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

NCT04750460 | Completed Phase 3

• 1 other identifier: TeriCa
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Parathyroidectomy; Teriparatide; Parathyroid hormone

Outcome Measures

Primary Outcomes (1)

• Total serum calcium level

  Day 1,2,3,4,5

Secondary Outcomes (6)

• 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

Study Arms (2)

Teriparatide group (11 patients)

EXPERIMENTAL

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

Control group (9 patients)

NO INTERVENTION

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).

Interventions

Teriparatide DRUG

Subcutaneous injections of study drug will be assigned immediately after parathyroidectomy (20 mcg), on the 1st (20 mcg) and 2nd (10 mcg) postoperative day.

Also known as: Forsteo

Teriparatide group (11 patients)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Saint Petersburg State University, Russia: lead

Study Sites (1)

Saint-Petersburg State University Hospital

Saint Petersburg, 190103, Russia

Location

MeSH Terms

Conditions

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

Interventions

Teriparatide

Condition Hierarchy (Ancestors)

Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases; Rickets; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Calcium Metabolism Disorders; Vitamin D Deficiency; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Water-Electrolyte Imbalance

Intervention Hierarchy (Ancestors)

Parathyroid Hormone; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PHD

Study Record Dates

• First Submitted: February 2, 2021
• First Posted: February 11, 2021
• Study Start: March 1, 2021
• Primary Completion: February 16, 2022
• Study Completion: February 16, 2022
• Last Updated: November 10, 2022

Record last verified: 2022-11

Locations

RU (1)