Cohort Primary Hyperparathyroidism

NCT05469087 | Recruiting

• 1 other identifier: RC15_0424
• Study Type: observational
• Target: 403
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Hyperparathyroidism

Keywords

Primary hyperparathyroidism; Parathyroidectomy

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (21)

• Occurrence of cardiovascular events, after parathyroidectomy for primary hyperparathyroidism

  Between inclusion and 60 months after surgery

• Change in LDL-cholesterol concentration after surgery

  Between inclusion and 60 months after surgery

• Change in HDL-cholesterol concentration after surgery

  Between inclusion and 60 months after surgery

• Change in plasma triglycerides concentration after surgery

  Between inclusion and 60 months after surgery

• Change in homeostasis model assessment HOMA-IR index after surgery

  Between inclusion and 60 months after surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Age \> 18

You may not qualify if:

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

Sponsors & Collaborators

• Nantes University Hospital: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (1)

Nantes University Hospital

Nantes, Loire-Atlantique, 44093, France

RECRUITING

Related Publications (2)

• 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 Jan 4. doi: 10.1002/wjs.70223. Online ahead of print.

  PMID: 41486083 DERIVED

• 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 DERIVED

MeSH Terms

Conditions

Hyperparathyroidism, Primary

Condition Hierarchy (Ancestors)

Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases

Central Study Contacts

Eric MIRALLIE, PHD

CONTACT

33 2 40 08 31 66; eric.mirallie@chu-nantes.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2022
• First Posted: July 21, 2022
• Study Start: March 31, 2016
• Primary Completion: February 24, 2022
• Study Completion (Estimated): February 24, 2027
• Last Updated: September 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)