Monocentric Study on the Use of Teriparatide in Children With hypoparathyroïdism

NCT ID: NCT04126941

Last Updated: 2019-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

9 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-06-01

Study Completion Date

2020-12-31

Brief Summary

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Pediatric hypoparathyroidism is an orphan disease. Conventional management combines native and active vitamin D, calcium supplementation and sometimes phosphate binders, with the risk of long term hypercalciuria, nephrocalcinosis and further renal impairment. The use of teriparatide has been reported in adults (daily or bi-daily subcutaneous infusions) and in children (rather continuous subcutaneous infusion) as second-line therapy.

The objective of this study is to obtain efficacy and safety data on the use of teriparatide in children with hypoparathyroidism to improve our knowledge of their management.

Detailed Description

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Conditions

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Hypoparathyroidism

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Teriparatide

Patients with hypoparathyroidism treated by teriparatide

Serum calcium concentrations results

Intervention Type OTHER

To compare serum calcium concentrations results in patients with hypoparathyroidism before and three months after initiation of teriparatide therapy

Interventions

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Serum calcium concentrations results

To compare serum calcium concentrations results in patients with hypoparathyroidism before and three months after initiation of teriparatide therapy

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients with hypoparathyroidism
* Patients treated with teriparatide
* Patients followed in the reference center for calcium and phosphate metabolism diseases of Lyon.
* For children under 18: patient and parent (s) / parent having been informed of the study and having expressed their non-opposition

Exclusion Criteria

* No social security support
Minimum Eligible Age

2 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Service de Néphrologie, Rhumatologie et Dermatologie Pédiatriques - Hôpital Femme Mère Enfant

Bron, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Justine BACCHETTA, MD

Role: CONTACT

4 27 85 61 30 ext. +33

Sacha FLAMMIER, PHD

Role: CONTACT

4 27 85 66 69 ext. +33

Facility Contacts

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Justine BACCHETTA, MD

Role: primary

4 27 85 61 30 ext. +33

Other Identifiers

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2019 FOR-HYPO

Identifier Type: -

Identifier Source: org_study_id

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