Permanent HypoparathyroidismNCT04998968
Quality in Patients With Permanent Hypoparathyroidism After Total Thyroidectomy
An observational study of Permanent Hypoparathyroidism, run by Uppsala University at 1 site in Sweden.
Trial summary
Quality of life study. The study with include all patients operated with total thyroidectomy between 2005-2015 in Uppsala-Örebro healthcare region, Sweden. The study population has been identified in a previous study and includes close to 1700 patients, of which about 200 developed permanent hypoparathyroidism after… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Permanent Hypoparathyroidism
- How many people
- 1,700 participants
- Where
- 1 siteSweden
- Study dates
- 1 Sep 2021to 31 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: The patients are identified through the national quality registry for endocrine surgery, SQRTPA and the Swedish National Patient Register
Who may be able to join
- Total thyroidectomy between 2005-2015 in Uppsala-Orebro healthcare region.
Who cannot join
- Malignancy
- Sternotomy
- Previous thyroid surgery
- Previous or concurrent parathyroidectomy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Quality of Life in Patients With Permanent Hypoparathyroidism After Total Thyroidectomy in a Swedish Population Based Cohort
Quality of life study. The study with include all patients operated with total thyroidectomy between 2005-2015 in Uppsala-Örebro healthcare region, Sweden. The study population has been identified in a previous study and includes close to 1700 patients, of which about 200 developed permanent hypoparathyroidism after surgery.
Quality of Life will be assessed using SF-36 Health Surgery and the outcome for patients with and without permanent hypoparathyroidism will be compared.
- Conditions
- Permanent Hypoparathyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with permanent hypoparathyroidism after total thyroidectomy | Patients with permanent hypoparathyroidism after total thyroidectomy for benign thyroid disease. These patients should be operated between 2005-2015 in Uppsala-Örebro healthcare region. Permanent hypoparathyroidism is defined as treatment with Calcium and/or vitamin D more than 12 months after surgery. | |
| Patients without permanent hypoparathyroidism after total thyroidectomy | Patients without permanent hypoparathyroidism after total thyroidectomy for benign thyroid disease. These patients should be operated between 2005-2015 in Uppsala-Örebro healthcare region. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life using SF-36 short form
The SF-36 yields eight scale scores and two summary scores, the physical component summary (PCS) and mental component summary (MCS). Scoring PCS and MCS involves three steps: 1) standardization of the scales (z-scores) 2) aggregation of score scales and 3) transformation of summary scores (t-scores). For each domain (PCS and MCS) the mean score is 50 with a standard deviation of 10. Higher scores indicates better quality of life (score range 0-100)
Measured: 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2021
- Study start1 Sep 2021 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion31 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Permanent 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
- 1,700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olov Norlén, MD, PhD, Principal investigator, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04998968
- Sponsor's protocol ID
- 2021-01997
- Status last verified
- Aug 2021
- First submitted
- 9 Aug 2021
- Last updated
- 25 Aug 2021
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life in Patients With Permanent Hypoparathyroidism After Total Thyroidectomy in a Swedish Population Based Cohort
- ClinicalTrials.gov ID
- NCT04998968
- Acronym / sponsor ID
- 2021-01997
- Conditions
- Permanent Hypoparathyroidism
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,700 participants (estimated)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 May 2022 (estimated)
- First posted
- 10 Aug 2021 (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.
Quality of life study. The study with include all patients operated with total thyroidectomy between 2005-2015 in Uppsala-Örebro healthcare region, Sweden. The study population has been identified in a previous study and includes close to 1700 patients, of which about 200 developed permanent hypoparathyroidism after surgery.
Quality of Life will be assessed using SF-36 Health Surgery and the outcome for patients with and without permanent hypoparathyroidism will be compared.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with permanent hypoparathyroidism after total thyroidectomy | – | –Patients with permanent hypoparathyroidism after total thyroidectomy for benign thyroid disease. These patients should be operated between 2005-2015 in Uppsala-Örebro healthcare region. Permanent hypoparathyroidism is defined as treatment with Calcium and/or vitamin D more than 12 months after surgery. |
| Patients without permanent hypoparathyroidism after total thyroidectomy | – | –Patients without permanent hypoparathyroidism after total thyroidectomy for benign thyroid disease. These patients should be operated between 2005-2015 in Uppsala-Örebro healthcare region. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The patients are identified through the national quality registry for endocrine surgery, SQRTPA and the Swedish National Patient Register
Key inclusion criteria (1 listed)
- Total thyroidectomy between 2005-2015 in Uppsala-Orebro healthcare region.
Key exclusion criteria (4 listed)
- Malignancy
- Sternotomy
- Previous thyroid surgery
- Previous or concurrent parathyroidectomy
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
Quality of Life using SF-36 short form
Time frame: 2021
The SF-36 yields eight scale scores and two summary scores, the physical component summary (PCS) and mental component summary (MCS). Scoring PCS and MCS involves three steps: 1) standardization of the scales (z-scores) 2) aggregation of score scales and 3) transformation of summary scores (t-scores). For each domain (PCS and MCS) the mean score is 50 with a standard deviation of 10. Higher scores indicates better quality of life (score range 0-100)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2021.
- Individual participant dataSharing planned: No
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. This study is not recruiting at the moment.
Olov Norlén, MD, PhD principal investigator
Uppsala University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Permanent Hypoparathyroidism, run by Uppsala University at 1 site in Sweden.
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: status not confirmed, as of the sponsor's last update on 25 Aug 2021. 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 Sweden. 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?
Results are not available in the source record.
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?
Quality of Life using SF-36 short form (time frame: 2021). 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 25 Aug 2021.