Hypoparathyroidism Clinical Trial
— FOR-HYPOOfficial title:
Bi-daily Injection of Subcutaneous Teriparatide in Children With Hypoparathyroidism: Single-center Experience
| NCT number | NCT04126941 |
| Other study ID # | 2019 FOR-HYPO |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | June 1, 2019 |
| Est. completion date | December 2020 |
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.
| Status | Recruiting |
| Enrollment | 9 |
| Est. completion date | December 2020 |
| Est. primary completion date | June 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 2 Years to 18 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Service de Néphrologie, Rhumatologie et Dermatologie Pédiatriques - Hôpital Femme Mère Enfant | Bron |
| Lead Sponsor | Collaborator |
|---|---|
| Hospices Civils de Lyon |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Serum calcium concentration | 3 months after treatment initiation | ||
| Secondary | Serum calcium concentration | 1 month after treatment initiation | ||
| Secondary | Serum calcium concentration | 6 months after treatment initiation | ||
| Secondary | Serum calcium concentration | 12 months after treatment initiation | ||
| Secondary | Serum calcium concentration | 3 years after treatment initiation |
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