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Long-Term Growth and Skeletal Effects of Early Growth Hormone Treatment in Turner Syndrome

NCT ID: NCT00266656

Last Updated: 2017-03-31

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Study Completion Date

2015-09-30

Brief Summary

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This is an extension study that will gather long-term data on the effect of early growth hormone (GH) treatment on adult height and other aspects of health and development in girls with Turner syndrome. The main purpose is to determine whether girls who received 2 years of GH treatment before 6 years of age achieve taller adult height than girls who were untreated during this time. The study will also look at middle ear and hearing function, and cognitive and behavioral development. Protocol completion is defined as attainment of height velocity less than or equal to 1.0 cm/year, or bone age greater than or equal to 15 years.

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Detailed Description

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Conditions

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Turner Syndrome

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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Experimental 1 Control

No drug administration in B9R-US-GDFG (NCT00406926).

Humatrope according to investigator's clinical practice and guided by the approved package insert on whether treatment is given.

Group Type EXPERIMENTAL

Humatrope

Intervention Type DRUG

According to investigator's clinical practice and guided by the approved package insert

Experimental 2 Humatrope

Humatrope according to investigator's clinical practice and guided by the approved package insert on whether treatment is given.

Group Type EXPERIMENTAL

Humatrope

Intervention Type DRUG

According to investigator's clinical practice and guided by the approved package insert

Interventions

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Humatrope

According to investigator's clinical practice and guided by the approved package insert

Intervention Type DRUG

Other Intervention Names

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LY137998 Somatropin Growth hormone

Eligibility Criteria

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Inclusion Criteria

* Previously randomized in study B9R-US-GDFG (NCT00406926)
* Karyotype-proven Turner syndrome

Exclusion Criteria

* Immediate family members of study site personnel directly affiliated with the study
Minimum Eligible Age

4 Years

Maximum Eligible Age

20 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hrs)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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Childrens Hospital of Los Angeles

Los Angeles, California, United States

Site Status

Children's Hospital

Aurora, Colorado, United States

Site Status

Connecticut Children's Medical Center

Hartford, Connecticut, United States

Site Status

Children's Hospital of Chicago Research Center

Chicago, Illinois, United States

Site Status

Riley Hosptial for Children

Indianapolis, Indiana, United States

Site Status

Children's Mercy Hospital

Kansas City, Missouri, United States

Site Status

University of NC at Chapel Hill School of Medicine

Chapel Hill, North Carolina, United States

Site Status

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Site Status

Childrens Hospital and Medical Center

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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B9R-US-GDGH

Identifier Type: OTHER

Identifier Source: secondary_id

10088

Identifier Type: -

Identifier Source: org_study_id

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