Growth Hormone Treatment in Children With Hypophosphatemic Rickets (GH-XLH)

Bicetre Hospital

Status and phase: Completed; Phase 2; Phase 1

Conditions: X Linked Hypophosphatemic Rickets

Treatments: Drug: norditropine simplex

Study type: Interventional

Funder types: Other

Identifiers

NCT02720770

RBM 03-47

Details and patient eligibility

About

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

Enrollment: 19 patients

Sex: All

Ages: 3 to 14 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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19 participants in 1 patient group

norditropine simplex

Experimental group

Treatment:

Drug: norditropine simplex