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NCT00266656 Clinical Trial

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

Turner Syndrome Clinical Trial

Official title:
Effect of Early Growth Hormone Treatment on Long-term Growth and Skeletal Maturation in Girls With Turner Syndrome

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00266656
Other study ID # 10088
Secondary ID B9R-US-GDGH
Status Completed
Phase Phase 4
First received December 15, 2005
Last updated September 24, 2015
Start date December 2005
Est. completion date September 2015

Study information
Verified date September 2015
Source Eli Lilly and Company
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 69
Est. completion date September 2015
Est. primary completion date September 2015
Accepts healthy volunteers No
Gender Female
Age group 4 Years to 20 Years
Eligibility Inclusion Criteria:

- Previously randomized in study B9R-US-GDFG

- Karyotype-proven Turner syndrome

Exclusion Criteria:

- Immediate family members of study site personnel directly affiliated with the study

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Somatropin
According to investigator's clinical practice and guided by the approved package insert

Locations
Country Name City State
United States Children's Hospital Aurora Colorado
United States University of NC at Chapel Hill School of Medicine Chapel Hill North Carolina
United States Children's Hospital of Chicago Research Center Chicago Illinois
United States Connecticut Children's Medical Center Hartford Connecticut
United States Riley Hosptial for Children Indianapolis Indiana
United States Children's Mercy Hospital Kansas City Missouri
United States Childrens Hospital of Los Angeles Los Angeles California
United States Thomas Jefferson University Philadelphia Pennsylvania
United States Childrens Hospital and Medical Center Seattle Washington

Sponsors (1)
Lead Sponsor Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Adult height at the end of growth. Protocol completion No
Secondary Height SDS at various ages. Over course of the study No
Secondary Age at attainment of Tanner 2 breast development. Over course of the study No
Secondary Chronological age at first visit subject attained bone age of 14.5 years Protocol completion No
Secondary Reports of serious adverse events. Over course of the study Yes
Secondary Occurrence of pre-specified clinically relevant events. Over course of the study Yes
Secondary Tympanometry and audiometry results for assessment of middle ear function and hearing. Over course of the study Yes
See also
  Status Clinical Trial Phase
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Completed NCT01419249 - First Year Growth Response Associated Genetic Markers Validation Phase IV Open-label Study in Growth Hormone Deficient and Turner Syndrome Pre-pubertal Children: the PREDICT Pharmacogenetics Validation Study Phase 4
Completed NCT01518036 - Use of Somatropin in Turner Syndrome Phase 3
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Completed NCT01563926 - Evaluating Acceptance of New Liquid Somatropin Formulation in Children With Growth Hormone Deficiency Phase 3
Completed NCT02787486 - Expanded Noninvasive Genomic Medical Assessment: The Enigma Study
Completed NCT00877942 - Sex Differences in Early Brain Development; Brain Development in Turner Syndrome N/A
Completed NCT00825617 - Quantitative Liver Functions in Turner Syndrome With and Without Hormone Replacement Therapy N/A
Recruiting NCT04463316 - GROWing Up With Rare GENEtic Syndromes
Enrolling by invitation NCT03836300 - Parent and Infant Inter(X)Action Intervention (PIXI) N/A
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Completed NCT01322165 - National Registry of Genetically Triggered Thoracic Aortic Aneurysms and Cardiovascular Conditions N/A
Terminated NCT00419107 - Beta Cell Function in Women With Turner Syndrome N/A
Active, not recruiting NCT00625001 - Long Term Follow-up of Bone Mineral Density in Hormone Treated Turner Syndrome N/A
Completed NCT00029159 - The Effect of Androgen and Growth Hormone on Height and Learning in Girls With Turner Syndrome Phase 3
Completed NCT01518062 - Safety of Somatropin and Induction of Puberty With 17-beta-oestradiol in Girls With Turner Syndrome Phase 4
Completed NCT00471731 - Dry Eye in Women With Turner Syndrome and Women With Premature Ovarian Failure N/A
Completed NCT00256126 - Predictive Markers in Growth Hormone Deficiency (GHD) and Turner Syndrome (TS) Children Treated With SAIZEN® Phase 4
Completed NCT03181230 - Health, Fitness, and Quality of Life in Adolescent Girls With Turner Syndrome

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