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

NCT ID: NCT00473187

Last Updated: 2007-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2004-08-31

Study Completion Date

2009-08-31

Brief Summary

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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

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Conditions

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Hypophosphatemic Rickets Growth Disorders Somatropin Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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somatropin

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

3 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Rostock

OTHER

Sponsor Role lead

Principal Investigators

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Dirk Schnabel, MD

Role: PRINCIPAL_INVESTIGATOR

University Childrens Hospital - Charite, Berlin

Hagen Staude

Role: PRINCIPAL_INVESTIGATOR

University Childrens Hospital, Rostock

Dieter Haffner, MD

Role: PRINCIPAL_INVESTIGATOR

University Childrens Hospital, Rostock

Locations

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University Childrens Hospital, Rostock

Rostock, Mecklenburg-Vorpommern, Germany

Site Status

Countries

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Germany

Other Identifiers

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UKJ-Haffner-XLHR-08-2004

Identifier Type: -

Identifier Source: org_study_id