Study on the Use of Cinacalcet in Phosphocalcic Context.

• Conditions: Hyperparathyroidism, Secondary; Hyperparathyroidism, Primary
• Interventions: Other: Serum PTH concentrations results

• Registration Number: NCT04126954
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-10
• Study First Submitted: 2019-10-11
• Study First Submitted QC: 2019-10-11
• Last Update Submitted: 2019-10-11
• Study First Posted: 2019-10-15
• Last Update Posted: 2019-10-15
• Study Start: 2020-01
• Primary Completion: 2021-01
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 25

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cinacalcet	Serum PTH concentrations results	Patients with primary or secondary hyperPTH resulting from phosphocalcic pathology treated by cinacalcet

Primary Outcome Measures

Name	Time	Method
Serum PTH concentration	3 months after treatment initiation

Secondary Outcome Measures

Name	Time	Method
Serum PTH concentration	3 years after treatment initiation

Trial Locations

Locations (10)

Service de Néphrologie Pédiatrique -Hôpital Jeanne de Flandre; 🇫🇷 Lille, France

Pole Femme Mère Enfant - Pédiatrie spécialisée - Centre Hospitalier Universitaire; 🇫🇷 Montpellier, France

Service de Néphrologie pédiatrique - Clinique Médicale Pédiatrique; 🇫🇷 Nantes, France

Pôle Néphrologie-Urologie-Diabétologie-Endocrinologie; 🇫🇷 Strasbourg, France

Service de Diabétologie et endocrinologie pédiatriques - Centre Hospitalier Universitaire; 🇫🇷 Reims, France

Service d'Endocrinologie, Maladies Osseuses, Gynécologie, Génétique; 🇫🇷 Toulouse, France

Endocrinologie Diabète et Maladies Métaboliques - Hôpital Gabriel Montpied; 🇫🇷 Clermont-Ferrand, France

Service d'Endocrinologie Pédiatrique - Hôpital de la mère et de l'Enfant; 🇫🇷 Limoges, France

Service d'endocrinologie et Diabétologie Pédiatrique-Hôpital Robert Debré; 🇫🇷 Paris, France

Unité Endocrinologie, Nutrition, Diabétologie -Hôpital Bretonneau; 🇫🇷 Tours, France