AzTrials
AzTrials

Primary HyperparathyroidismCoHPTNCT05469087

Cohort Primary Hyperparathyroidism

An observational study of Primary Hyperparathyroidism, run by Nantes University Hospital at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

CoHPT is a prospective, monocentric, observational cohort including all patients diagnosed with primary hyperparathyroidism in Nantes University Hospital, aiming to study the outcomes associated with parathyroidectomy. Clinical and biochemical evaluation is performed at the inclusion, and 6, 12, 36 and 60 months. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Primary Hyperparathyroidism
How many people
403 participants
Where
1 siteFrance
Study dates
31 Mar 2016to 24 Feb 2027
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
  • Adult, Older adult

Study population: All consecutive patients consulting for sporadic primary hyperparathyroidism in Nantes University Hospital

Who may be able to join

  • Age > 18

Who cannot join

  • Age < 18
  • Pregnancy / lactation
  • Adults underguardianship
  • Secondary/tertiary hyperparathyroidism
  • Multiple endocrine neoplasia

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Eric MIRALLIE, PHD contact

33 2 40 08 31 66

eric.mirallie@chu-nantes.fr

France1 site, 1 recruiting

  • Nantes University Hospital

    Nantes, Loire-Atlantique, 44093

    Recruiting

Other trials in France

About this study

Official title: Prospective Cohort Primary Hyperparathyroidism

CoHPT is a prospective, monocentric, observational cohort including all patients diagnosed with primary hyperparathyroidism in Nantes University Hospital, aiming to study the outcomes associated with parathyroidectomy. Clinical and biochemical evaluation is performed at the inclusion, and 6, 12, 36 and 60 months. A biocollection is collected. The main hypotheses are that parathyroidectomy could improve cardiovascular, renal, bone, and cardiovascular outcomes along with quality of life.

Read the detailed description

Primaty hyperparathyroidism is the third most frequent endocrine disorder, which only curative treatment is the parathyroidectomy (approximately 8000/year). However, evidences suggest that the mildest forms of PHPT could be safely monitored with simple surveillance. However, to define surgical indications is challenging because data regarding the impach of surgery on several outcomes (namely cardiovascular, bone, renal or quality of life) are controversial.

CoHPT is a prospective, monocentric, observational cohort including all consecutive patients diagnosed with sporadic primary hyperparathyroidism in Nantes University Hospital aiming to study the outcomes associated with parathyroidectomy. Patients are followed even if surgery is not performed.

A systematic clinical and biochemical evaluation is performed at the inclusion, and 6, 12, 36 and 60 months. These informations include demographic and general medical data, pre-operative imaging exams, post-operative outcomes, histopathological analysis, evaluation of the impact of primary hyperparathyroidism and its surgery on target organs (bone, kidney, cardiovascular) and quality of life. Fasting blood samples are also collected to constitute a biocollection, in order to measure biomarkers related to the bone remodeling and the cardiovascular risk.

The objectives are:

  • To know the long-term consequences of the primary hyperparathyroidism treatment or observation.
  • To better define the surgical indications
  • To better understand the mechanisms of the cardiovascular impairment by using the biocollection
  • To study the medico-economics consequences of the surgical management versus simple surveillance
Keywords
Primary hyperparathyroidism, Parathyroidectomy
Medical subject headings
Hyperparathyroidism, Primary

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Occurrence of cardiovascular events, after parathyroidectomy for primary hyperparathyroidism

    Cardiovascular events include myocardial infarction, cerebrovascular and peripheral arterial events

    Measured: Between inclusion and 12 months after surgery

  2. Change in LDL-cholesterol concentration after surgery

    Plasma LDL-cholesterol (mg/dL) will be directly measured using enzymatic method

    Measured: Between inclusion and 12 months after surgery

  3. Change in HDL-cholesterol concentration after surgery

    Plasma HDL-cholesterol (mg/dL) will be measured using enzymatic method

    Measured: Between inclusion and 12 months after surgery

  4. Change in plasma triglycerides concentration after surgery

    Plasma triglycerides (mg/dL) will be measured using enzymatic method

    Measured: Between inclusion and 12 months after surgery

  5. Change in homeostasis model assessment HOMA-IR index after surgery

    HOMA-IR is calculated using fasting plasma glucose and insulin level, with the following formula: (fasting plasma insulin (mIU/L) × fasting plasma glucose (mmol/L))/22.5

