Effects of GH on Body Proportions and Final Height in X-L... | NCT00473187

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

NCT00473187

Sponsor

University of Rostock

Status

Unknown status

Last Update Posted

May 14, 2007Estimated

Enrollment

Not provided

Phase

Phase 1

Conditions

Hypophosphatemic Rickets
Growth Disorders
Somatropin Therapy

Interventions

somatropin

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2007

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2004

Primary Completion Date

Not provided

Completion Date

Aug 2009Estimated

First Submitted Date

May 11, 2007

First Submission Date that Met QC Criteria

May 11, 2007

First Posted Date

May 14, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 11, 2007

Last Update Posted Date

May 14, 2007Estimated

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
somatropin	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
change of body proportion and final height		within 5 years

Secondary Outcomes

Measure	Description	Time Frame
side effects of therapy with rhGH		within 5 years

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

10 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Childrens Hospital, Rostock		Rostock	Mecklenburg-Vorpommern	18055	Germany

Condition Browse Module

MeSH Terms

ID	Term
D063730	Rickets, Hypophosphatemic
D006130	Growth Disorders
D053098	Familial Hypophosphatemic Rickets

Ancestor Terms

ID	Term
D012279	Rickets
D001851	Bone Diseases, Metabolic
D001847	Bone Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019382	Human Growth Hormone

Ancestor Terms

ID	Term
D013006	Growth Hormone
D010908	Pituitary Hormones, Anterior
D010907	Pituitary Hormones
D036361	Peptide Hormones

Browse Leaves

Not provided

Browse Branches

Not provided