Effects of Total Thyroid Removal on Parathyroid Function and Quality of Life

NCT07381998 | Enrolling By Invitation DMC

• 1 other identifier: 1-10-72-155-25
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Postoperative hypoparathyroidism (hypoPT) is the most frequent complication after total thyroidectomy (TT). It is caused by impaired parathyroid function, leading to low calcium levels, patient discomfort, reduced quality of life (QoL), and increased healthcare costs. Traditionally, all TT patients undergo routine postoperative blood testing and standard calcium supplementation, despite varying individual risk. This investigator-initiated project aims to improve patient outcomes by using intraoperative parathyroid hormone (ioPTH) measurements to guide postoperative care. The ioPTH decline reflect parathyroid function immediately after surgery and can identify patients at high or low risk of hypoPT. The study is designed as a prospective, randomized controlled trial (RCT) with two arms: Arm A (\<75% ioPTH decrease): Patients randomized to either omission of routine postoperative calcium/PTH blood tests or standard monitoring. Arm B (\>75% ioPTH decrease): Patients randomized to either early high-dose calcium and vitamin D supplementation or standard therapy. Primary outcomes are calcium and PTH levels postoperatively, incidence of hypocalcemia, and healthcare resource use. Secondary outcomes include QoL assessed by validated questionnaires (ThyPro39, SF-36, HPQ27), transient and permanent hypoPT rates, and other surgical complications. By tailoring care to individual risk, the study aims to safely reduce unnecessary blood tests and optimize early treatment for high-risk patients. This approach has the potential to shorten hospital stays, reduce symptoms, improve QoL, and lower costs. The findings may influence clinical guidelines nationally and internationally, supporting more personalized and evidence-based management of TT patients.

Conditions

Quality of Life; Hypoparathyroidism Post-surgical

Outcome Measures

Primary Outcomes (2)

• Plasma ionized calcium (Ca2+) concentration at postoperative week 1 (POD7), by POD1 biochemical testing status

  Comparison of plasma ionized calcium (Ca2+ mmol/L) and parathyroid hormone (PTH pmol/L) after one postoperative week between patients with and without biochemical measurements at post operative day 1 (POD1.)

  2 years

• Plasma ionized calcium (Ca2+ mmol/L) concentration on postoperative day 2 (POD2)

  Comparison of plasma ionized calcium (Ca2+ mmol/L) between groups at postoperative day 2 (POD2).

  1 year

Secondary Outcomes (15)

• Incidence of clinically significant hypocalcemia requiring medical intervention through 12 months

  2 years

• Number of postoperative blood tests through 12 months

  2 years

• Length of index hospital stay after surgery

  2 years

• Change from baseline in Thyroid-Specific Patient-Reported Outcome measure (ThyPRO-39) score through 12 months

  2 years

• Change from baseline in 36-Item Short Form Health Survey (SF-36) score through 12 months

  2 years

Study Arms (4)

<75 % fall in intraoperative parathyroidhormone

NO INTERVENTION

Standard blood test on post operative day 1 including PTH and P-ca

<75 % fall in intraoperative parathyroidhormone experimental

EXPERIMENTAL

Ommit routine blood test on post operative day 1

Diagnostic Test: Ommit routine blood test post operative day 1

>75% fall in intraoperative parathyroidhormone

NO INTERVENTION

Standard treatment

>75% fall in intraoperative parathyroidhormone experimental

EXPERIMENTAL

Start in Unikalk 4 times per day + d-vitamin + alfacalcidol 2 microgram 2 times per day.

Drug: high-dose calcium (400 mg x 4), vitamin D (19 mikg x 4), and active vitamin D supplementation (2 mikg x 2)

Interventions

Ommit routine blood test post operative day 1 DIAGNOSTIC_TEST

Patients are randomized to either clinical monitoring only, without routine postoperative POD1 measurements of Ca2+ and PTH in one group or standard postoperative care, including routine blood tests for Ca2+ and PTH at POD1. All patients will have Ca2+ and PTH measured after the first postoperative week

<75 % fall in intraoperative parathyroidhormone experimental

high-dose calcium (400 mg x 4), vitamin D (19 mikg x 4), and active vitamin D supplementation (2 mikg x 2) DRUG

Standard postoperative treatment includes low-dose calcium (400 mg x 2) and vitamin D (19 mikg x 2) is initiated for all patients. In the intervention group, patients are randomized to standard low-dose (control group) or standard high-dose treatment including immediate postoperative initiation of high-dose calcium (400 mg x 4), vitamin D (19 mikg x 4), and active vitamin D supplementation (2 mikg x 2). In the control group, treatment with active vitamin D is only initiated in case of low PTH (\<1.0 pmol/L) and low Ca2+ (\<1.10 mmol/L).

>75% fall in intraoperative parathyroidhormone experimental

Eligibility Criteria

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

You may qualify if:

• Adult patients (≥18 years) undergoing Total thyroidectomy with intraoperative PTH measurements.

You may not qualify if:

• Malabsorption (intestinal resection or gastric by-pass).
• Renal insufficiency (eGFR\<30 ml/min) or deemed clinically high-risk requiring mandatory biochemical monitoring.
• Hypercalcemia (Ca2+ \> 1.32 mmol/L).
• Previous thyroid or parathyroid operations.

Sponsors & Collaborators

• Aarhus University Hospital: lead

Study Sites (1)

Department of Otorhinolaryngology, Head and Neck Surgery

Aarhus, Central Jutland, 8200, Denmark

Location

MeSH Terms

Interventions

Calcium; Vitamin D

Intervention Hierarchy (Ancestors)

Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals; Blood Coagulation Factors; Biological Factors; Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Lars Rolighed, Professor, PhD, FEBS

  Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, PhD student

Study Record Dates

• First Submitted: January 21, 2026
• First Posted: February 2, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)