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

NCT00266656 | Completed Phase 4 Results

• 2 other identifiers: 10088B9R-US-GDGH
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 9

Brief 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.

Conditions

Turner Syndrome

Outcome Measures

Primary Outcomes (1)

• Most Mature Height Standard Deviation Score (SDS)

  SDS reports the number of standard deviations from the mean for age and sex for an individual measurement (normal range is -2 to +2 SDS). Height SDS is derived by subtracting the population mean from individual's height value and then dividing that difference by the population standard deviation. Greater height SDS values indicate greater height.

  Baseline through End of Study (10 years)

Secondary Outcomes (8)

• Height SDS at Various Ages

  Age 10, Age 13, Age 16

• Age at Attainment of Tanner 2 Breast Development

  Baseline through End of Study (10 years)

• Chronological Age at First Visit Participant Attained Bone Age of 14.5 Years

  Baseline through End of Study (10 years)

• Reports of Serious Adverse Events

  Baseline through End of Study (10 years)

• Percentage of Participants With Occurrence of Pre-specified Clinically Relevant Events

  Baseline through End of Study (10 years)

Study Arms (2)

Experimental 1 Control

EXPERIMENTAL

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.

Drug: Humatrope

Experimental 2 Humatrope

EXPERIMENTAL

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

Drug: Humatrope

Interventions

Humatrope DRUG

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

Also known as: LY137998, Somatropin, Growth hormone

Experimental 1 Control; Experimental 2 Humatrope

Eligibility Criteria

• Age: 4 Years - 20 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (9)

Childrens Hospital of Los Angeles

Los Angeles, California, 90027, United States

Location

Children's Hospital

Aurora, Colorado, 80045, United States

Location

Connecticut Children's Medical Center

Hartford, Connecticut, 06106, United States

Location

Children's Hospital of Chicago Research Center

Chicago, Illinois, 60611, United States

Location

Riley Hosptial for Children

Indianapolis, Indiana, 46202, United States

Location

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

University of NC at Chapel Hill School of Medicine

Chapel Hill, North Carolina, 27514, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Childrens Hospital and Medical Center

Seattle, Washington, 98105, United States

Location

Related Links

• Lilly Clinical Trial Registry

MeSH Terms

Conditions

Turner Syndrome

Interventions

Human Growth Hormone; Growth Hormone

Condition Hierarchy (Ancestors)

Gonadal Dysgenesis; Disorders of Sex Development; Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Sex Chromosome Disorders of Sex Development; Male Urogenital Diseases; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Sex Chromosome Disorders; Chromosome Disorders; Genetic Diseases, Inborn; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5979

Study Officials

• 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2005
• First Posted: December 19, 2005
• Study Start: December 1, 2005
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: March 31, 2017
• Results First Posted: August 23, 2016

Record last verified: 2017-03

Locations

US (9)