Post-Surgical HypoparathyroidismNCT07582562
Risk Factors for Hypoparathyroidism Following Thyroidectomy
An observational study of Post-Surgical Hypoparathyroidism, run by Tartu University Hospital at 2 sites in Estonia.
Trial summary
The goal of this observational study is to identify the risk factors for post-thyroidectomy hypoparathyroidism in Estonia and to determine whether the magnesium level plays a significant role in the development of hypoparathyroidism. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-Surgical Hypoparathyroidism
- How many people
- 300 participants
- Where
- 2 sitesEstonia
- Study dates
- 13 Oct 2025to Dec 2028
- Phase
- Observational
- 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
Study population: Patients over the age of 18 at Tartu University Hospital and East Tallinn Central Hospital who are undergoing surgery involving both lobes of the thyroid gland (thyroidectomy, "near-total" thyroidectomy, subtotal thyroidectomy, and "completed" thyroidectomy), and who provide informed consent for this.
Who may be able to join
- patients over the age of 18 undergoing surgery involving both lobes of the thyroid gland (thyroidectomy, "near-total" thyroidectomy, subtotal thyroidectomy, and "completed" thyroidectomy)
- patients who are capable of giving informed consent
Who cannot join
- patients undergoing unilateral thyroid lobectomy only
- patients with concomitant hyperparathyroidism undergoing simultaneous thyroidectomy and parathyroidectomy for a parathyroid adenoma
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Estonia2 sites, 2 recruiting
- Recruiting
East Tallinn Central Hospital
Tallinn
Hanna Hollman, MD, +372 59037517, hanna.hollman@itk.ee
- Recruiting
Tartu University Hospital
Tartu
Ceith Nikkolo, PhD, +372 53319082, ceith.nikkolo@kliinikum.ee
About this study
Official title: A Prospective Study to Assess Risk Factors for Hypoparathyroidism Following Thyroidectomy
The goal of this observational study is to identify the risk factors for post-thyroidectomy hypoparathyroidism in Estonia and to determine whether the magnesium level plays a significant role in the development of hypoparathyroidism. The main questions it aims to answer are:
- How common is post-thyroidectomy hypoparathyroidism in Estonia?
- What are the most significant risk factors for the development of post-thyroidectomy hypoparathyroidism in Estonia?
- Are magnesium levels a risk factor for the development of hypoparathyroidism? Participants will be asked to answer a questionnaire about risk factors. The study collects data on risk factors for hypoparathyroidism following thyroid surgery, including patient questionnaires and comorbidities, pre- and postoperative laboratory tests and surgery-related risk factors.
- Conditions
- Post-Surgical Hypoparathyroidism
- Keywords
- thyroidectomy, hypoparathyroidism, risk factors
- Medical subject headings
- Hypoparathyroidism
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative early hypoparathyroidism
Incidence of early post-thyroidectomy hypoparathyroidism, based on serum PTH levels measured on the morning of the first postoperative day
Measured: first postoperative day
Secondary outcomes (3)
Risk factor assessment of post-thyroidectomy hypoparathyroidism
Risk factors will be categorized as patient-related, disease-related, and surgery-related variables. Risk factors will be assessed using multivariable logistic regression analysis, and results will be reported as odds ratios with 95% confidence intervals.
Patient-related risk factors will be assessed using a structured study-specific questionnaire (including demographic and clinical history variables) and review of electronic medical records. Disease-related risk factors will be assessed using also preoperative laboratory measurements. Surgery-related risk factors will be assessed using standardized operative reports, including variables such as extent of thyroidectomy, identification and preservation of parathyroid glands, and intraoperative findings, recorded according to institutional surgical protocols. Patient- and disease-related variables will be assessed preoperatively, while surgery-related variables will be assessed intraoperatively.
Measured: Preoperative and intraoperative periods
Serum magnesium levels as predictors of post-thyroidectomy hypoparathyroidism
Serum magnesium levels will be measured preoperatively (baseline, prior to surgery) and on postoperative day 1. The predictive value of preoperative and postoperative day 1 serum magnesium levels for early post-thyroidectomy hypoparathyroidism will be assessed using univariable and multivariable logistic regression analysis, with results reported as odds ratios and 95% confidence intervals.
Measured: Preoperative (baseline) and postoperative day 1; hypoparathyroidism assessed within 24 hours postoperatively
Postoperative permanent hypoparathyroidism
Incidence of permanent post-thyroidectomy hypoparathyroidism, defined as persistently low serum PTH levels and/or ongoing requirement for calcium and/or vitamin D supplementation at 12 months after surgery.
Measured: 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study start13 Oct 2025
- Primary completionAug 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 Post-Surgical HypoparathyroidismStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tartu University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- East Tallinn Central Hospital
- Responsible party
- Principal investigator, Ceith Nikkolo, Tartu University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07582562
- Sponsor's protocol ID
- TartuUH-ETCH_403/T-13_1
- Status last verified
- May 2026
- First submitted
- 21 Apr 2026
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study to Assess Risk Factors for Hypoparathyroidism Following Thyroidectomy
- ClinicalTrials.gov ID
- NCT07582562
- Acronym / sponsor ID
- TartuUH-ETCH_403/T-13_1
- Conditions
- Post-Surgical Hypoparathyroidism
- Keywords
- thyroidectomy, hypoparathyroidism, risk factors
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Tartu University HospitalUniversity, hospital or other
- Collaborators
- East Tallinn Central Hospital
- Study start
- 13 Oct 2025 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 13 May 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.
The goal of this observational study is to identify the risk factors for post-thyroidectomy hypoparathyroidism in Estonia and to determine whether the magnesium level plays a significant role in the development of hypoparathyroidism. The main questions it aims to answer are:
- How common is post-thyroidectomy hypoparathyroidism in Estonia?
- What are the most significant risk factors for the development of post-thyroidectomy hypoparathyroidism in Estonia?
- Are magnesium levels a risk factor for the development of hypoparathyroidism? Participants will be asked to answer a questionnaire about risk factors. The study collects data on risk factors for hypoparathyroidism following thyroid surgery, including patient questionnaires and comorbidities, pre- and postoperative laboratory tests and surgery-related risk factors.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients over the age of 18 at Tartu University Hospital and East Tallinn Central Hospital who are undergoing surgery involving both lobes of the thyroid gland (thyroidectomy, "near-total" thyroidectomy, subtotal thyroidectomy, and "completed" thyroidectomy), and who provide informed consent for this.
Key inclusion criteria (2 listed)
- patients over the age of 18 undergoing surgery involving both lobes of the thyroid gland (thyroidectomy, "near-total" thyroidectomy, subtotal thyroidectomy, and "completed" thyroidectomy)
- patients who are capable of giving informed consent
Key exclusion criteria (2 listed)
- patients undergoing unilateral thyroid lobectomy only
- patients with concomitant hyperparathyroidism undergoing simultaneous thyroidectomy and parathyroidectomy for a parathyroid adenoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
postoperative early hypoparathyroidism
Time frame: first postoperative day
Incidence of early post-thyroidectomy hypoparathyroidism, based on serum PTH levels measured on the morning of the first postoperative day
3 secondary outcomes
Risk factor assessment of post-thyroidectomy hypoparathyroidism
Time frame: Preoperative and intraoperative periods
Serum magnesium levels as predictors of post-thyroidectomy hypoparathyroidism
Time frame: Preoperative (baseline) and postoperative day 1; hypoparathyroidism assessed within 24 hours postoperatively
Postoperative permanent hypoparathyroidism
Time frame: 12 months after surgery
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 13 May 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Post-Surgical Hypoparathyroidism
RecruitingObservational study
Postoperative Hypocalcemia After Thyroidectomy
Thyroid Nodule, Thyroid Dysfunction
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Calcium Replacement Therapy in Postoperative Hypoparathyroidism
Post-Thyroidectomy Hypoparathyroidism Treatment
Recruiting
PRESS -PAR: Early Detection and PREvention of Symptomatic postSurgical hypoPARathyroidism After Thyroid Surgery"
Postoperative Hypoparathyroidism, Postsurgical Hypoparathyroidism
RecruitingPhase 1/2
Parathyroid Allotransplant for Treatment of Hypoparathyroidism
Hypoparathyroidism, Hypoparathyroidism Postprocedural
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Comparing PTeye-assisted Versus Conventional Total Thyroidectomy
Hypocalcemia, Parathyroid
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-Surgical Hypoparathyroidism, run by Tartu University Hospital at 2 sites in Estonia.
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 2 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Estonia. 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?
Contact Hanna Hollman, MD (+37259037517, hanna.hollman@ut.ee), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative early hypoparathyroidism (time frame: first postoperative day). 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 13 May 2026.