Cohort Primary Hyperparathyroidism
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Primary Hyperparathyroidism. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Prospective Cohort Primary Hyperparathyroidism
Overview
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
Primary outcome measures
- Occurrence of cardiovascular events, after parathyroidectomy for primary hyperparathyroidism [Time frame: Between inclusion and 12 months after surgery]
- Change in LDL-cholesterol concentration after surgery [Time frame: Between inclusion and 12 months after surgery]
- Change in HDL-cholesterol concentration after surgery [Time frame: Between inclusion and 12 months after surgery]
- Change in plasma triglycerides concentration after surgery [Time frame: Between inclusion and 12 months after surgery]
- Change in homeostasis model assessment HOMA-IR index after surgery [Time frame: Between inclusion and 12 months after surgery]
- Change in homeostasis model assessment HOMA-B index after surgery [Time frame: Between inclusion and 12 months after surgery]
- Change in arterial stiffness after surgery [Time frame: Between inclusion and 12 months after surgery]
Secondary outcome measures (12)
- Occurrence of cardiovascular events, after parathyroidectomy for primary hyperparathyroidism [Time frame: Between inclusion and 60 months after surgery]
- Change in LDL-cholesterol concentration after surgery [Time frame: Between inclusion and 60 months after surgery]
- Change in HDL-cholesterol concentration after surgery [Time frame: Between inclusion and 60 months after surgery]
- Change in plasma triglycerides concentration after surgery [Time frame: Between inclusion and 60 months after surgery]
- Change in homeostasis model assessment HOMA-IR index after surgery [Time frame: Between inclusion and 60 months after surgery]
- Change in homeostasis model assessment HOMA-B index after surgery [Time frame: Between inclusion and 60 months after surgery]
- Change in arterial stiffness after surgery [Time frame: Between inclusion and 60 months after surgery]
- Change in bone mineral density after parathyroidectomy [Time frame: Between inclusion and 12 months after surgery]
- Change in bone-specific alkaline phosphatases [Time frame: Between inclusion and 12 months after surgery]
- Change in P1NP [Time frame: Between inclusion and 12 months after surgery]
- Change in plasma CTX [Time frame: Between inclusion and 12 months after surgery]
- Change in bone mineral density after parathyroidectomy [Time frame: Between inclusion and 60 months after surgery]
Eligibility criteria
Inclusion criteria
- Age > 18
Exclusion criteria
- Age < 18
- Pregnancy / lactation
- Adults underguardianship
- Secondary/tertiary hyperparathyroidism
- Multiple endocrine neoplasia
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Nantes University Hospital — Nantes
Publications
- Loison M, Wargny M, Caillard C, Guillot P, Le Bras M, Cariou B, Blanchard C, Mirallie E, Frey S. Radius Bone Mineral Density Measurement Is Essential During Initial PHPT Workup: Results of a Retrospective Study on 400 Patients. World J Surg. 2026 Feb;50(2):441-450. doi: 10.1002/wjs.70223. Epub 2026 Jan 4. PMID 41486083
- 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. PMID 36917123
Identifiers
NCT: NCT05469087 · RC15_0424