Effects of GH on Body Proportions and Final Height in X-Linked Hypophosphatemic Rickets
Phase 1
- Conditions
- Hypophosphatemic RicketsGrowth DisordersSomatropin Therapy
- Registration Number
- NCT00473187
- Lead Sponsor
- University of Rostock
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- Not specified
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method change of body proportion and final height within 5 years
- Secondary Outcome Measures
Name Time Method side effects of therapy with rhGH within 5 years
Trial Locations
- Locations (1)
University Childrens Hospital, Rostock
🇩🇪Rostock, MV, Germany