HypoparathyroidismNCT04053647
Quality of Life Evaluation (SF-36) in Patients With Permanent Hypoparathyroidism After Total Thyroidectomy (Qol-Hypopara)
An observational study of Hypoparathyroidism and Quality of Life, run by Nantes University Hospital at 6 sites in France.
Trial summary
Persistent hypoparathyroidism is an underestimate but major complication of total thyroidectomy. The hypothesis of the investigators is that the mental health is impaired in hypoparathyroid patients compared with thyroidectomized patients without hypoparathyroidism. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypoparathyroidism, Quality of Life
- What is being tested?
- Non-interventional study
- How many people
- 143 participants
- Where
- 6 sitesFrance
- Study dates
- 5 Feb 2020to 24 Jun 2020
- 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
- No healthy volunteers
- Adult, Older adult
Study population: The study population is that of hypoparathyroid patients of the Hypoparathyroidism France combination who have undergone total thyroidectomy and who have agreed to participate in the study. Patients with permanent hypoparathyroidism who were included in the ThyrQol study and in the FOTHYR study will also be solicited. Endocrinologists at the University Hospital of Nantes also have patients with permanent hypoparathyroidism in their patients. The control population consists of patients who had a total thyroidectomy and were included in the ThyrQol study between 2014 and 2018, without sequelary hypoparathyroidism.
Who may be able to join
- Patients operated of total thyroidectomy
- Patients suffering from persistent hypoparathyroidism defined as serum PTH inferior to 15 pg/mL 6 months after the surgery, requiring vitamin-calcic supplementation.
- Age superior to 18
- Answering the survey
Who cannot join
- Pregnancy at the time of the study
- Age inferior to 18 or adult under guardianship
- Patients with vitamino-calcic supplementation without serum PTH measurement
- Cause of hypoparathyroidism other than post-operatory.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
CHU Angers
Angers, 49100
Centre Hospitalier Le Mans
Le Mans, 72037
CHU Limoges
Limoges, 87042
CHU Nancy
Nancy, 54511
CHU Nantes
Nantes, 44000
AP-HP La Pitié Salpétrière
Paris, 75013
About this study
Official title: Quality of Life Evaluation (SF-36) in Patients With Permanent Hypoparathyroidism After Total Thyroidectomy
Persistent hypoparathyroidism is an underestimate but major complication of total thyroidectomy. The hypothesis of the investigators is that the mental health is impaired in hypoparathyroid patients compared with thyroidectomized patients without hypoparathyroidism. The investigators evaluated the quality of life using the SF-36 survey in comparison with a control population of patients thyroidectomized but free from this complication. The voice quality, the cardiovascular risk, the kidney function and the incidence of urinary lithiasis were also evaluated.
Read the detailed description
Persistent hypoparathyroidism is an underestimate but major complication of total thyroidectomy. In this retrospective, observational, multicentre study, the investigators evaluated the quality of life using the SF-36 survey in comparison with a control population of patients thyroidectomized but free from this complication. Patients in six centers in France (Angers, Le Mans, Limoges, Nancy, Nantes, la Pitié-Salpétrière) and in the association "Hypoparathyroïdisme France" were contacted by mail. The primary endpoint was the mental health. The physic and global quality of life scores were assessed as secondary endpoints. Medical and VHI surveys were also send to the patients. The voice quality, the cardiovascular risk, the kidney function and the incidence of urinary lithiasis were also evaluated.
- Conditions
- Hypoparathyroidism, Quality of Life
- Being tested
- Non-interventional study
- Medical subject headings
- Hypoparathyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-interventional studyOther
Non-interventional study
| Study group | Role | What they receive |
|---|---|---|
| Hypoparathyroid patients | Patients with persistent hypoparathyroidism after total thyroidectomy, defined as serum PTH inferior to 15 pg/mL 6 months after surgery and the need of vitamin-calcic supplementation. Receives: Other: Non-interventional study | |
| Control patients, without hypoparathyroidism | Not described Receives: Other: Non-interventional study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mental health
Items from mental quality of life score defined by the SF36 (Short Form 36) survey
Measured: Through study completion, an average of 1 year
Secondary outcomes (6)
Physical quality score
Items from the SF36 (Short Form 36) survey
Measured: Through study completion, an average of 1 year
Global quality of life score
Items from the SF36 (Short Form 36) survey
Measured: Through study completion, an average of 1 year
Voice quality
Items from the VHI (Voice Handicap Index) survey
Measured: Through study completion, an average of 1 year
Renal function quality
Serum creatinine and clearance dosage
Measured: Through study completion, an average of 1 year
Presence of urinary lithiasis
Serum creatinine and clearance dosage
Measured: Through study completion, an average of 1 year
Presence of cardiovascular complications
Defined as ischemic cardiopathy
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2019
- Study start5 Feb 2020
- Primary completion24 Jun 2020
- Study completion24 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoparathyroidismStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Angers, Centre Hospitalier le Mans, University Hospital, Limoges, Central Hospital, Nancy, France, Pitié-Salpêtrière Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04053647
- Sponsor's protocol ID
- RC19_0021
- Status last verified
- Aug 2020
- First submitted
- 22 May 2019
- Last updated
- 7 Aug 2020
- 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 7 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life Evaluation (SF-36) in Patients With Permanent Hypoparathyroidism After Total Thyroidectomy
- ClinicalTrials.gov ID
- NCT04053647
- Acronym / sponsor ID
- RC19_0021
- Conditions
- Hypoparathyroidism, Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Collaborators
- University Hospital, Angers, Centre Hospitalier le Mans, University Hospital, Limoges, Central Hospital, Nancy, France, Pitié-Salpêtrière Hospital
- Study start
- 5 Feb 2020 (actual)
- Primary completion
- 24 Jun 2020 (actual)
- Study completion
- 24 Jun 2020 (actual)
- First posted
- 12 Aug 2019 (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.
Persistent hypoparathyroidism is an underestimate but major complication of total thyroidectomy. The hypothesis of the investigators is that the mental health is impaired in hypoparathyroid patients compared with thyroidectomized patients without hypoparathyroidism. The investigators evaluated the quality of life using the SF-36 survey in comparison with a control population of patients thyroidectomized but free from this complication. The voice quality, the cardiovascular risk, the kidney function and the incidence of urinary lithiasis were also evaluated.
Detailed description
Persistent hypoparathyroidism is an underestimate but major complication of total thyroidectomy. In this retrospective, observational, multicentre study, the investigators evaluated the quality of life using the SF-36 survey in comparison with a control population of patients thyroidectomized but free from this complication. Patients in six centers in France (Angers, Le Mans, Limoges, Nancy, Nantes, la Pitié-Salpétrière) and in the association "Hypoparathyroïdisme France" were contacted by mail. The primary endpoint was the mental health. The physic and global quality of life scores were assessed as secondary endpoints. Medical and VHI surveys were also send to the patients. The voice quality, the cardiovascular risk, the kidney function and the incidence of urinary lithiasis were also evaluated.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypoparathyroid patients | – | Other: Non-interventional studyPatients with persistent hypoparathyroidism after total thyroidectomy, defined as serum PTH inferior to 15 pg/mL 6 months after surgery and the need of vitamin-calcic supplementation. |
| Control patients, without hypoparathyroidism | – | Other: Non-interventional study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population is that of hypoparathyroid patients of the Hypoparathyroidism France combination who have undergone total thyroidectomy and who have agreed to participate in the study. Patients with permanent hypoparathyroidism who were included in the ThyrQol study and in the FOTHYR study will also be solicited. Endocrinologists at the University Hospital of Nantes also have patients with permanent hypoparathyroidism in their patients. The control population consists of patients who had a total thyroidectomy and were included in the ThyrQol study between 2014 and 2018, without sequelary hypoparathyroidism.
Key inclusion criteria (4 listed)
- Patients operated of total thyroidectomy
- Patients suffering from persistent hypoparathyroidism defined as serum PTH inferior to 15 pg/mL 6 months after the surgery, requiring vitamin-calcic supplementation.
- Age superior to 18
- Answering the survey
Key exclusion criteria (4 listed)
- Pregnancy at the time of the study
- Age inferior to 18 or adult under guardianship
- Patients with vitamino-calcic supplementation without serum PTH measurement
- Cause of hypoparathyroidism other than post-operatory.
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 |
|---|---|---|
| Non-interventional studyNon-interventional study | Other | Control patients, without hypoparathyroidism, Hypoparathyroid patients |
Primary outcome
Mental health
Time frame: Through study completion, an average of 1 year
Items from mental quality of life score defined by the SF36 (Short Form 36) survey
6 secondary outcomes
Physical quality score
Time frame: Through study completion, an average of 1 year
Global quality of life score
Time frame: Through study completion, an average of 1 year
Voice quality
Time frame: Through study completion, an average of 1 year
Renal function quality
Time frame: Through study completion, an average of 1 year
Presence of urinary lithiasis
Time frame: Through study completion, an average of 1 year
Presence of cardiovascular complications
Time frame: Through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2020.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypoparathyroidism and Quality of Life, run by Nantes University Hospital at 6 sites in France.
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 4 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: finished, as of the sponsor's last update on 7 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mental health (time frame: Through study completion, an average of 1 year). 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 7 Aug 2020.