CoHPT: Cohort Primary Hyperparathyroidism
Study Details
Study Description
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.
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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:
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To know the long-term consequences of the primary hyperparathyroidism treatment or observation.
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To better define the surgical indications
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To better understand the mechanisms of the cardiovascular impairment by using the biocollection
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To study the medico-economics consequences of the surgical management versus simple surveillance
Study Design
Outcome Measures
Primary Outcome Measures
- Occurrence of cardiovascular events, after parathyroidectomy for primary hyperparathyroidism [Between inclusion and 12 months after surgery]
Cardiovascular events include myocardial infarction, cerebrovascular and peripheral arterial events
- Change in LDL-cholesterol concentration after surgery [Between inclusion and 12 months after surgery]
Plasma LDL-cholesterol (mg/dL) will be directly measured using enzymatic method
- Change in HDL-cholesterol concentration after surgery [Between inclusion and 12 months after surgery]
Plasma HDL-cholesterol (mg/dL) will be measured using enzymatic method
- Change in plasma triglycerides concentration after surgery [Between inclusion and 12 months after surgery]
Plasma triglycerides (mg/dL) will be measured using enzymatic method
- Change in homeostasis model assessment HOMA-IR index after surgery [Between inclusion and 12 months 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
- Change in homeostasis model assessment HOMA-B index after surgery [Between inclusion and 12 months 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]
- Change in arterial stiffness after surgery [Between inclusion and 12 months after surgery]
Arterial stiffness is reflected by the measurement of the pulse wave velocity using the PoPmeter® instrument
Secondary Outcome Measures
- Occurrence of cardiovascular events, after parathyroidectomy for primary hyperparathyroidism [Between inclusion and 60 months after surgery]
Cardiovascular events include myocardial infarction, cerebrovascular and peripheral arterial events
- Change in LDL-cholesterol concentration after surgery [Between inclusion and 60 months after surgery]
Plasma LDL-cholesterol (mg/dL) will be directly measured using enzymatic method
- Change in HDL-cholesterol concentration after surgery [Between inclusion and 60 months after surgery]
Plasma HDL-cholesterol (mg/dL) will be measured using enzymatic method
- Change in plasma triglycerides concentration after surgery [Between inclusion and 60 months after surgery]
Plasma triglycerides (mg/dL) will be measured using enzymatic method
- Change in homeostasis model assessment HOMA-IR index after surgery [Between inclusion and 60 months 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
- Change in homeostasis model assessment HOMA-B index after surgery [Between inclusion and 60 months 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]
- Change in arterial stiffness after surgery [Between inclusion and 60 months after surgery]
Arterial stiffness is reflected by the measurement of the pulse wave velocity using the PoPmeter® instrument
- Change in bone mineral density after parathyroidectomy [Between inclusion and 12 months after surgery]
Bone mineral density is measured using Dual X-ray absorptiometry on lumbar spine, left hip, left femoral neck and left distal radius
- Change in bone-specific alkaline phosphatases [Between inclusion and 12 months after surgery]
Alkaline phosphatases (IU/L) are measured using ELISA enzymatic method
- Change in P1NP [Between inclusion and 12 months after surgery]
P1NP (µg/L) are measured using ELISA enzymatic method
- Change in plasma CTX [Between inclusion and 12 months after surgery]
CTX (µg/L) are measured using ELISA enzymatic method
- Change in bone mineral density after parathyroidectomy [Between inclusion and 60 months after surgery]
Bone mineral density is measured using Dual X-ray absorptiometry on lumbar spine, left hip, left femoral neck and left distal radius
- Change in bone-specific alkaline phosphatases [Between inclusion and 60 months after surgery]
Alkaline phosphatases (IU/L) are measured using ELISA enzymatic method
- Change in P1NP [Between inclusion and 60 months after surgery]
P1NP (µg/L) are measured using ELISA enzymatic method
- Change in plasma CTX [Between inclusion and 60 months after surgery]
CTX (µg/L) are measured using ELISA enzymatic method
- Change in the physical component score of the SF-36 questionnaire after surgery [Between inclusion and 36 months 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.)
- Change in the mental component score of the SF-36 questionnaire after surgery [Between inclusion and 36 months 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.
- Change in the physical component score of the SF-36 questionnaire after surgery [Between inclusion and 60 months 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.)
- Change in the mental component score of the SF-36 questionnaire after surgery [Between inclusion and 60 months 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.
- Change in renal outcomes (estimated glomerular filtration rate) after parathyroidectomy [Between inclusion and 60 months after surgery]
Estimated glomerular filtration rate will be calculated using the CKD-EPI equation from the measured serum creatinine
- Medico-economic impact of parathyroidectomy for primary hyperparathyroidism in comparison with simple surveillance [60 months after surgery]
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)
Eligibility Criteria
Criteria
Inclusion Criteria:
• Age > 18
Exclusion Criteria:
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Age < 18
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Pregnancy / lactation
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Adults underguardianship
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Secondary/tertiary hyperparathyroidism
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Multiple endocrine neoplasia
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Nantes University Hospital | Nantes | Loire-Atlantique | France | 44093 |
Sponsors and Collaborators
- Nantes University Hospital
- Institut National de la Santé Et de la Recherche Médicale, France
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RC15_0424