An observational study in Hyperparathyroidism, Secondary and Hyperparathyroidism, Primary, sponsored by Hospices Civils de Lyon. Status unknown at 10 sites in France. Open to participants aged Up to 99 Years. Per ClinicalTrials.gov, last updated 2019-10-15.
Sponsored by Hospices Civils de Lyon · Observational
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.
190 studies on the registry are indexed under Hyperparathyroidism, Secondary; 15 are open to participants now.
This study's planned enrollment of 25 is below the median of 102 across 35 observational studies indexed under Hyperparathyroidism, Secondary.
Browse Hyperparathyroidism, Secondary studies →Hospices Civils de Lyon is the lead sponsor of 1,856 studies on the registry; 442 are open to participants now.
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Patients with phosphocalcic diseases suffering from hyperPTH without end-stage renal failure.
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Exclusion Criteria:
Patients with primary or secondary hyperPTH resulting from phosphocalcic pathology treated by cinacalcet
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.
Serum PTH concentration
Time frame: 3 months after treatment initiation
Serum PTH concentration
Time frame: 1 month after treatment initiation
Serum PTH concentration
Time frame: 6 months after treatment initiation
Serum PTH concentration
Time frame: 12 months after treatment initiation
Serum PTH concentration
Time frame: 3 years after treatment initiation
This study is status unknown, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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Hyperparathyroidism, Secondary →