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OpenTrials
Completed

NCT Number: NCT00190658

Somatropin Treatment in Patients With SHOX Deficiency and Turner Syndrome

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.

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Key information

Conditions

Failure to Thrive Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

3 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Somatropin (rDNA origin) for injection

Drug

Primary outcomes

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

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

Safety and Efficacy of Humatrope in Pediatric Patients With Genetic Short Stature (SHOX Gene Defect)

Important dates

Study start
2000
Primary completion
2004
Study completion
2010
First posted
Sep 19, 2005
Registry last updated
Dec 20, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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