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Somatropin Treatment in Patients With SHOX Deficiency and Turner Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00190658
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : December 20, 2010
Information provided by:

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Failure to Thrive Drug: Somatropin (rDNA origin) for injection Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Humatrope in Pediatric Patients With Genetic Short Stature (SHOX Gene Defect)
Study Start Date : February 2000
Primary Completion Date : July 2004
Study Completion Date : September 2010

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. Comparison of first year height velocity of somatropin-treated versus non-treated patients with SHOX deficiency.

Secondary Outcome Measures :
  1. Comparison of second year height velocity of somatropin-treated versus non-treated patients with SHOX deficiency.
  2. Non inferiority to somatropin treated patients with Turner syndrome
  3. Adult height of treated patients

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00190658

United States, Pennsylvania
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
Sponsors and Collaborators
Eli Lilly and Company
Study Chair: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00190658     History of Changes
Other Study ID Numbers: 2704
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: December 20, 2010
Last Verified: December 2010

Additional relevant MeSH terms:
Failure to Thrive
Signs and Symptoms