Cohort Primary Hyperparathyroidism

Primary Hyperparathyroidism Clinical Trial

— CoHPT  

Official title:

Prospective Cohort Primary Hyperparathyroidism

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05469087
• Other study ID #: RC15_0424
• Status: Recruiting
• Start date: March 31, 2016
• Est. completion date: February 24, 2027

Study information

• Verified date: July 2022
• Source: Nantes University Hospital
• Contact: Eric MIRALLIE, PHD
• Phone: 33 2 40 08 31 66
• Email: eric.mirallie[@]chu-nantes.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 403
• Est. completion date: February 24, 2027
• Est. primary completion date: February 24, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age > 18

Exclusion Criteria:

• Age < 18

• Pregnancy / lactation

• Adults underguardianship

• Secondary/tertiary hyperparathyroidism

• Multiple endocrine neoplasia

Related Conditions & MeSH terms

• Hyperparathyroidism
• Hyperparathyroidism, Primary
• Primary Hyperparathyroidism

Locations

Country	Name	City	State
France	Nantes University Hospital	Nantes	Loire-Atlantique

Sponsors (2)

Lead Sponsor	Collaborator
Nantes University Hospital	Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Change in plasma triglycerides concentration after surgery	Plasma triglycerides (mg/dL) will be measured using enzymatic method	Between inclusion and 12 months after surgery
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	Change in plasma triglycerides concentration after surgery	Plasma triglycerides (mg/dL) will be measured using enzymatic method	Between inclusion and 60 months after surgery
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change in bone-specific alkaline phosphatases	Alkaline phosphatases (IU/L) are measured using ELISA enzymatic method	Between inclusion and 12 months after surgery
Secondary	Change in P1NP	P1NP (µg/L) are measured using ELISA enzymatic method	Between inclusion and 12 months after surgery
Secondary	Change in plasma CTX	CTX (µg/L) are measured using ELISA enzymatic method	Between inclusion and 12 months after surgery
Secondary	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
Secondary	Change in bone-specific alkaline phosphatases	Alkaline phosphatases (IU/L) are measured using ELISA enzymatic method	Between inclusion and 60 months after surgery
Secondary	Change in P1NP	P1NP (µg/L) are measured using ELISA enzymatic method	Between inclusion and 60 months after surgery
Secondary	Change in plasma CTX	CTX (µg/L) are measured using ELISA enzymatic method	Between inclusion and 60 months after surgery
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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