Effects of GH on Body Proportions and Final Height in X-Linked Hypophosphatemic Rickets
Primary Purpose
Hypophosphatemic Rickets, Growth Disorders, Somatropin Therapy
Status
Unknown status
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
somatropin
Sponsored by
About this trial
This is an interventional treatment trial for Hypophosphatemic Rickets focused on measuring X-linked dominant hypophosphatemic rickets, growth disorders, anthropometry, human growth hormone
Eligibility Criteria
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
Sites / Locations
- University Childrens Hospital, Rostock
Outcomes
Primary Outcome Measures
change of body proportion and final height
Secondary Outcome Measures
side effects of therapy with rhGH
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00473187
Brief Title
Effects of GH on Body Proportions and Final Height in X-Linked Hypophosphatemic Rickets
Official Title
Effects of Growth Hormone Treatment on Body Proportions and Final Height Among Small Children With X-Linked Hypophosphatemic Rickets
Study Type
Interventional
2. Study Status
Record Verification Date
May 2007
Overall Recruitment Status
Unknown status
Study Start Date
August 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
University of Rostock
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypophosphatemic Rickets, Growth Disorders, Somatropin Therapy
Keywords
X-linked dominant hypophosphatemic rickets, growth disorders, anthropometry, human growth hormone
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
somatropin
Primary Outcome Measure Information:
Title
change of body proportion and final height
Time Frame
within 5 years
Secondary Outcome Measure Information:
Title
side effects of therapy with rhGH
Time Frame
within 5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dirk Schnabel, MD
Organizational Affiliation
University Childrens Hospital - Charite, Berlin
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hagen Staude
Organizational Affiliation
University Childrens Hospital, Rostock
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dieter Haffner, MD
Organizational Affiliation
University Childrens Hospital, Rostock
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Childrens Hospital, Rostock
City
Rostock
State/Province
MV
ZIP/Postal Code
18055
Country
Germany
12. IPD Sharing Statement
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Effects of GH on Body Proportions and Final Height in X-Linked Hypophosphatemic Rickets
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