Postoperative Hypoparathyroidism after thyroid surgery.
Conditions
Brief summary
Incidence of chronic postoperative hypoparathyroidism at 6 months post-surgery, defined by persistently low corrected calcium and PTH values in the absence of vitamin D or calcium discontinuation.
Detailed description
Incidence of temporary hypoparathyroidism at 30 days., Differences in replacement therapy needs (alfacalcidol, calcium carbonate, cholecalciferol) at Day 7, Month 1, 3, and 6., Safety/tolerability based on AE/SAE reports., Patient-reported symptoms of hypocalcemia.
Interventions
DRUGThe placebo has the same composition as the investigational medicinal product t r o f o c a r d ® m a x granules for oral solution 2.459
DRUG2 (243mg++) mg/sachet (with the exception of the active substance)
DRUGTROFOCARD® max
Sponsors
Henry Dunant Hospital Center
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of chronic postoperative hypoparathyroidism at 6 months post-surgery, defined by persistently low corrected calcium and PTH values in the absence of vitamin D or calcium discontinuation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of temporary hypoparathyroidism at 30 days., Differences in replacement therapy needs (alfacalcidol, calcium carbonate, cholecalciferol) at Day 7, Month 1, 3, and 6., Safety/tolerability based on AE/SAE reports., Patient-reported symptoms of hypocalcemia. | — |
Countries
Greece
Outcome results
None listed