Growth Disorders, Hypophosphatemic Rickets, Somatropin Therapy
Conditions
Keywords
X-linked dominant hypophosphatemic rickets, growth disorders, anthropometry, human growth hormone
Brief summary
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.
Interventions
DRUGsomatropin
Sponsors
University of Rostock
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 10 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change of body proportion and final height | within 5 years |
Secondary
| Measure | Time frame |
|---|---|
| side effects of therapy with rhGH | within 5 years |
Countries
Germany
Outcome results
None listed