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OpenTrials
Completed

NCT Number: NCT00396097

Individualized, Target-Driven Treatment Of Children With Idiopathic Short Stature

To demonstrate that an individualized, formula-based Genotropin regimen for children with Idiopathic Short Stature will lead to a targeted height gain (to reach the target of 10th percentile (%), or -1.3 SDS) during 24 months of treatment. The endpoint at 4 years is to explore treatment efficiency over four years of two formula-based dose regimens (sub-arms) compared to standard treatment

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Key information

Conditions

Idiopathic Short Stature

Age range

3 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Arkansas Children's Hospital, Little Rock, Alaska, United States

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Prepubertal children with bone ages between 3 and 10 years of age for males and 3 and 9 years of age for females
  • Naive to Growth Hormone treatment

Exclusion criteria

  • Abnormal karyotype. Small Gestational Age and Skeletal dysplasia.

Treatment and study plan

Genotropin

Drug

Compare daily injections of formula-based HGH treatment to daily injections of standard HGH treatment in subjects with Idiopathic Short Stature over 24 months period followed by an exploratory 24 months period.

Primary outcomes

  1. Absolute On-target Difference (AOTD) at 24 Months

    Time frame: 2 years

    This was defined as an absolute difference between the 24-month height standard deviation score (SDS) and targeted 24-month height SDS (10th percentile (%), or -1.3 SDS). SDS indicates how similar the participant was to the reference population. These were calculated using 2000 Center for the Disease Control (CDC) growth reference tables (by age and gender).

Secondary outcomes

  1. Variability of Height SDS at 24 Months

    Time frame: 2 years

    The continuous endpoint of variability of height SDS at 24 months was defined as the SD of the 24 month height SDS.

  2. Time Cost (Months Until >= -2 SDS)

    Time frame: 2 years

    Time cost was defined as the number of months needed until height SDS was within the normal limit (ie, >= -2SDS).

  3. Computed Cost of Height Gain at 48 Months

    Time frame: 4 years

    The computed cost of height gain was defined as the amount of drug used relative to the observed height-gain, in terms of mg/cm, this was calculated at Month 48.

  4. Estimated Cost of Height Gain Estimated Until Full Adult Height (FAH) at 48 Months

    Time frame: 4 years

    The estimated cost of long-term height gain until FAH was calculated.

  5. Change From Baseline in Height SDS at 48 Months.

    Time frame: 4 years

    Change in height SDS was measured at 48 months.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Four Year Open Label Multi Center Randomized Two Arm Study Of Genotropin In Idiopathic Short Stature Patients: Comparing An Individualized, Target Driven Treatment Regimen To Standard Dosing Of Genotropin

Important dates

Study start
2006
Primary completion
2012
Study completion
2012
First posted
Nov 6, 2006
Registry last updated
Apr 5, 2016

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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