NCT05469087

Cohort Primary Hyperparathyroidism

Prospective Cohort Primary Hyperparathyroidism

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 403 (estimated)
• Sponsor: Nantes University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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

Conditions

• Primary Hyperparathyroidism

Timeline

• Start date: 2016-03-31
• Primary completion: 2022-02-24
• Completion: 2027-02-24
• First posted: 2022-07-21
• Last updated: 2025-09-08

Locations

1 site across 1 country: France