HypoparathyroidismNCT02924532
Postoperative Dose of Parathyroid Hormone as a Marker for the Occurrence of Hypoparathyroidism After Total Thyroidectomy
An observational study of Hypoparathyroidism, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
The main objective of this study is to establish an optimal threshold Early parathormon (PTH) assay in order to exclude hypoparathyroidism , that is to say to obtain a negative predictive value of hypoparathyroidism highest possible. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypoparathyroidism
- What is being tested?
- immediate post operative bioassay of Parathyroid Hormone
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2012to 31 Dec 2018
- 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: Included patients underwent total thyroidectomy from 1 February 2012 to 1 December 2013 at the Nîmes University Hospital
Who may be able to join
- Patients consecutively operated on between February 1, 2012 and December 1, 2013
- Total thyroidectomy +/- lymphadenectomy
- Respect of clinicobiological protocol presented above
- The ( the ) patient ( e) was informed ( e) on the implementation of the study 's objectives, constraints and patient rights
- The ( the ) patient ( e) is under ( e) at least 18 years
Who cannot join
- The ( the ) patient ( e) is under guardianship, curatorship or under guard saves justice
- It is not possible to give to ( the ) patient ( e) informed information
- History of cervical radiotherapy
- Previous history of dysfunction of the parathyroid glands
- Previous history of surgery of the parathyroid glands
- A history of kidney failure or hepatocellular
Show all 9Show fewer
- History of osteomalacia or Paget's disease
- unhealed cancer antecedent
- History of sarcoidosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diagnostic Value of Immediate Postoperative Dose of Parathyroid Hormone as a Marker for the Occurrence of Hypoparathyroidism After Total Thyroidectomy: A Retrospective Observational Study
The main objective of this study is to establish an optimal threshold Early parathormon (PTH) assay in order to exclude hypoparathyroidism , that is to say to obtain a negative predictive value of hypoparathyroidism highest possible.
- Conditions
- Hypoparathyroidism
- Being tested
- immediate post operative bioassay of Parathyroid Hormone
- Medical subject headings
- Hypoparathyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immediate post operative bioassay of Parathyroid HormoneBiological
| Study group | Role | What they receive |
|---|---|---|
| Patients with total thiroidectomy | Not described Receives: Biological: immediate post operative bioassay of Parathyroid Hormone |
What is being measured
The primary outcome is the main question the study is designed to answer.
the presence/absence of hypoparathyroidism
hypoparathyroidism is defined as: corrected serum calcium Day 1 <1.90 and / or symptoms of hypocalcemia (cramps, tingling of the extremities and peri-oral) to Day 1 authenticated by a VAS score> 3.
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2016 (estimated)
- Study startFeb 2012
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypoparathyroidismStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02924532
- Sponsor's protocol ID
- LOCAL/2014/BL-01
- Status last verified
- Sep 2016
- First submitted
- 13 Sep 2016
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Galy-Bernadoy C, Lallemant B, Chambon G, Pham HT, Reynaud C, Alovisetti C, Bonduelle Q, Guedj AM, Lumbroso S, De Brauwere DP. Parathyroid Hormone Assays following Total Thyroidectomy: Is There a Predictive Value? Eur Thyroid J. 2018 Jan;7(1):34-38. doi: 10.1159/000484689. Epub 2017 Dec 7.
PubMed 29594052
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Value of Immediate Postoperative Dose of Parathyroid Hormone as a Marker for the Occurrence of Hypoparathyroidism After Total Thyroidectomy: A Retrospective Observational Study
- ClinicalTrials.gov ID
- NCT02924532
- Acronym / sponsor ID
- LOCAL/2014/BL-01
- Conditions
- Hypoparathyroidism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 5 Oct 2016 (estimated)
- 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 main objective of this study is to establish an optimal threshold Early parathormon (PTH) assay in order to exclude hypoparathyroidism , that is to say to obtain a negative predictive value of hypoparathyroidism highest possible.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with total thiroidectomy | – | Biological: immediate post operative bioassay of Parathyroid Hormone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Included patients underwent total thyroidectomy from 1 February 2012 to 1 December 2013 at the Nîmes University Hospital
Key inclusion criteria (5 listed)
- Patients consecutively operated on between February 1, 2012 and December 1, 2013
- Total thyroidectomy +/- lymphadenectomy
- Respect of clinicobiological protocol presented above
- The ( the ) patient ( e) was informed ( e) on the implementation of the study 's objectives, constraints and patient rights
- The ( the ) patient ( e) is under ( e) at least 18 years
Key exclusion criteria (9 listed)
- The ( the ) patient ( e) is under guardianship, curatorship or under guard saves justice
- It is not possible to give to ( the ) patient ( e) informed information
- History of cervical radiotherapy
- Previous history of dysfunction of the parathyroid glands
- Previous history of surgery of the parathyroid glands
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 |
|---|---|---|
| immediate post operative bioassay of Parathyroid Hormone | Biological | Patients with total thiroidectomy |
Primary outcome
the presence/absence of hypoparathyroidism
Time frame: day 1
hypoparathyroidism is defined as: corrected serum calcium Day 1 <1.90 and / or symptoms of hypocalcemia (cramps, tingling of the extremities and peri-oral) to Day 1 authenticated by a VAS score> 3.
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 18 Jun 2026.
- Results publication: PubMed 29594052Galy-Bernadoy C, Lallemant B, Chambon G, Pham HT, Reynaud C, Alovisetti C, Bonduelle Q, Guedj AM, Lumbroso S, De Brauwere DP. Parathyroid Hormone Assays following Total Thyroidectomy: Is There a Predictive Value? Eur Thyroid J. 2018 Jan;7(1):34-38. doi: 10.1159/000484689. Epub 2017 Dec 7.
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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.
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 Hypoparathyroidism, run by Centre Hospitalier Universitaire de Nīmes at 1 site 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 5 inclusion and 9 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 18 Jun 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 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?
the presence/absence of hypoparathyroidism (time frame: day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02924532, which also lists 1 linked publication.
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 18 Jun 2026.