Monocentric Study on the Use of Teriparatide in Children... | NCT04126941

Studies
Monocentric Study on the Use of Teriparatide in Children With hypoparathyroïdism

NCT04126941

Sponsor

Hospices Civils de Lyon

Status

Unknown status

Last Update Posted

Oct 15, 2019Actual

Enrollment

9Estimated

Phase

Not provided

Conditions

Hypoparathyroidism

Interventions

Serum calcium concentrations results

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2019Actual

Primary Completion Date

Jun 2020Estimated

Completion Date

Dec 2020Estimated

First Submitted Date

Oct 11, 2019

First Submission Date that Met QC Criteria

Oct 11, 2019

First Posted Date

Oct 15, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 11, 2019

Last Update Posted Date

Oct 15, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

9Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Teriparatide		Patients with hypoparathyroidism treated by teriparatide	Other: Serum calcium concentrations results

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Serum calcium concentrations results	Other	To compare serum calcium concentrations results in patients with hypoparathyroidism before and three months after initiation of teriparatide therapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Serum calcium concentration		3 months after treatment initiation

Secondary Outcomes

Measure	Description	Time Frame
Serum calcium concentration		1 month after treatment initiation
Serum calcium concentration		6 months after treatment initiation
Serum calcium concentration

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Patients with hypoPTH (Hypoparathyroidism) treated with teriparatide

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Justine BACCHETTA, MD	Contact	4 27 85 61 30	+33	justine.bacchetta@chu-lyon.fr
Sacha FLAMMIER, PHD	Contact	4 27 85 66 69	+33	sacha.flammier@chu-lyon.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service de Néphrologie, Rhumatologie et Dermatologie Pédiatriques - Hôpital Femme Mère Enfant	Recruiting	Bron			France

Condition Browse Module

MeSH Terms

ID	Term
D007011	Hypoparathyroidism

Ancestor Terms

ID	Term
D010279	Parathyroid Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided