Growth Hormone Treatment in Children With Hypophosphatemic Rickets

NCT ID: NCT02720770

Last Updated: 2016-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2011-01-31

Brief Summary

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This study evaluates the effect on height of a two year treatment with growth hormone in 19 children with X linked hypophosphatemic rickets.

Detailed Description

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Conditions

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X Linked Hypophosphatemic Rickets

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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norditropine simplex

Group Type EXPERIMENTAL

norditropine simplex

Intervention Type DRUG

Interventions

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norditropine simplex

Intervention Type DRUG

Other Intervention Names

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growth hormone

Eligibility Criteria

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Inclusion Criteria

* clinical, biochemical and genetic diagnosis of XLH
* height SDS \< 2
* at least two years of treatment with oral phosphate and calcitriol

Exclusion Criteria

* uncontrolled rickets (ALP\>600 IU)
* growth hormone deficiency
* hyperparathyroidism, nephrocalcinosis, renal insufficiency
* associated disease
* previous treatment with growth hormone
Minimum Eligible Age

3 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bicetre Hospital

OTHER

Sponsor Role lead

Responsible Party

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Alessia Usardi

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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Rothenbuhler A, Esterle L, Gueorguieva I, Salles JP, Mignot B, Colle M, Linglart A. Two-year recombinant human growth hormone (rhGH) treatment is more effective in pre-pubertal compared to pubertal short children with X-linked hypophosphatemic rickets (XLHR). Growth Horm IGF Res. 2017 Oct;36:11-15. doi: 10.1016/j.ghir.2017.08.001. Epub 2017 Aug 15.

Reference Type DERIVED
PMID: 28822957 (View on PubMed)

Other Identifiers

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RBM 03-47

Identifier Type: -

Identifier Source: org_study_id

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