Hypoparathyroidism Post-surgicalNCT07381998
Effects of Total Thyroid Removal on Parathyroid Function and Quality of Life
A study testing high-dose calcium (400 mg x 4), vitamin D (19 mikg x 4), and active vitamin D supplementation (2 mikg x 2) and Ommit routine blood test post operative day 1 in people with Hypoparathyroidism Post-surgical and Quality of Life, run by Aarhus University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypoparathyroidism Post-surgical, Quality of Life
- What is being tested?
- high-dose calcium (400 mg x 4), vitamin D (19 mikg x 4), and active vitamin D supplementation (2 mikg x 2) and Ommit routine blood test post operative day 1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jan 2026to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (≥18 years) undergoing Total thyroidectomy with intraoperative PTH measurements.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site
Department of Otorhinolaryngology, Head and Neck Surgery
Aarhus, Central Jutland, 8200
About this study
Official title: The Impact of Total Thyroidectomy on Parathyroid Function and Quality of Life
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.
Read more
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
- Hypoparathyroidism Post-surgical, Quality of Life
- Being tested
- high-dose calcium (400 mg x 4), vitamin D (19 mikg x 4), and active vitamin D supplementation (2 mikg x 2), Ommit routine blood test post operative day 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
Ommit routine blood test post operative day 1Diagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| <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 Receives: 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. Receives: Drug: high-dose calcium (400 mg x 4), vitamin D (19 mikg x 4), and active vitamin D supplementation (2 mikg x 2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.)
Measured: 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).
Measured: 1 year
Secondary outcomes (15)
Incidence of clinically significant hypocalcemia requiring medical intervention through 12 months
Proportion of participants with clinically significant hypocalcemia, defined as plasma ionized calcium (Ca2+) < 1.10 mmol/L and/or presence of symptoms of hypocalcemia, necessitating medical intervention (e.g., IV calcium and/or initiation or escalation of oral calcium ± vitamin D). Incidence will be compared between arms.
Measured: 2 years
Number of postoperative blood tests through 12 months
Total number of postoperative blood tests per participant (count), compared between arms.
Measured: 2 years
Length of index hospital stay after surgery
Duration of initial postoperative hospital stay per participant, measured in days (or hours), compared between arms.
Measured: 2 years
Change from baseline in Thyroid-Specific Patient-Reported Outcome measure (ThyPRO-39) score through 12 months
Change from baseline in Thyroid-Specific Patient-Reported Outcome measure (ThyPRO-39) score assessed at baseline and at 1 week, 2 months, 6 months, and 12 months. Scores are transformed to a 0-100 scale (minimum 0, maximum 100); higher scores indicate worse thyroid-related quality of life (more symptoms/impairment).
Measured: 2 years
Change from baseline in 36-Item Short Form Health Survey (SF-36) score through 12 months
Change from baseline in 36-Item Short Form Health Survey (SF-36) domain scores assessed at baseline and at 1 week, 2 months, 6 months, and 12 months. Each domain score ranges from 0 to 100 (minimum 0, maximum 100); higher scores indicate better health status/quality of life.
Measured: 2 years
Change from baseline in Hypoparathyroidism Patient Questionnaire (HPQ-27/HPQ-28) score through 12 months
Change from baseline in Hypoparathyroidism Patient Questionnaire (HPQ-27/HPQ-28) score assessed at baseline and at 1 week, 2 months, 6 months, and 12 months. Scores are transformed to a 0-100 scale (minimum 0, maximum 100); higher scores indicate worse disease control / greater symptom burden
Measured: 2 years
Adverse events frequency through 12 months
Number and proportion of participants experiencing any adverse event, compared between arms.
Measured: 2 years
Incidence of transient hypoparathyroidism through 12 months
Proportion of participants with transient hypoparathyroidism, defined as plasma ionized calcium (Ca2+) < 1.10 mmol/L and/or need for treatment with alfacalcidol, with subsequent resolution (i.e., no longer meeting the definition and not requiring alfacalcidol) within 12 months. Incidence will be compared between arms.
Measured: 2 years
Incidence of permanent hypoparathyroidism at 12 months
Proportion of participants meeting the hypoparathyroidism definition (plasma ionized calcium (Ca2+) < 1.10 mmol/L and/or need for alfacalcidol) that persists at 12 months, with continued need for alfacalcidol beyond 12 months. Incidence will be compared between arms.
Measured: 2 years
Incidence of postoperative bleeding complication through 30 days
Proportion of participants with postoperative bleeding/hematoma requiring intervention (e.g., re-operation), compared between arms.
