Recruiting

NCT Number: NCT07577570

Calcium Replacement Therapy in Postoperative Hypoparathyroidism

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Post-Thyroidectomy Hypoparathyroidism Treatment

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

East Tallinn Central Hospital, Tallinn, Other, Estonia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

Occurence of symptomatic hypoparathyroidism

Time frame: 2 weeks

Occurrence of symptomatic hypoparathyroidism within 14 days postoperatively

Secondary outcomes

Serum calcium levels at 2 week follow-up

Time frame: 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

Time frame: 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

Time frame: 2 weeks

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

Study contacts

Contact information is provided by the study sponsor or research team.

Ceith Nikkolo

CONTACT

+372 53318092

Hanna Hollman

CONTACT

[email protected]

+37259037517

Sponsors and collaborators

Lead sponsor

Tartu University Hospital

Other

Collaborators

East Tallinn Central Hospital

Registry information

Official study title

A Pilot Study of Calcium Replacement Therapy in Postoperative Hypoparathyroidism

Important dates

Study start: 2025
Primary completion: 2027
Study completion: 2028
First posted: May 11, 2026
Registry last updated: May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.