Lower- versus higher-dose calcium replacement after thyroid removal
Official title: A Pilot Study of Calcium Replacement Therapy in Postoperative Hypoparathyroidism
Run by Tartu University Hospital · NCT07577570 · Data updated 2026-11-12
This will test whether a lower-dose calcium plan works as well as a higher-dose plan to prevent symptoms of low parathyroid function in adults after thyroid removal.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Tartu University Hospital Academic / other |
| Locations | 2 sites (Tallinn, Other and 1 other locations) |
| Status | Recruiting |
| Started | November 18, 2025 |
| Main results expected | October 2027 |
| Study ends | December 2028 |
| Registry record updated | May 11, 2026 |
| Trial ID | NCT07577570 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (age 18+) undergoing surgery involving both thyroid lobes who have low PTH on the first postoperative day but not so low as to require calcitriol (PTH above the protocol cutoff), with adequate kidney function and not already taking calcium/vitamin D supplements, are ideal candidates.
✕Probably not a fit
Patients with very low PTH requiring calcitriol, those already on calcium or vitamin D for osteoporosis, those with severe renal insufficiency (eGFR less than 30), or those undergoing combined parathyroid surgery are unlikely to benefit from the lower-dose approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults who develop low parathyroid hormone (PTH) levels after bilateral thyroid surgery but do not require calcitriol will be randomly assigned to a lower-dose or higher-dose oral calcium carbonate regimen. The lower-dose arm receives 1250 mg calcium carbonate (500 mg elemental calcium) twice daily and the higher-dose arm receives the same dose four times daily. The main comparison is non-inferiority for preventing symptomatic hypoparathyroidism during the first two postoperative weeks, with a scheduled clinic visit at two weeks to review calcium metabolism and adjust treatment if needed. Patients with symptoms earlier will be managed per protocol and dosing can be altered based on follow-up labs and symptoms.
Why it matters
Potential benefit: If successful, patients could avoid higher calcium dosing and its pill burden or side effects while still preventing symptoms after thyroid surgery.
How similar studies have gone: Prior studies and clinical practice have explored varied dosing after thyroidectomy and some data suggest lower doses can suffice, but randomized non-inferiority data comparing these exact regimens are limited.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
East Tallinn Central Hospital
Tallinn, Other, Estonia Recruiting -
Tartu University Hospital
Tartu, Estonia Recruiting
Study contacts
- Study coordinator: Hanna Hollman
- Email: hanna.hollman@ut.ee
- Phone: +37259037517
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.