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NCT Number: NCT04750460

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Saint-Petersburg State University Hospital

Saint Petersburg, 190103, Russia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Other names: Forsteo

Primary outcomes

  1. Total serum calcium level

    Time frame: Day 1,2,3,4,5

Secondary outcomes

  1. Parathyroid hormone level

    Time frame: Day 1, 2, 3, 4, 5

  2. Serum phosphorus level

    Time frame: Day 1, 2, 3, 4, 5

  3. Serum total alkaline phosphatase level

    Time frame: Day 1, 2, 3, 4, 5

  4. Total serum calcium level

    Time frame: Day 2, 3, 4, 5

  5. Ionized serum calcium level

    Time frame: Day 1, 2, 3, 4, 5

  6. Serious adverse events (major cardiovascular events, fractures, arrhythmia episodes, death)

    Time frame: up to 1 week

Sponsors and collaborators

Lead sponsor

Saint Petersburg State University, Russia

Other

Registry information

Official study title

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

Acronym: TeriCa

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 11, 2021
Registry last updated
Nov 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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