Chronic Kidney Disease-Mineral and Bone Disorder, Dialysis, Hypocalcemia, Hypoparathyroidism, Secondary Hyperparathyroidism
Conditions
Keywords
Parathyroidectomy, Teriparatide, Parathyroid hormone
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.
Interventions
DRUGTeriparatide
Subcutaneous injections of study drug will be assigned immediately after parathyroidectomy (20 mcg), on the 1st (20 mcg) and 2nd (10 mcg) postoperative day.
Sponsors
Saint Petersburg State University, Russia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total serum calcium level | Day 1,2,3,4,5 |
Secondary
| Measure | Time frame |
|---|---|
| Serum phosphorus level | Day 1, 2, 3, 4, 5 |
| Serum total alkaline phosphatase level | Day 1, 2, 3, 4, 5 |
| Parathyroid hormone 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 |
| Total serum calcium level | Day 2, 3, 4, 5 |
Countries
Russia
Outcome results
None listed