Study on the Use of Cinacalcet in Phosphocalcic Context.

Study Overview
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Brief Summary
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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.

Official Title
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Multicentric Retrospective Study on the Use of Cinacalcet in an Off-label Phosphocalcic Context

Conditions
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Hyperparathyroidism, Secondary, Hyperparathyroidism, Primary

Intervention / Treatment
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* Other: Serum PTH concentrations results


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cinacalcet<br>Patients with primary or secondary hyperPTH resulting from phosphocalcic pathology treated by cinacalcet | Other: Serum PTH concentrations results<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum PTH concentration |  | 3 months after treatment initiation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum PTH concentration |  | 1 month after treatment initiation | 
| Serum PTH concentration |  | 6 months after treatment initiation | 
| Serum PTH concentration |  | 12 months after treatment initiation | 
| Serum PTH concentration |  | 3 years after treatment initiation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hyperparathyroidism, pathology phosphocalcic