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NCT04126941 Clinical Trial

Monocentric Study on the Use of Teriparatide in Children With hypoparathyroïdism

Hypoparathyroidism Clinical Trial

— FOR-HYPO  

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

Clinical Trial Details — Status: Recruiting

Administrative data
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

Study information
Verified date October 2019
Source Hospices Civils de Lyon
Contact Justine BACCHETTA, MD
Phone 4 27 85 61 30
Email justine.bacchetta@chu-lyon.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
France Service de Néphrologie, Rhumatologie et Dermatologie Pédiatriques - Hôpital Femme Mère Enfant Bron

Sponsors (1)
Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome
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
See also
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Completed NCT02910466 - A Study of Extended Use of Recombinant Human Parathyroid Hormone (rhPTH(1-84)) in Hypoparathyroidism Phase 4
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Completed NCT00473265 - Bone Properties in Hypoparathyroidism: Effects of PTH Phase 2/Phase 3
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Completed NCT04059380 - Evaluation of iMmune Function in Post-surgical and AuToimmune HYpoparathyroidism (EMPATHY)
Active, not recruiting NCT05965167 - Assess Safety and Compare PK of New Oral hPTH(1-34) Tablet Formulations vs. EBP05 Tablets and Subcutaneous Forteo Phase 1/Phase 2
Recruiting NCT02986607 - Corticosteroid Rhythms in Hypoparathyroid Patients Early Phase 1
Completed NCT00793689 - Perioperative Parathormone Measurement and Sodium Bicarbonate Infusion Test After Total Thyroidectomy N/A
Completed NCT04671719 - Determination of Circulating Autotaxin in Patients With GNAS or PTH Abnormalities
Completed NCT04750460 - Injection of Teriparatide to Prevent Hypocalcemia After Parathyroidectomy in Dialysis Patients (TeriCa). Phase 3