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Growth Hormone Treatment for the Prevention of Short Stature in Young Girls With Turner Syndrome Before the Age of 4 Years

NCT ID: NCT01066052

Last Updated: 2018-12-14

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

115 participants

Study Classification

INTERVENTIONAL

Study Start Date

1992-02-29

Study Completion Date

2010-08-31

Brief Summary

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The objective of this study is to evaluate the efficacy and safety of recombinant human growth hormone (r-hGH) treatment in girls with Turner Syndrome under the age of 4 years. After 4 years of treatment, height in these girls will be compared with an historical control group of untreated girls with Turner Syndrome, matched for age and height at baseline.

Detailed Description

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Conditions

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Turner's Syndrome

Keywords

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Growth hormone Turner syndrome r-hGH early treatment

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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r-hGH

Participants (girls) will receive r-hGH as a subcutaneous injection administered by a parent in the evening. During Years 1-2, the dose of r-hGH received will depend on participants' baseline height standard deviation score (SDS) relative to the general population standard: participants with a height SDS of -2 standard deviation (SD) or lower will receive 0.05 milligrams per kilogram (mg/kg) per day r-hGH and those with a height SDS between -1 and -2 SD will receive 0.035 mg/kg per day r-hGH. After 2 years of treatment, all participants will receive a fixed dose of 0.05 mg/kg per day for a further 2 years.

Group Type EXPERIMENTAL

r-hGH

Intervention Type DRUG

Subcutaneous administration.

Historical Control

This arm will include matching (age and height) historical control participants (girls) with turner syndrome, who were born between 1961 and 1990 and were untreated.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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r-hGH

Subcutaneous administration.

Intervention Type DRUG

Other Intervention Names

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Saizen®

Eligibility Criteria

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Inclusion Criteria

* Young girls with turner syndrome proved by karyotype
* Growth hormone secretion confirmed with ornithin stimulation test
* Normal glucidic metabolism confirmed by assessment of HbA1c
* None associated severe pathology which could have impact on growth (i.e. renal insufficiency, decompensated heart failure)
* No previous or associated treatment with anabolic or sexual steroids
* Known parental height

Exclusion Criteria

* Severe associated pathology with impact on growth
* Concomitant treatment with impact on growth
* Previous or associated treatment with anabolic steroids
* Associated growth hormone deficiency
Maximum Eligible Age

4 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Merck KGaA, Darmstadt, Germany

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Responsible

Role: STUDY_DIRECTOR

Merck KGaA, Darmstadt, Germany

Locations

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Hôpital Robert Debré

Paris, , France

Site Status

Countries

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France

References

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Linglart A, Cabrol S, Berlier P, Stuckens C, Wagner K, de Kerdanet M, Limoni C, Carel JC, Chaussain JL; French Collaborative Young Turner Study Group. Growth hormone treatment before the age of 4 years prevents short stature in young girls with Turner syndrome. Eur J Endocrinol. 2011 Jun;164(6):891-7. doi: 10.1530/EJE-10-1048. Epub 2011 Mar 11.

Reference Type RESULT
PMID: 21398400 (View on PubMed)

Other Identifiers

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GF 5834

Identifier Type: -

Identifier Source: org_study_id