NCT04126954

Study on the Use of Cinacalcet in Phosphocalcic Context.

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 25 (estimated)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: All
• Age: 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hyperparathyroidism, Secondary
• Hyperparathyroidism, Primary

Interventions

Type	Name	Description
OTHER	Serum 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.

Timeline

• Start date: 2020-01-01
• Primary completion: 2021-01-01
• Completion: 2023-12-01
• First posted: 2019-10-15
• Last updated: 2019-10-15

Locations

10 sites across 1 country: France