Measured: 2 years
Incidence of postoperative infection through 30 days
Proportion of participants with postoperative infection requiring antibiotics and/or drainage, compared between arms.
Measured: 2 years
Incidence of nerve injury through 12 months
Proportion of participants with postoperative nerve injury, defined as recurrent laryngeal nerve palsy, assessed based on patient-reported voice function and confirmed by laryngoscopy, compared between arms.
Measured: 2 years
Number of resected parathyroid glands
Number of resected parathyroid glands per participant (count) based on pathology report, compared between arms.
Measured: 2 years
Number of lymph nodes removed
Number of lymph nodes removed per participant (count) based on pathology report, compared between arms.
Measured: 2 years
Thyroid pathology findings
Final thyroid pathology diagnosis based on the postoperative histopathology report, categorized as cancer, goiter, or thyrotoxicosis-related pathology, and compared between arms
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study start1 Jan 2026
- Primary completionJul 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypoparathyroidism Post-surgicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khalil Rafiqi, Aarhus University Hospital
- Investigators
- Lars Rolighed, Professor, PhD, FEBS, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07381998
- Sponsor's protocol ID
- 1-10-72-155-25
- Status last verified
- Jan 2026
- First submitted
- 21 Jan 2026
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Total Thyroidectomy on Parathyroid Function and Quality of Life
- ClinicalTrials.gov ID
- NCT07381998
- Acronym / sponsor ID
- 1-10-72-155-25
- Conditions
- Hypoparathyroidism Post-surgical, Quality of Life
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 2 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| <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 | Diagnostic Test: Ommit routine blood test post operative day 1Ommit routine blood test on post operative day 1 |
| >75% fall in intraoperative parathyroidhormone | No intervention | –Standard treatment |
| >75% fall in intraoperative parathyroidhormone experimental | Experimental | Drug: high-dose calcium (400 mg x 4), vitamin D (19 mikg x 4), and active vitamin D supplementation (2 mikg x 2)Start in Unikalk 4 times per day + d-vitamin + alfacalcidol 2 microgram 2 times per day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients (≥18 years) undergoing Total thyroidectomy with intraoperative PTH measurements.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| high-dose calcium (400 mg x 4), vitamin D (19 mikg x 4), and active vitamin D supplementation (2 mikg x 2)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). | Drug | >75% fall in intraoperative parathyroidhormone experimental |
| Ommit routine blood test post operative day 1Patients 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 | Diagnostic test | <75 % fall in intraoperative parathyroidhormone experimental |
Primary outcome
Plasma ionized calcium (Ca2+) concentration at postoperative week 1 (POD7), by POD1 biochemical testing status
Time frame: 2 years
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.)
Plasma ionized calcium (Ca2+ mmol/L) concentration on postoperative day 2 (POD2)
Time frame: 1 year
Comparison of plasma ionized calcium (Ca2+ mmol/L) between groups at postoperative day 2 (POD2).
15 secondary outcomes
Incidence of clinically significant hypocalcemia requiring medical intervention through 12 months
Time frame: 2 years
Number of postoperative blood tests through 12 months
Time frame: 2 years
Length of index hospital stay after surgery
Time frame: 2 years
Change from baseline in Thyroid-Specific Patient-Reported Outcome measure (ThyPRO-39) score through 12 months
Time frame: 2 years
Change from baseline in 36-Item Short Form Health Survey (SF-36) score through 12 months
Time frame: 2 years
Change from baseline in Hypoparathyroidism Patient Questionnaire (HPQ-27/HPQ-28) score through 12 months
Time frame: 2 years
Adverse events frequency through 12 months
Time frame: 2 years
Incidence of transient hypoparathyroidism through 12 months
Time frame: 2 years
Incidence of permanent hypoparathyroidism at 12 months
Time frame: 2 years
Incidence of postoperative bleeding complication through 30 days
Time frame: 2 years
Incidence of postoperative infection through 30 days
Time frame: 2 years
Incidence of nerve injury through 12 months
Time frame: 2 years
Number of resected parathyroid glands
Time frame: 2 years
Number of lymph nodes removed
Time frame: 2 years
Thyroid pathology findings
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lars Rolighed, Professor, PhD, FEBS principal investigator
Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high-dose calcium (400 mg x 4), vitamin D (19 mikg x 4), and active vitamin D supplementation (2 mikg x 2) and Ommit routine blood test post operative day 1 in people with Hypoparathyroidism Post-surgical and Quality of Life, run by Aarhus University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma ionized calcium (Ca2+) concentration at postoperative week 1 (POD7), by POD1 biochemical testing status (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2026.