Post-Thyroidectomy Hypoparathyroidism Treatment
Conditions
Keywords
thyroidectomy, calcium replacement therapy, postoperative hypoparathyroidism
Brief summary
The goal of this clinical trial is to evaluate whether a lower-dose calcium replacement therapy is non-inferior to a higher-dose regimen in preventing symptomatic hypoparathyroidism in patients following thyroidectomy. The hypothesis is: • lower-dose calcium replacement therapy is non-inferior to higher-dose therapy in preventing symptomatic hypoparathyroidism during the first two postoperative weeks Researchers will compare patients receiving a lower-dose calcium replacement regimen with those receiving a higher-dose regimen to assess whether the lower dose is not associated with a higher incidence of symptomatic hypoparathyroidism. Patients who develop post-thyroidectomy hypoparathyroidism are divided into groups for calcium replacement therapy. If they are asymptomatic, they will be scheduled for a follow-up visit at two weeks after surgery. During the follow-up visit, calcium metabolism will be evaluated, and treatment adjusted if necessary.
Interventions
DRUGCalcium carbonate 1250 mg (500 mg elemental calcium) twice a day
One study group takes calcium carbonate 1250 mg (500 mg elemental calcium) twice a day (at lunchtime and in the evening)
DRUGCalcium carbonate 1250 mg (500 mg elemental calcium) 4 times a day
The second study group takes 1250 mg of calcium carbonate (500 mg of elemental calcium) four times a day (starting at noon, at approximately 4-hour intervals: at noon, in the early afternoon, in the evening, and before bedtime). This dosage regimen is prescribed because 500 mg of calcium can be absorbed at a time.
Sponsors
Tartu University Hospital
East Tallinn Central Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
This study evaluates different dosing regimens of a widely used calcium preparation; as the drug is already approved and commonly used, a clinical trial phase is not applicable
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients over the age of 18 undergoing surgery involving both lobes of the thyroid gland (thyroidectomy, "near-total" thyroidectomy, subtotal thyroidectomy, and "completed" thyroidectomy) * Based on the first post-operative day analysis, PTH levels are below the normal range (in our hospitals 1.8-7.8 pmol/l), but not so low (below 1.06 pmol/L) as to require calcium replacement therapy with calcitriol (rocaltrol)
Exclusion criteria
* previously diagnosed osteoporosis; the patient is already taking calcium and vitamin D supplements prior to thyroid surgery * renal insufficiency (eGFR \< 30) * patients with concomitant hyperparathyroidism undergoing simultaneous thyroidectomy and parathyroidectomy for a parathyroid adenoma
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurence of symptomatic hypoparathyroidism | 2 weeks | Occurrence of symptomatic hypoparathyroidism within 14 days postoperatively |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum calcium levels at 2 week follow-up | 2 weeks | Comparison of serum calcium levels at the 2-week follow-up between lower- and higher-dose calcium replacement groups. |
| Duration and permanence of hypoparathyroidism | Up to 12 months postoperatively | Assessment of whether postoperative hypoparathyroidism resolves (transient) or persists (permanent) during follow-up. |
| Serum parathyroid hormone (PTH) levels at 2 week follow-up | 2 weeks | Comparison of serum parathyroid hormone (PTH) levels at the 2-week follow-up between lower- and higher-dose calcium replacement groups. |
Countries
Estonia
Contacts
CONTACTHanna Hollman
CONTACTCeith Nikkolo
Outcome results
None listed