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

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ClinicalTrials.gov Identifier: NCT04126941
Recruitment Status : Recruiting
First Posted : October 15, 2019
Last Update Posted : October 15, 2019
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

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.


Condition or disease Intervention/treatment
Hypoparathyroidism Other: Serum calcium concentrations results

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Study Type : Observational
Estimated Enrollment : 9 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Bi-daily Injection of Subcutaneous Teriparatide in Children With Hypoparathyroidism: Single-center Experience
Actual Study Start Date : June 1, 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium

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




Primary Outcome Measures :
  1. Serum calcium concentration [ Time Frame: 3 months after treatment initiation ]

Secondary Outcome Measures :
  1. Serum calcium concentration [ Time Frame: 1 month after treatment initiation ]
  2. Serum calcium concentration [ Time Frame: 6 months after treatment initiation ]
  3. Serum calcium concentration [ Time Frame: 12 months after treatment initiation ]
  4. Serum calcium concentration [ Time Frame: 3 years after treatment initiation ]


Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with hypoPTH (Hypoparathyroidism) treated with teriparatide
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04126941


Contacts
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Contact: Justine BACCHETTA, MD 4 27 85 61 30 ext +33 justine.bacchetta@chu-lyon.fr
Contact: Sacha FLAMMIER, PHD 4 27 85 66 69 ext +33 sacha.flammier@chu-lyon.fr

Locations
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France
Service de Néphrologie, Rhumatologie et Dermatologie Pédiatriques - Hôpital Femme Mère Enfant Recruiting
Bron, France
Contact: Justine BACCHETTA, MD    4 27 85 61 30 ext +33    justine.bacchetta@chu-lyon.fr   
Sponsors and Collaborators
Hospices Civils de Lyon
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT04126941    
Other Study ID Numbers: 2019 FOR-HYPO
First Posted: October 15, 2019    Key Record Dates
Last Update Posted: October 15, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospices Civils de Lyon:
Hypoparathyroidism
Teriparatide
Additional relevant MeSH terms:
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Hypoparathyroidism
Parathyroid Diseases
Endocrine System Diseases
Calcium
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs