1. Total serum calcium level [Day 1]

Secondary Outcome Measures

1. Parathyroid hormone level [Day 1, 2, 3, 4, 5]

2. Serum phosphorus level [Day 1, 2, 3, 4, 5]

3. Serum total alkaline phosphatase level [Day 1, 2, 3, 4, 5]

4. Total serum calcium level [Day 2, 3, 4, 5]

5. Ionized serum calcium level [Day 1, 2, 3, 4, 5]

6. Serious adverse events (major cardiovascular events, fractures, arrhythmia episodes, death) [up to 1 week]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Saint-Petersburg State University Hospital	Saint Petersburg		Russian Federation	190103

Sponsors and Collaborators

• Saint Petersburg State University, Russia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Novokshonov Konstantin, MD, PHD, Saint Petersburg State University, Russia
• ClinicalTrials.gov Identifier: NCT04750460
• Other Study ID Numbers: TeriCa
• First Posted: Feb 11, 2021
• Last Update Posted: Mar 17, 2021
• Last Verified: Mar 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Novokshonov Konstantin, MD, PHD, Saint Petersburg State University, Russia: Parathyroidectomy; Teriparatide; Parathyroid hormone
• Additional relevant MeSH terms: Bone Diseases; Chronic Kidney Disease-Mineral and Bone Disorder; Kidney Diseases; Renal Insufficiency, Chronic; Hypocalcemia; Hyperparathyroidism; Hyperparathyroidism, Secondary; Hypoparathyroidism; Teriparatide

Study Results

No Results Posted as of Mar 17, 2021