Somatropin Treatment in Patients With SHOX Deficiency and Turner Syndrome

Phase 3CompletedNCT00190658

Eli Lilly and Company75 enrolled

Overview

This clinical trial will compare the mean first year height velocity of somatropin-treated prepubertal patients with SHOX deficiency with the height velocity of a control group of untreated prepubertal patients with SHOX deficiency. Both groups will be compared to a somatropin-treated group of girls with Turner syndrome. After the second year patients in the control group have the option to receive treatment as well. All patients will optionally be treated until they achieved adult height.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Failure to Thrive

Interventions

Somatropin (rDNA origin) for injectionDRUG

Eligibility

Sex: ALLMin age: 3 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Turner Syndrome or SHOX disorder * SHOX: bone age greater than 10 years for boys, greater than 8 years for girls, Turner: bone age greater than 9 years * Height below 3rd percentile or height below 10th percentile and growth velocity below 25th percentile * Prepubertal: For girls, Tanner stage 1, for boys Tanner stage 1 and testicular volume no more than 2 mL Exclusion Criteria: * GH deficiency or known insensitivity * Evidence of tumor activity * Diabetes mellitus or history of impaired glucose tolerance * Any severe illness known to interfere growth

Locations (1)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

Comparison of first year height velocity of somatropin-treated versus non-treated patients with SHOX deficiency.

Secondary Outcomes

Comparison of second year height velocity of somatropin-treated versus non-treated patients with SHOX deficiency.

Non inferiority to somatropin treated patients with Turner syndrome

Adult height of treated patients

Data from ClinicalTrials.gov

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