Radius Bone Mineral Density Measurement Is Essential During Initial PHPT Workup: Results of a Retrospective Study on 400 Patients.
Mélanie Loison, Matthieu Wargny, Cécile Caillard...
https://pubmed.ncbi.nlm.nih.gov/41486083Actively Recruiting
Age: 18Years +
All Genders
ID05469087
Prospective Cohort Study of Primary Hyperparathyroidism Outcomes at Nantes University Hospital
Led by Nantes University Hospital · Updated on 2025-09-08
403
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
Sponsors
N
Nantes University Hospital
Lead Sponsor
I
Institut National de la Santé Et de la Recherche Médicale, France
Collaborating Sponsor
AI-Summary
What this Trial Is About
Primary hyperparathyroidism is a common endocrine disorder, and this research aims to observe outcomes related to its main treatment, parathyroidectomy. The study focuses on understanding how surgery affects cardiovascular, bone, kidney health, and quality of life among patients diagnosed with this condition. It is a prospective, observational cohort study conducted at Nantes University Hospital that includes all patients diagnosed with sporadic primary hyperparathyroidism. Participants are observed whether or not they undergo parathyroidectomy. The study collects clinical and biochemical data at the start and at 6, 12, 36, and 60 months. Blood samples are also collected to analyze biomarkers related to bone remodeling and cardiovascular risk. Data include demographic information, imaging exams before surgery, outcomes after surgery, and assessments of the disease and treatment impact on target organs and quality of life. During the study, participants undergo regular evaluations including clinical exams, blood tests, and questionnaires assessing quality of life. Researchers monitor changes in cardiovascular events, cholesterol levels, insulin resistance, arterial stiffness, bone density, and kidney function over time. The study also examines the economic impact of surgical management compared to monitoring, with follow-up lasting up to five years after surgery or inclusion.
CONDITIONS
Brief Title
Cohort Primary Hyperparathyroidism
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age > 18
You will not qualify if you...
- Age < 18
- Pregnancy or lactation
- Adults under guardianship
- Secondary or tertiary hyperparathyroidism
- Multiple endocrine neoplasia
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surveillance
Duration - Up to 60 months
Participants diagnosed with primary hyperparathyroidism are observed with regular clinical and biochemical evaluations regardless of receiving surgery.
Visits at inclusion, 6, 12, 36, and 60 months
Post-operative Follow-up
Duration - Up to 60 months after surgery
Participants who undergo parathyroidectomy are followed to assess outcomes related to cardiovascular health, bone density, renal function, and quality of life.
Visits at inclusion, 6, 12, 36, and 60 months
Trial Site Locations
Total: 1 location
1
Nantes University Hospital
Nantes, Loire-Atlantique, France, 44093
Actively Recruiting
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Research Team
E
Eric MIRALLIE, PHD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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Published Research Related To This Trial
Parathyroidectomy for primary hyperparathyroidism: effect on quality of life after 3 years - a prospective cohort study.
Samuel Frey, Bastien Perrot, Cécile Caillard...
https://pubmed.ncbi.nlm.nih.gov/36917123