Cohort Primary Hyperparathyroidism (CoHPT)

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.

Study Overview

• Status: Recruiting
• Conditions: Primary Hyperparathyroidism

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

• Study Type: Observational
• Enrollment (Estimated): 403

Contacts and Locations

• Study Contact: Name: Eric MIRALLIE, PHD; Phone Number: 33 2 40 08 31 66; Email: eric.mirallie@chu-nantes.fr

Study Locations

• France
  • Loire-Atlantique
    • Nantes, Loire-Atlantique, France, 44093
      • Recruiting
      • Nantes University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• Age > 18

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of cardiovascular events, after parathyroidectomy for primary hyperparathyroidism	Cardiovascular events include myocardial infarction, cerebrovascular and peripheral arterial events	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	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	Between inclusion and 12 months after surgery
Change in plasma triglycerides concentration after surgery	Plasma triglycerides (mg/dL) will be measured using enzymatic method	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	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]	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	Between inclusion and 12 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of cardiovascular events, after parathyroidectomy for primary hyperparathyroidism	Cardiovascular events include myocardial infarction, cerebrovascular and peripheral arterial events	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	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	Between inclusion and 60 months after surgery
Change in plasma triglycerides concentration after surgery	Plasma triglycerides (mg/dL) will be measured using enzymatic method	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	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]	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	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	Between inclusion and 12 months after surgery
Change in bone-specific alkaline phosphatases	Alkaline phosphatases (IU/L) are measured using ELISA enzymatic method	Between inclusion and 12 months after surgery
Change in P1NP	P1NP (µg/L) are measured using ELISA enzymatic method	Between inclusion and 12 months after surgery
Change in plasma CTX	CTX (µg/L) are measured using ELISA enzymatic method	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	Between inclusion and 60 months after surgery
Change in bone-specific alkaline phosphatases	Alkaline phosphatases (IU/L) are measured using ELISA enzymatic method	Between inclusion and 60 months after surgery
Change in P1NP	P1NP (µg/L) are measured using ELISA enzymatic method	Between inclusion and 60 months after surgery
Change in plasma CTX	CTX (µg/L) are measured using ELISA enzymatic method	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.)	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.	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.)	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.	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	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)	60 months after surgery

Collaborators and Investigators

• Sponsor: Nantes University Hospital
• Collaborators: Institut National de la Santé Et de la Recherche Médicale, France

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2016
• Primary Completion (Actual): February 24, 2022
• Study Completion (Estimated): February 24, 2027

Study Registration Dates

• First Submitted: July 7, 2022
• First Submitted That Met QC Criteria: July 19, 2022
• First Posted (Actual): July 21, 2022

Study Record Updates

• Last Update Posted (Estimated): September 8, 2025
• Last Update Submitted That Met QC Criteria: August 29, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Primary hyperparathyroidism; Parathyroidectomy
• Additional Relevant MeSH Terms: Endocrine System Diseases; Parathyroid Diseases; Hyperparathyroidism; Hyperparathyroidism, Primary
• Other Study ID Numbers: RC15_0424

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No