Overview

This trial is active, not recruiting.

Conditions hypophosphatemic rickets, growth disorders, somatropin therapy
Treatment somatropin
Phase phase 1
Sponsor University of Rostock
Start date August 2004
End date August 2009
Trial identifier NCT00473187, UKJ-Haffner-XLHR-08-2004

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Measure
change of body proportion and final height
time frame: within 5 years

Secondary Outcomes

Measure
side effects of therapy with rhGH
time frame: within 5 years

Eligibility Criteria

Male or female participants from 3 years up to 10 years old.

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

Additional Information

Official title Effects of Growth Hormone Treatment on Body Proportions and Final Height Among Small Children With X-Linked Hypophosphatemic Rickets
Principal investigator Dirk Schnabel, MD
Trial information was received from ClinicalTrials.gov and was last updated in May 2007.
Information provided to ClinicalTrials.gov by University of Rostock.