Effects of GH on Body Proportions and Final Height in X-Linked Hypophosphatemic Rickets
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| ClinicalTrials.gov Identifier: NCT00473187 |
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Recruitment Status : Unknown
Verified May 2007 by University of Rostock.
Recruitment status was: Active, not recruiting
First Posted : May 14, 2007
Last Update Posted : May 14, 2007
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Sponsor:
University of Rostock
Information provided by:
University of Rostock
| Tracking Information | ||||||||||
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| First Submitted Date ICMJE | May 11, 2007 | |||||||||
| First Posted Date ICMJE | May 14, 2007 | |||||||||
| Last Update Posted Date | May 14, 2007 | |||||||||
| Study Start Date ICMJE | August 2004 | |||||||||
| Primary Completion Date | Not Provided | |||||||||
| Current Primary Outcome Measures ICMJE |
change of body proportion and final height [ Time Frame: within 5 years ] | |||||||||
| Original Primary Outcome Measures ICMJE | Same as current | |||||||||
| Change History | No Changes Posted | |||||||||
| Current Secondary Outcome Measures ICMJE |
side effects of therapy with rhGH [ Time Frame: within 5 years ] | |||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | |||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Descriptive Information | ||||||||||
| Brief Title ICMJE | Effects of GH on Body Proportions and Final Height in X-Linked Hypophosphatemic Rickets | |||||||||
| Official Title ICMJE | Effects of Growth Hormone Treatment on Body Proportions and Final Height Among Small Children With X-Linked Hypophosphatemic Rickets | |||||||||
| 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 Provided | |||||||||
| Study Type ICMJE | Interventional | |||||||||
| Study Phase ICMJE | Phase 1 | |||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Drug: somatropin | |||||||||
| Study Arms ICMJE | Not Provided | |||||||||
| Publications * | Not Provided | |||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||||||||
| Recruitment Status ICMJE | Unknown status | |||||||||
| Enrollment ICMJE | Not Provided | |||||||||
| Original Enrollment ICMJE | Not Provided | |||||||||
| Estimated Study Completion Date ICMJE | August 2009 | |||||||||
| Primary Completion Date | Not Provided | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 3 Years to 10 Years (Child) | |||||||||
| Accepts Healthy Volunteers ICMJE | No | |||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||||||||
| Listed Location Countries ICMJE | Germany | |||||||||
| Removed Location Countries | ||||||||||
| Administrative Information | ||||||||||
| NCT Number ICMJE | NCT00473187 | |||||||||
| Other Study ID Numbers ICMJE | UKJ-Haffner-XLHR-08-2004 | |||||||||
| Has Data Monitoring Committee | Not Provided | |||||||||
| U.S. FDA-regulated Product | Not Provided | |||||||||
| IPD Sharing Statement ICMJE | Not Provided | |||||||||
| Current Responsible Party | Not Provided | |||||||||
| Original Responsible Party | Same as current | |||||||||
| Current Study Sponsor ICMJE | University of Rostock | |||||||||
| Original Study Sponsor ICMJE | Same as current | |||||||||
| Collaborators ICMJE | Not Provided | |||||||||
| Investigators ICMJE |
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| PRS Account | University of Rostock | |||||||||
| Verification Date | May 2007 | |||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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