Observational study on outcomes of parathyroidectomy in primary hyperparathyroidism
Prospective Cohort Primary Hyperparathyroidism
This study looks at how surgery for primary hyperparathyroidism affects patients' heart, kidney, and bone health, as well as their quality of life, over several years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 403 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Nantes University Hospital Academic / other |
| Locations | 1 site (Nantes, Loire-Atlantique) |
| Trial ID | NCT05469087 on ClinicalTrials.gov |
What this trial studies
This observational cohort study at Nantes University Hospital includes patients diagnosed with primary hyperparathyroidism to evaluate the outcomes associated with parathyroidectomy. Participants undergo clinical and biochemical assessments at baseline and at 6, 12, 36, and 60 months, regardless of whether they undergo surgery. The study aims to clarify the long-term effects of treatment versus observation on cardiovascular, renal, bone health, and quality of life. Additionally, a biocollection of fasting blood samples will be established to analyze biomarkers related to bone remodeling and cardiovascular risk.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old diagnosed with sporadic primary hyperparathyroidism.
Not a fit: Patients with secondary or tertiary hyperparathyroidism, those under 18, or individuals who are pregnant or lactating will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term benefits of parathyroidectomy, potentially improving patient management and outcomes.
How similar studies have performed: While there is ongoing debate regarding the surgical indications for mild forms of primary hyperparathyroidism, this study aims to contribute new data to an area with mixed evidence, making it a potentially novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: • Age \> 18 Exclusion Criteria: * Age \< 18 * Pregnancy / lactation * Adults underguardianship * Secondary/tertiary hyperparathyroidism * Multiple endocrine neoplasia
Where this trial is running
Nantes, Loire-Atlantique
- Nantes University Hospital — Nantes, Loire-Atlantique, France (Recruiting)
Study contacts
- Study coordinator: Eric MIRALLIE, PHD
- Email: eric.mirallie@chu-nantes.fr
- Phone: 33 2 40 08 31 66
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.