    Measured: Between inclusion and 12 months after surgery

  6. Change in homeostasis model assessment HOMA-B index after surgery

    HOMA-B is calculated using fasting plasma glucose and insulin level, with the following formula: 20 × fasting plasma insulin (mIU/L)/[fasting plasma glucose (mmol/L) - 3.5]

    Measured: Between inclusion and 12 months after surgery

  7. Change in arterial stiffness after surgery

    Arterial stiffness is reflected by the measurement of the pulse wave velocity using the PoPmeter® instrument

    Measured: Between inclusion and 12 months after surgery

Secondary outcomes (21)

  1. Occurrence of cardiovascular events, after parathyroidectomy for primary hyperparathyroidism

    Cardiovascular events include myocardial infarction, cerebrovascular and peripheral arterial events

    Measured: Between inclusion and 60 months after surgery

  2. Change in LDL-cholesterol concentration after surgery

    Plasma LDL-cholesterol (mg/dL) will be directly measured using enzymatic method

    Measured: Between inclusion and 60 months after surgery

  3. Change in HDL-cholesterol concentration after surgery

    Plasma HDL-cholesterol (mg/dL) will be measured using enzymatic method

    Measured: Between inclusion and 60 months after surgery

  4. Change in plasma triglycerides concentration after surgery

    Plasma triglycerides (mg/dL) will be measured using enzymatic method

    Measured: Between inclusion and 60 months after surgery

  5. Change in homeostasis model assessment HOMA-IR index after surgery

    HOMA-IR is calculated using fasting plasma glucose and insulin level, with the following formula: (fasting plasma insulin (mIU/L) × fasting plasma glucose (mmol/L))/22.5

    Measured: Between inclusion and 60 months after surgery

  6. Change in homeostasis model assessment HOMA-B index after surgery

    HOMA-B is calculated using fasting plasma glucose and insulin level, with the following formula: 20 × fasting plasma insulin (mIU/L)/[fasting plasma glucose (mmol/L) - 3.5]

    Measured: Between inclusion and 60 months after surgery

  7. Change in arterial stiffness after surgery

    Arterial stiffness is reflected by the measurement of the pulse wave velocity using the PoPmeter® instrument

    Measured: Between inclusion and 60 months after surgery

  8. Change in bone mineral density after parathyroidectomy

    Bone mineral density is measured using Dual X-ray absorptiometry on lumbar spine, left hip, left femoral neck and left distal radius

    Measured: Between inclusion and 12 months after surgery

  9. Change in bone-specific alkaline phosphatases

    Alkaline phosphatases (IU/L) are measured using ELISA enzymatic method

    Measured: Between inclusion and 12 months after surgery

  10. Change in P1NP

    P1NP (µg/L) are measured using ELISA enzymatic method

    Measured: Between inclusion and 12 months after surgery

  11. Change in plasma CTX

    CTX (µg/L) are measured using ELISA enzymatic method

    Measured: Between inclusion and 12 months after surgery

  12. Change in bone mineral density after parathyroidectomy

    Bone mineral density is measured using Dual X-ray absorptiometry on lumbar spine, left hip, left femoral neck and left distal radius

    Measured: Between inclusion and 60 months after surgery

  13. Change in bone-specific alkaline phosphatases

    Alkaline phosphatases (IU/L) are measured using ELISA enzymatic method

    Measured: Between inclusion and 60 months after surgery

  14. Change in P1NP

    P1NP (µg/L) are measured using ELISA enzymatic method

    Measured: Between inclusion and 60 months after surgery

  15. Change in plasma CTX

    CTX (µg/L) are measured using ELISA enzymatic method

    Measured: Between inclusion and 60 months after surgery

  16. Change in the physical component score of the SF-36 questionnaire after surgery

    The physical component score is calculated from 4 items of the SF-36 questionnaire related to physical health. Results are expressed as a ratio between the included patients with values expected in an age- and sex-matched French reference population (available in Perneger T, Leplège A, Ecosse E. Le questionnaire MOS SF-36: manuel de l'utilisateur et guide d'interprétation des scores; Paris: Editions Estem. 2001:1-156.)

