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NCT Number: NCT05469087

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.

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Key information

Conditions

Primary Hyperparathyroidism Endocrine System Diseases Hyperparathyroidism Hyperparathyroidism, Primary Parathyroid Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nantes University Hospital

Nantes, Loire-Atlantique, 44093, France

Location status: Recruiting

About this study

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

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age > 18

Exclusion criteria

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

Treatment and study plan

Primary outcomes

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

    Time frame: Between inclusion and 12 months after surgery

    Cardiovascular events include myocardial infarction, cerebrovascular and peripheral arterial events

  2. Change in LDL-cholesterol concentration after surgery

    Time frame: Between inclusion and 12 months after surgery

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

  3. Change in HDL-cholesterol concentration after surgery

    Time frame: Between inclusion and 12 months after surgery

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

  4. Change in plasma triglycerides concentration after surgery

    Time frame: Between inclusion and 12 months after surgery

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

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

    Time frame: Between inclusion and 12 months 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

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

    Time frame: Between inclusion and 12 months 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]

  7. Change in arterial stiffness after surgery

    Time frame: Between inclusion and 12 months after surgery

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

Secondary outcomes

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

    Time frame: Between inclusion and 60 months after surgery

    Cardiovascular events include myocardial infarction, cerebrovascular and peripheral arterial events

  2. Change in LDL-cholesterol concentration after surgery

    Time frame: Between inclusion and 60 months after surgery

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

  3. Change in HDL-cholesterol concentration after surgery

    Time frame: Between inclusion and 60 months after surgery

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

  4. Change in plasma triglycerides concentration after surgery

    Time frame: Between inclusion and 60 months after surgery

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

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

    Time frame: Between inclusion and 60 months 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

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

    Time frame: Between inclusion and 60 months 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]

  7. Change in arterial stiffness after surgery

    Time frame: Between inclusion and 60 months after surgery

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

  8. Change in bone mineral density after parathyroidectomy

    Time frame: Between inclusion and 12 months after surgery

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

  9. Change in bone-specific alkaline phosphatases

    Time frame: Between inclusion and 12 months after surgery

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

  10. Change in P1NP

    Time frame: Between inclusion and 12 months after surgery

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

  11. Change in plasma CTX

    Time frame: Between inclusion and 12 months after surgery

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

  12. Change in bone mineral density after parathyroidectomy

    Time frame: Between inclusion and 60 months after surgery

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

  13. Change in bone-specific alkaline phosphatases

    Time frame: Between inclusion and 60 months after surgery

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

  14. Change in P1NP

    Time frame: Between inclusion and 60 months after surgery

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

  15. Change in plasma CTX

    Time frame: Between inclusion and 60 months after surgery

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

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

    Time frame: Between inclusion and 36 months 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.)

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

    Time frame: Between inclusion and 36 months 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.

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

    Time frame: Between inclusion and 60 months 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.)

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

    Time frame: Between inclusion and 60 months 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.

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

    Time frame: Between inclusion and 60 months after surgery

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

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

    Time frame: 60 months after surgery

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

Eric MIRALLIE, PHD

CONTACT

[email protected]

33 2 40 08 31 66

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Collaborators

  • Institut National de la Santé Et de la Recherche Médicale, France

Registry information

Official study title

Prospective Cohort Primary Hyperparathyroidism

Acronym: CoHPT

Important dates

Study start
2016
Primary completion
2022
Study completion
2027
First posted
Jul 21, 2022
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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