Calcium Replacement Therapy in Postoperative Hypoparathyroidism

NCT07577570 | Recruiting

• 1 other identifier: TartuUH-ETCH_403/T-13_2
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

Post-Thyroidectomy Hypoparathyroidism Treatment

Keywords

thyroidectomy; calcium replacement therapy; postoperative hypoparathyroidism

Outcome Measures

Primary Outcomes (1)

• Occurence of symptomatic hypoparathyroidism

  Occurrence of symptomatic hypoparathyroidism within 14 days postoperatively

  2 weeks

Secondary Outcomes (3)

• Serum calcium levels at 2 week follow-up

  2 weeks

• Duration and permanence of hypoparathyroidism

  Up to 12 months postoperatively

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

  2 weeks

Study Arms (2)

Lower dose calcium replacement

ACTIVE COMPARATOR

calcium carbonate 1250 mg x 2

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

Higher dose calcium replacement

ACTIVE COMPARATOR

calcium carbonate 1250 mg x 4

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

Interventions

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)

Lower dose calcium replacement

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.

Higher dose calcium replacement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Tartu University Hospital: lead
• East Tallinn Central Hospital: collaborator

Study Sites (2)

East Tallinn Central Hospital

Tallinn, Other, 11914, Estonia

RECRUITING

Tartu University Hospital

Tartu, Estonia

RECRUITING

MeSH Terms

Interventions

Calcium Carbonate; Calcium

Intervention Hierarchy (Ancestors)

Calcium Compounds; Inorganic Chemicals; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Minerals; Metals, Alkaline Earth; Elements; Metals; Blood Coagulation Factors; Biological Factors

Central Study Contacts

Hanna Hollman

CONTACT

+37259037517; hanna.hollman@ut.ee

Ceith Nikkolo

CONTACT

+372 53318092

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: general surgeon, PhD

Model Details: 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

Study Record Dates

• First Submitted: April 21, 2026
• First Posted: May 11, 2026
• Study Start: November 18, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: May 11, 2026

Record last verified: 2026-05

Locations

ES (2)