Growth Hormone Treatment in Children With Hypophosphatemic Rickets

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

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Key information

Conditions

X Linked Hypophosphatemic Rickets Avitaminosis Bone Diseases Bone Diseases, Metabolic Calcium Metabolism Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Deficiency Diseases Familial Hypophosphatemic Rickets Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genetic Diseases, Inborn Hypophosphatemia Hypophosphatemia, Familial Kidney Diseases Male Urogenital Diseases Malnutrition Metabolic Diseases Metabolism, Inborn Errors Metal Metabolism, Inborn Errors Musculoskeletal Diseases Nutrition Disorders Nutritional and Metabolic Diseases Phosphorus Metabolism Disorders Renal Tubular Transport, Inborn Errors Rickets Rickets, Hypophosphatemic Urogenital Diseases Urologic Diseases Vitamin D Deficiency

Age range

3 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

norditropine simplex

Drug

Other names: growth hormone

Primary outcomes

change from baseline in height SDS (standard deviation score)

Time frame: at year one and year two from baseline

Sponsors and collaborators

Lead sponsor

Bicetre Hospital

Other

Registry information

Official study title

Proposition Pour un Traitement Par Hormone de Croissance Des Enfants Atteints de Rachitisme Hypophosphatemique Familial

Acronym: GH-XLH

Important dates

Study start: 2006
Primary completion: 2009
Study completion: 2011
First posted: Mar 28, 2016
Registry last updated: Mar 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed