Monocentric Study on the Use of Teriparatide in Children With hypoparathyroïdism
FOR-HYPO
Bi-daily Injection of Subcutaneous Teriparatide in Children With Hypoparathyroidism: Single-center Experience
1 other identifier
observational
9
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jun 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2019
CompletedFirst Submitted
Initial submission to the registry
October 11, 2019
CompletedFirst Posted
Study publicly available on registry
October 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedOctober 15, 2019
October 1, 2019
1 year
October 11, 2019
October 11, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Serum calcium concentration
3 months after treatment initiation
Secondary Outcomes (4)
Serum calcium concentration
1 month after treatment initiation
Serum calcium concentration
6 months after treatment initiation
Serum calcium concentration
12 months after treatment initiation
Serum calcium concentration
3 years after treatment initiation
Study Arms (1)
Teriparatide
Patients with hypoparathyroidism treated by teriparatide
Interventions
To compare serum calcium concentrations results in patients with hypoparathyroidism before and three months after initiation of teriparatide therapy
Eligibility Criteria
Patients with hypoPTH (Hypoparathyroidism) treated with teriparatide
You may qualify if:
- 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
You may not qualify if:
- No social security support
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Service de Néphrologie, Rhumatologie et Dermatologie Pédiatriques - Hôpital Femme Mère Enfant
Bron, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 11, 2019
First Posted
October 15, 2019
Study Start
June 1, 2019
Primary Completion
June 1, 2020
Study Completion
December 1, 2020
Last Updated
October 15, 2019
Record last verified: 2019-10