The Effect of Teriparatide on the Early Postoperative Hypocalcemia After Parathyroidectomy in Dialysis Patients: a Pilot, Randomized Trial
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Total serum calcium level
Study Overview
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.
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
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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).
Arms & Interventions
Teriparatide group (11 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.
Intervention: Teriparatide (Drug)
Outcomes
Primary Outcomes
Total serum calcium level
Time Frame: Day 1,2,3,4,5
Secondary Outcomes
- Serum total alkaline phosphatase level(Day 1, 2, 3, 4, 5)
- Ionized serum calcium level(Day 1, 2, 3, 4, 5)
- Serious adverse events (major cardiovascular events, fractures, arrhythmia episodes, death)(up to 1 week)
- Parathyroid hormone level(Day 1, 2, 3, 4, 5)
- Serum phosphorus level(Day 1, 2, 3, 4, 5)
- Total serum calcium level(Day 2, 3, 4, 5)
Investigators
Novokshonov Konstantin
MD, PHD
Saint Petersburg State University, Russia