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.
Injection of Teriparatide to Prevent Hypocalcemia After Parathyroidectomy in Dialysis Patients (TeriCa).
Status
Completed
Phase
Phase 3
Enrollment
20
Locations
1
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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.
Full 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.
Interventions
Treatment arms and agents.
Timeline
From registration to results.
First posted
Feb 11, 2021
Study start
Mar 1, 2021
Primary completion
Feb 16, 2022
Study completion
Feb 16, 2022
Results posted
Not reported
Registry updated
Nov 10, 2022
Outcomes
What the study measures.
Primary outcomes
Total serum calcium level
Time frame · Day 1,2,3,4,5
Secondary outcomes
Parathyroid hormone level
Time frame · Day 1, 2, 3, 4, 5
Serum phosphorus level
Time frame · Day 1, 2, 3, 4, 5
Serum total alkaline phosphatase level
Time frame · Day 1, 2, 3, 4, 5
Total serum calcium level
Time frame · Day 2, 3, 4, 5
Ionized serum calcium level
Time frame · Day 1, 2, 3, 4, 5
Serious adverse events (major cardiovascular events, fractures, arrhythmia episodes, death)
Time frame · up to 1 week
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- 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).
Study locations
1 registered sites.
Russia. Showing up to 24 locations stored in the fast local snapshot.
Saint-Petersburg State University Hospital
Saint Petersburg, Russia
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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Related PeptideStat pages
Put the record in context.
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