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

University of Rostock

Status and phase: Unknown; Phase 1

Conditions: Growth Disorders; Somatropin Therapy; Hypophosphatemic Rickets

Treatments: Drug: somatropin

Study type: Interventional

Funder types: Other

Identifiers

NCT00473187

UKJ-Haffner-XLHR-08-2004

Details and patient eligibility

About

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.

Sex: All

Ages: 3 to 10 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)