Clinical Trials Logo

Clinical Trial Summary

Children with extreme short stature (height) and their families often experience significant psychological stress related to concerns about adult height. In addition, short stature often results in life-long emotional, social, and physical obstacles to the affected person.

Normal growth occurs in two phases. The first phase, known as childhood growth, occurs below the age of 10. The second phase of growth, teen-age or adolescent growth, begins between the ages of 10 and 15. In addition, puberty marks the time when the bone's growth plates (epiphysis) begin to close, initiating the completion of linear growth (height).

Some children suffer from a condition called precocious puberty, meaning that puberty begins at a younger age than normal. The development of medications known as synthetic LHRH analogs have provided a method to delay puberty and treat these patients.

LHRHa (deslorelin) is a hormone created to act like naturally occurring LHRH. It been used in patient's diagnosed with precocious (early onset) puberty. The drugs were able to regress patient's clinical signs of puberty, decrease the levels of adult sex hormones produced, and slow the rate of bone aging.


Clinical Trial Description

Children with extreme short stature and their families frequently experience significant psychological stress related to concerns about adult height. Additionally, extreme short stature often presents life-long emotional, social, and physical obstacles to the affected individual. The onset of puberty in such patients presents a critical management problem because puberty initiates the process of epiphyseal closure that terminates linear growth. Until recently, there was no way to delay the onset of puberty in such patients. The development of synthetic LHRH analogs, however, has provided such a method. Administration of such analogs to children with precocious puberty caused a regression of their clinical signs of puberty, a decrease in their gonadotropins and sex steroids, and a slowing of the rate of bone age advancement.

We propose to treat pubertal children with extreme short stature with a long-acting analog of luteinizing hormone-releasing hormone (D-Trp6-Pro9-NEt-LHRHa). The goal of LHRHa treatment in these children is to halt the normal progression into puberty and thereby delay epiphyseal fusion. We postulate that delay of puberty will prolong pre-pubertal growth prior to the pubertal spurt and subsequent epiphyseal fusion, and thus will enhance ultimate height. This study will test this hypothesis through a double-blind, randomized comparison of the effect of LHRHa and placebo on final adult height. Patients will be treated with LHRHa or placebo for 4 years, and will then be followed until they have completed puberty and have stopped growing. ;


Study Design

Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00001190
Study type Interventional
Source National Institutes of Health Clinical Center (CC)
Contact
Status Completed
Phase Phase 2
Start date November 1983
Completion date October 2001

See also
  Status Clinical Trial Phase
Completed NCT01943084 - A Trial to Investigate the Bioequivalence of Norditropin® (Somatropin) Versus Genotropin® (Somatropin) in Healthy Adult Subjects Phase 1
Completed NCT02580032 - Validation of Two Measures for Growth Hormone Deficiency in Children, the Treatment Related Impact Measure of Childhood Growth Hormone Deficiency (TRIM-CGHD) and the Treatment Burden Measure of Childhood Growth Hormone Deficiency (TB-CGHD)
Completed NCT01578135 - French National Registry of Children Born Small for Gestational Age Treated With Somatropin
Completed NCT01401244 - Bioequivalence of Two Somatropin Products (Norditropin® Versus Genotropin®) in Healthy Adult Volunteers Phase 1
Recruiting NCT02769975 - Evaluation of Children With Endocrine and Metabolic-Related Conditions
Completed NCT01778023 - Efficacy and Safety of Recombinant Human Growth Hormone on Height Velocity in Subjects With Idiopathic Short Stature Phase 3
Completed NCT01543867 - Safety and Efficacy of Long-term Somatropin Treatment in Children N/A
Completed NCT00191074 - Amendment (g) Unblinded Extension Phase of Somatropin in Patients With Idiopathic Short Stature Phase 3
Terminated NCT02311322 - Genetic Causes of Growth Disorders
Withdrawn NCT01512095 - Bioequivalence of Two Products (Norditropin® Versus Nutropin AQ®) in Healthy Adult Volunteers Phase 1
Completed NCT00262249 - Effect of Growth Hormone in Children With Growth Hormone Deficiency Phase 3
Completed NCT02428296 - Study of Sirolimus Therapy for Segmental Overgrowth Caused by Somatic PI3K Activation Phase 2
Completed NCT00174421 - Treatment Of Short Stature With Genotropin In Children Born Small For Gestational Age Until Final Height Phase 3