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

Sponsor

University of Rostock (Other)

Overall Status

Unknown status

CT.gov ID

NCT00473187

Collaborator

(none)

Location

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypophosphatemic Rickets Growth Disorders Somatropin Therapy	Drug: somatropin	Phase 1

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Effects of Growth Hormone Treatment on Body Proportions and Final Height Among Small Children With X-Linked Hypophosphatemic Rickets

Study Start Date :

Aug 1, 2004

Anticipated Study Completion Date :

Aug 1, 2009

Outcome Measures

Primary Outcome Measures

change of body proportion and final height [within 5 years]

Secondary Outcome Measures

side effects of therapy with rhGH [within 5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Years to 10 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Childrens Hospital, Rostock	Rostock	MV	Germany	18055

Sponsors and Collaborators

University of Rostock

Investigators

Principal Investigator: Dirk Schnabel, MD, University Childrens Hospital - Charite, Berlin
Principal Investigator: Hagen Staude, University Childrens Hospital, Rostock
Principal Investigator: Dieter Haffner, MD, University Childrens Hospital, Rostock