Monocentric Study on the Use of Teriparatide in Children With hypoparathyroïdism (FOR-HYPO)

October 11, 2019 updated by: Hospices Civils de Lyon

Bi-daily Injection of Subcutaneous Teriparatide in Children With Hypoparathyroidism: Single-center Experience

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

9

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bron, France
        • Recruiting
        • Service de Néphrologie, Rhumatologie et Dermatologie Pédiatriques - Hôpital Femme Mère Enfant
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with hypoPTH (Hypoparathyroidism) treated with teriparatide

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Teriparatide
Patients with hypoparathyroidism treated by teriparatide
Other: Serum calcium concentrations results
To compare serum calcium concentrations results in patients with hypoparathyroidism before and three months after initiation of teriparatide therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Serum calcium concentration
Time Frame: 3 months after treatment initiation
3 months after treatment initiation

Secondary Outcome Measures

Outcome Measure
Time Frame
Serum calcium concentration
Time Frame: 1 month after treatment initiation
1 month after treatment initiation
Serum calcium concentration
Time Frame: 6 months after treatment initiation
6 months after treatment initiation
Serum calcium concentration
Time Frame: 12 months after treatment initiation
12 months after treatment initiation
Serum calcium concentration
Time Frame: 3 years after treatment initiation
3 years after treatment initiation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 1, 2019

Primary Completion (ANTICIPATED)

June 1, 2020

Study Completion (ANTICIPATED)

December 1, 2020

Study Registration Dates

First Submitted

October 11, 2019

First Submitted That Met QC Criteria

October 11, 2019

First Posted (ACTUAL)

October 15, 2019

Study Record Updates

Last Update Posted (ACTUAL)

October 15, 2019

Last Update Submitted That Met QC Criteria

October 11, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019 FOR-HYPO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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