An observational study in Primary Hyperparathyroidism, sponsored by Nantes University Hospital. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-08.
Sponsored by Nantes University Hospital · Observational
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.
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:
104 studies on the registry are indexed under Hyperparathyroidism, Primary; 23 are open to participants now.
This study's planned enrollment of 403 is above the median of 130 across 40 observational studies indexed under Hyperparathyroidism, Primary.
Browse Hyperparathyroidism, Primary studies →Nantes University Hospital is the lead sponsor of 839 studies on the registry; 195 are open to participants now.
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All consecutive patients consulting for sporadic primary hyperparathyroidism in Nantes University Hospital
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Exclusion Criteria:
Occurrence of cardiovascular events, after parathyroidectomy for primary hyperparathyroidism
Cardiovascular events include myocardial infarction, cerebrovascular and peripheral arterial events
Time frame: Between inclusion and 12 months after surgery
Change in LDL-cholesterol concentration after surgery
Plasma LDL-cholesterol (mg/dL) will be directly measured using enzymatic method
Time frame: Between inclusion and 12 months after surgery
Change in HDL-cholesterol concentration after surgery
Plasma HDL-cholesterol (mg/dL) will be measured using enzymatic method
Time frame: Between inclusion and 12 months after surgery
Change in plasma triglycerides concentration after surgery
Plasma triglycerides (mg/dL) will be measured using enzymatic method
Time frame: Between inclusion and 12 months after surgery
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
Time frame: Between inclusion and 12 months after surgery
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)/\[fasting plasma glucose (mmol/L) - 3.5\]
Time frame: Between inclusion and 12 months after surgery
Change in arterial stiffness after surgery
Arterial stiffness is reflected by the measurement of the pulse wave velocity using the PoPmeter® instrument
Time frame: Between inclusion and 12 months after surgery
Occurrence of cardiovascular events, after parathyroidectomy for primary hyperparathyroidism
Cardiovascular events include myocardial infarction, cerebrovascular and peripheral arterial events
Time frame: Between inclusion and 60 months after surgery
Change in LDL-cholesterol concentration after surgery
Plasma LDL-cholesterol (mg/dL) will be directly measured using enzymatic method
Time frame: Between inclusion and 60 months after surgery
Change in HDL-cholesterol concentration after surgery
Plasma HDL-cholesterol (mg/dL) will be measured using enzymatic method
Time frame: Between inclusion and 60 months after surgery
Change in plasma triglycerides concentration after surgery
Plasma triglycerides (mg/dL) will be measured using enzymatic method
Time frame: Between inclusion and 60 months after surgery
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
Time frame: Between inclusion and 60 months after surgery
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)/\[fasting plasma glucose (mmol/L) - 3.5\]
Time frame: Between inclusion and 60 months after surgery
Change in arterial stiffness after surgery
Arterial stiffness is reflected by the measurement of the pulse wave velocity using the PoPmeter® instrument
Time frame: Between inclusion and 60 months after surgery
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
Time frame: Between inclusion and 12 months after surgery
Change in bone-specific alkaline phosphatases
Alkaline phosphatases (IU/L) are measured using ELISA enzymatic method
Time frame: Between inclusion and 12 months after surgery
Change in P1NP
P1NP (µg/L) are measured using ELISA enzymatic method
Time frame: Between inclusion and 12 months after surgery
Change in plasma CTX
CTX (µg/L) are measured using ELISA enzymatic method
Time frame: Between inclusion and 12 months after surgery
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
Time frame: Between inclusion and 60 months after surgery
Change in bone-specific alkaline phosphatases
Alkaline phosphatases (IU/L) are measured using ELISA enzymatic method
Time frame: Between inclusion and 60 months after surgery
Change in P1NP
P1NP (µg/L) are measured using ELISA enzymatic method
Time frame: Between inclusion and 60 months after surgery
Change in plasma CTX
CTX (µg/L) are measured using ELISA enzymatic method
Time frame: Between inclusion and 60 months after surgery
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.)
Time frame: Between inclusion and 36 months after surgery
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.
Time frame: Between inclusion and 36 months after surgery
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.)
Time frame: Between inclusion and 60 months after surgery
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.
Time frame: Between inclusion and 60 months after surgery
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
Time frame: Between inclusion and 60 months after surgery
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)
Time frame: 60 months after surgery
Plan to share: No
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