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Calcium Replacement Therapy in Postoperative Hypoparathyroidism

ConditionPost-Thyroidectomy Hypoparathyroidism Treatment
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTartu University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Calcium carbonate 1250 mg (500 mg elemental calcium) twice a day

    Drug

    One study group takes calcium carbonate 1250 mg (500 mg elemental calcium) twice a day (at lunchtime and in the evening)

  • Calcium carbonate 1250 mg (500 mg elemental calcium) 4 times a day

    Drug

    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.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Lower dose calcium replacementActive comparator 1 intervention
Group B: Higher dose calcium replacementActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Occurence of symptomatic hypoparathyroidism

Occurrence of symptomatic hypoparathyroidism within 14 days postoperatively

Time frame
2 weeks

Secondary outcomes

1

Serum calcium levels at 2 week follow-up

Comparison of serum calcium levels at the 2-week follow-up between lower- and higher-dose calcium replacement groups.

Time frame
2 weeks
2

Duration and permanence of hypoparathyroidism

Assessment of whether postoperative hypoparathyroidism resolves (transient) or persists (permanent) during follow-up.

Time frame
Up to 12 months postoperatively
3

Serum parathyroid hormone (PTH) levels at 2 week follow-up

Comparison of serum parathyroid hormone (PTH) levels at the 2-week follow-up between lower- and higher-dose calcium replacement groups.

Time frame
2 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tartu University Hospital

Lead sponsor

East Tallinn Central Hospital

Collaborator

Source ClinicalTrials.gov
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