    Measured: Between inclusion and 36 months after surgery

  17. Change in the mental component score of the SF-36 questionnaire after surgery

    The mental component score is calculated from 4 items of the SF-36 questionnaire related to mental health. Results are expressed as a ratio between the included patients with values expected in an age- and sex-matched French reference population.

    Measured: Between inclusion and 36 months after surgery

  18. Change in the physical component score of the SF-36 questionnaire after surgery

    The physical component score is calculated from 4 items of the SF-36 questionnaire related to physical health. Results are expressed as a ratio between the included patients with values expected in an age- and sex-matched French reference population (available in Perneger T, Leplège A, Ecosse E. Le questionnaire MOS SF-36: manuel de l'utilisateur et guide d'interprétation des scores; Paris: Editions Estem. 2001:1-156.)

    Measured: Between inclusion and 60 months after surgery

  19. Change in the mental component score of the SF-36 questionnaire after surgery

    The mental component score is calculated from 4 items of the SF-36 questionnaire related to mental health. Results are expressed as a ratio between the included patients with values expected in an age- and sex-matched French reference population.

    Measured: Between inclusion and 60 months after surgery

  20. Change in renal outcomes (estimated glomerular filtration rate) after parathyroidectomy

    Estimated glomerular filtration rate will be calculated using the CKD-EPI equation from the measured serum creatinine

    Measured: Between inclusion and 60 months after surgery

  21. Medico-economic impact of parathyroidectomy for primary hyperparathyroidism in comparison with simple surveillance

    Takes into account the incidence of the worsening of cardiac and bone comorbidities and surgical complications. Data will be cross-referenced by probabilistic matching with the data of the Système National d'Information Interrégimes d'Assurance Maladie (SNIIR-AM)

    Measured: 60 months after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jul 2022
  2. Study start31 Mar 2016
  3. Primary completion24 Feb 2022
  4. Study completion24 Feb 2027 (estimated)

Resources

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
403 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05469087
Sponsor's protocol ID
RC15_0424
Acronym
CoHPT
Status last verified
Aug 2025
First submitted
7 Jul 2022
Last updated
8 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Loison M, Wargny M, Caillard C, Guillot P, Le Bras M, Cariou B, Blanchard C, Mirallie E, Frey S. Radius Bone Mineral Density Measurement Is Essential During Initial PHPT Workup: Results of a Retrospective Study on 400 Patients. World J Surg. 2026 Feb;50(2):441-450. doi: 10.1002/wjs.70223. Epub 2026 Jan 4.

    PubMed 41486083

  • Frey S, Perrot B, Caillard C, Le Bras M, Gerard M, Blanchard C, Cariou B, Wargny M, Mirallie E. Parathyroidectomy for primary hyperparathyroidism: effect on quality of life after 3 years - a prospective cohort study. Int J Surg. 2023 Mar 1;109(3):364-373. doi: 10.1097/JS9.0000000000000282.

    PubMed 36917123

Questions about this trial

What is this clinical trial studying?

An observational study of Primary Hyperparathyroidism, run by Nantes University Hospital 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 1 inclusion and 5 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 8 Sep 2025. 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?

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 Eric MIRALLIE, PHD (33 2 40 08 31 66, eric.mirallie@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence of cardiovascular events, after parathyroidectomy for primary hyperparathyroidism (time frame: Between inclusion and 12 months after surgery). The study lists 7 primary outcomes in all. 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 NCT05469087, which also lists 2 linked publications.

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 8 Sep 2025; AzTrials last refreshed its copy on 29 Oct 2026.

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