Clinical Trial: Somatropin + Leuprorelin vs Somatropin Alone in Pubertal Children With Idiopathic Short Stature

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Efficacy and Safety of Somatropin in Combination With Leuprorelin Compared to Somatropin Alone in Pubertal Children With Idiopathic Short Stature

Brief Summary:

The present randomized trial was initially intended to study the benefits of a combined treatment with growth hormone (GH) and a gonadotropin-releasing hormone (GnRH) agonist for pubertal children with idiopathic short stature. However, treatments were stopped in January 2012 at the request of the French drug agency. Therefore, a protocol amendment divided the study in two study periods.

Study Period 1 involved combined treatment with somatropin and leuprorelin or treatment with somatropin alone. Participants from France who participated in this Period 1 of the study were asked to participate in a long term safety follow up defined as a Period 2 of the study. Participants from the Netherlands were offered participation in Genetics and Neuroendocrinology of Short Stature International Study (GeNeSIS, clinicaltrials.gov Identifier: NCT01088412) for long term safety follow up independent of this study.

Detailed Summary:
Sponsor: Eli Lilly and Company

Current Primary Outcome:

• Number of Participants With One or More Drug-related Adverse Events [ Time Frame: Baseline through End of Study (up to 9 years) ]
  A drug-related AE was an AE that occurred postdose or was present predose and became more severe postdose and was considered to be related to study treatment. A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.
• Adult Height Standard Deviation Score (SDS) [ Time Frame: Baseline through End of Study (up to 9 years) ]
  The height of the participants were measured barefoot using a standard wall-mounted Harpenden stadiometer. SDS report the number of standard deviations from the mean for age and sex for an individual measurement (normal range: -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.

Original Primary Outcome: Adult height reached, expressed in SDS for adult height

Current Secondary Outcome:

• Height Velocity [ Time Frame: Baseline through End of Study (up to 9 years) ]
  Height velocity is the difference between 2 height measurements, divided by years elapsed between measurements.
• Height SDS [ Time Frame: Baseline through End of Study (up to 9 years) ]
  SDS report the number of standard deviations from the mean for age and sex for an individual measurement (normal range: -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.
• Difference Between Adult Height SDS and Target Height SDS [ Time Frame: Baseline through End of Study (up to 9 years) ]

  This is the difference between the gender, age and country matched standard deviation score of adult height and standard deviation score of target height [calculated as (mother's height (SDS) + father's height (SDS))/2] for particular participant.

  The height of the participants were measured barefoot using a standard wall-mounted Harpenden stadiometer. SDS report the number of standard deviations from the mean for age and sex for an individual measurement (normal range: -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.

• Difference Between Adult Height SDS and Baseline Predicted Height SDS [ Time Frame: Baseline through End up Study (up to 9 years) ]

  This is the difference between the gender, age and country matched standard deviation score of adult height and standard deviation score of baseline predicted height [calculated using the Bayley-Pinneau method based on height and bone age] for particular participant.

  The height of the participants were measured barefoot using a standard wall-mounted Harpenden stadiometer. SDS report the number of standard deviations from the mean for age and sex for an individual measurement (normal range: -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.

• Difference Between Adult Height SDS and Baseline Height SDS [ Time Frame: Baseline through End up Study (up to 9 years) ]

  This is the difference between the gender, age and country matched standard deviation score of adult height and standard deviation score of baseline height for particular participant.

  The height of the participants were measured barefoot using a standard wall-mounted Harpenden stadiometer. SDS report the number of standard deviations from the mean for age and sex for an individual measurement (normal range: -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.

• Percentage of Children With Normal Adult Height SDS [ Time Frame: Baseline through End of Study (up to 9 years) ]
  Percentage of children with normal adult height SDS (greater than -2 SDS and less than +2 SDS)
• Bone Age [ Time Frame: Baseline through End of Study (up to 9 years) ]
  Bone age measured using the X-Ray of left hand and wrist.

Original Secondary Outcome:

• Annual height velocities
• Height SDS
• Target heights
• Predicted adult height
• Bone Age
• Bone age delay (deficit)

Dates:
Date Received: July 18, 2006
Date Started: June 2006
Date Completion:
Last Updated: August 24, 2016
Last Verified: August 2016