Clinical trial NCT05469087: Cohort Primary Hyperparathyroidism
Official title: Prospective Cohort Primary Hyperparathyroidism
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Primary Hyperparathyroidism
Keywords: Primary hyperparathyroidism
Parathyroidectomy
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2022-07-21
Enrollment: 403
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All consecutive patients consulting for sporadic primary hyperparathyroidism in Nantes University Hospital

Brief 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. A biocollection is collected. The main hypotheses are that parathyroidectomy could improve cardiovascular, renal, bone, and cardiovascular outcomes along with quality of life.

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

Eligibility criteria: Inclusion Criteria:

• Age \> 18

Exclusion Criteria:

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

Primary outcomes:
measure: Occurrence of cardiovascular events, after parathyroidectomy for primary hyperparathyroidism
timeFrame: Between inclusion and 12 months after surgery
measure: Change in LDL-cholesterol concentration after surgery
timeFrame: Between inclusion and 12 months after surgery
measure: Change in HDL-cholesterol concentration after surgery
timeFrame: Between inclusion and 12 months after surgery
measure: Change in plasma triglycerides concentration after surgery
timeFrame: Between inclusion and 12 months after surgery
measure: Change in homeostasis model assessment HOMA-IR index after surgery
timeFrame: Between inclusion and 12 months after surgery
measure: Change in homeostasis model assessment HOMA-B index after surgery
timeFrame: Between inclusion and 12 months after surgery
measure: Change in arterial stiffness after surgery
timeFrame: Between inclusion and 12 months after surgery
Secondary outcomes:
measure: Occurrence of cardiovascular events, after parathyroidectomy for primary hyperparathyroidism
timeFrame: Between inclusion and 60 months after surgery
measure: Change in LDL-cholesterol concentration after surgery
timeFrame: Between inclusion and 60 months after surgery
measure: Change in HDL-cholesterol concentration after surgery
timeFrame: Between inclusion and 60 months after surgery
measure: Change in plasma triglycerides concentration after surgery
timeFrame: Between inclusion and 60 months after surgery
measure: Change in homeostasis model assessment HOMA-IR index after surgery
timeFrame: Between inclusion and 60 months after surgery
measure: Change in homeostasis model assessment HOMA-B index after surgery
timeFrame: Between inclusion and 60 months after surgery
measure: Change in arterial stiffness after surgery
timeFrame: Between inclusion and 60 months after surgery
measure: Change in bone mineral density after parathyroidectomy
timeFrame: Between inclusion and 12 months after surgery
measure: Change in bone-specific alkaline phosphatases
timeFrame: Between inclusion and 12 months after surgery
measure: Change in P1NP
timeFrame: Between inclusion and 12 months after surgery
measure: Change in plasma CTX
timeFrame: Between inclusion and 12 months after surgery
measure: Change in bone mineral density after parathyroidectomy
timeFrame: Between inclusion and 60 months after surgery
measure: Change in bone-specific alkaline phosphatases
timeFrame: Between inclusion and 60 months after surgery
measure: Change in P1NP
timeFrame: Between inclusion and 60 months after surgery
measure: Change in plasma CTX
timeFrame: Between inclusion and 60 months after surgery
measure: Change in the physical component score of the SF-36 questionnaire after surgery
timeFrame: Between inclusion and 36 months after surgery
measure: Change in the mental component score of the SF-36 questionnaire after surgery
timeFrame: Between inclusion and 36 months after surgery
measure: Change in the physical component score of the SF-36 questionnaire after surgery
timeFrame: Between inclusion and 60 months after surgery
measure: Change in the mental component score of the SF-36 questionnaire after surgery
timeFrame: Between inclusion and 60 months after surgery
measure: Change in renal outcomes (estimated glomerular filtration rate) after parathyroidectomy
timeFrame: Between inclusion and 60 months after surgery
measure: Medico-economic impact of parathyroidectomy for primary hyperparathyroidism in comparison with simple surveillance
timeFrame: 60 months after surgery
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes University Hospital
state: Loire-Atlantique
Study officials:
References: