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Completed

NCT Number: NCT00355030

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

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.

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Key information

Conditions

Idiopathic Short Stature (ISS)

Age range

8 year–171 month

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., Amiens, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • male or female children with ISS
  • age greater than or equal to 8 years and less than or equal to 12 years and 3 months for girls and greater than or equal to 9 years and less than or equal to 14 years and 3 months for boys
  • bone age less than or equal to 12.0 years for girls and less than or equal to 14.0 years for boys based on a central reading of an X-ray of the left hand and wrist
  • Pubertal stage B2 and B3 for girls based on the Tanner method
  • Pubertal stage G2 and G3 for boys based on the Tanner method

Exclusion criteria

  • Growth hormone deficiency (GHD)
  • Insulin-like growth factor-I levels greater than 3 SDS
  • Chromosomal abnormality diagnosed locally on a karyotype. For girls, the karyotype to eliminate a Turner syndrome, is mandatory
  • Small for gestational age (SGA)
  • Has reached menarche (had her first menstrual period)
  • Have any significant concomitant disease that is likely to interfere with growth or with the study, or is a known contraindication to Growth Hormone treatment

Treatment and study plan

Somatropin

Drug

0.05 mg/kg/day

Other names: LY137998, Humatrope

leuprorelin

Drug

11.25 mg/3 months

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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)

  7. 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.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Acronym: Phoenix

Important dates

Study start
2006
Primary completion
2015
Study completion
2015
First posted
Jul 20, 2006
Registry last updated
Sep 30, 2019

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.