Hyperparathyroidism, Primary, Hyperparathyroidism, Secondary
Conditions
Keywords
Hyperparathyroidism, pathology phosphocalcic
Brief summary
Currently, the indications used for MA (Marketing Authorization) Cinacalcet in France are hyperparathyroidism (hyperPTH) in adults, whether primary (for patients in whom parathyroidectomy is theoretically indicated but in whom it is contraindicated or not is not clinically appropriate) or secondary to a chronic kidney disease, and parathyroid carcinomas. In pediatric patients, data on its use are restricted due to its recent marketing authorization (2017) and limited to dialysis patients suffering from secondary hyperPTH. Nevertheless, some patients with phosphocalcic pathologies without renal insufficiency must be treated off-label by cinacalcet in the presence of severe hyperPTH, without any other chronic treatment available to date. The objective of this study is therefore to evaluate the use in France of cinacalcet in phosphocalcic pathologies without renal insufficiency, in order to obtain efficacy and safety data in order to improve our knowledge on the management of these orphan diseases.
Interventions
OTHERSerum PTH concentrations results
To compare serum PTH concentrations results in patients with primary or secondary hyperPTH resulting from phosphocalcic pathology before and three months after initiation of cinacalcet therapy.
Sponsors
Hospices Civils de Lyon
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 99 Years
Healthy volunteers
No
Inclusion criteria
* Patients with phosphocalcic pathology without end-stage renal failure * Patients followed in one of the hospitals of the centers of reference and competence of the diseases of the metabolism of calcium and phosphate * For children under 18: patient and parent (s) / parent having been informed of the study and having expressed their on-opposition * For adults: patient / legal guardian of the patient under guardianship having been informed of the study and expressing his or her non opposition
Exclusion criteria
* Patient suffering from parathyroid cancer, * Patient suffering from primary hyperPTH in whom parathyroidectomy would theoretically be indicated but contraindicated or clinically inappropriate, * Patient suffering from hyperPTH secondary to end-stage renal failure * No social security support
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum PTH concentration | 3 months after treatment initiation |
Secondary
| Measure | Time frame |
|---|---|
| Serum PTH concentration | 1 month after treatment initiation |
Countries
France
Contacts
Primary ContactJustine BACCHETTA, MD
Backup ContactSacha FLAMMIER, PHD
Outcome results
None listed