Calcium Replacement Therapy in Postoperative Hypoparathyroidism
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Calcium carbonate 1250 mg (500 mg elemental calcium) twice a day, Calcium carbonate 1250 mg (500 mg elemental calcium) 4 times a day.
- Who it may be relevant to
- Registry conditions: Post-Thyroidectomy Hypoparathyroidism Treatment. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Estonia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Pilot Study of Calcium Replacement Therapy in Postoperative Hypoparathyroidism
Overview
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
- Drug Calcium 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) - Drug Calcium 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.
Primary outcome measures
- Occurence of symptomatic hypoparathyroidism [Time frame: 2 weeks]
Secondary outcome measures (3)
- Serum calcium levels at 2 week follow-up [Time frame: 2 weeks]
- Duration and permanence of hypoparathyroidism [Time frame: Up to 12 months postoperatively]
- Serum parathyroid hormone (PTH) levels at 2 week follow-up [Time frame: 2 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Estonia · 2 centers
- East Tallinn Central Hospital — Tallinn
- Tartu University Hospital — Tartu
Identifiers
NCT: NCT07577570 · TartuUH-ETCH_403/T-13_2