Effects of GH on Body Proportions and Final Height in X-Linked Hypophosphatemic Rickets

University of Rostock

Overview

X-linked hypophosphatemic rickets (XLH) is characterized by rickets, disproportionate short stature, impaired renal phosphate reabsorption and vitamin D metabolism. Despite oral phosphate and vitamin D treatment, most children with XLH demonstrate reduced adult height. The main objective of the study is to determine the beneficial effects of recombinant human growth hormone (rhGH) therapy on body proportions after 36 month in these patients. Secondary objective is to monitor side effects of the therapy.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Hypophosphatemic Rickets Growth Disorders Somatropin Therapy

Interventions

somatropinDRUG

Eligibility

Sex: ALLMin age: 3 YearsMax age: 10 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Tanner stages of puberty B1, G1 * body height \< 2,5 SDS * growth velocity \< 75% * confirmed diagnosis of XLHR * conservative treatment for at least 1 year (phosphate, vitamin D) * informed consent, written agreement Exclusion Criteria: * growth hormone deficiency * hypothyreosis * severe rickets * severe physical deformities * severe hyperparathyreoidism * chronic renal failure * complex syndrome involving failure to thrive * chronic disease with failure to thrive * impairment of glucose tolerance * Tanner stages of puberty greater than B1, G1 * medical history of malignancy * therapy with growth hormone, glucocorticoides, anabolica * attending another clinical trial

Locations (1)

University Childrens Hospital, Rostock

Rostock, Mecklenburg-Vorpommern, Germany

Outcomes

Primary Outcomes

change of body proportion and final height

Time frame: within 5 years

Secondary Outcomes

side effects of therapy with rhGH

Time frame: within 5 years

Data from ClinicalTrials.gov

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