Frequency and mechanisms of resistance to IGF-1 generation in non-GH deficient short children with low IGF-1 concentration - IGF-1 generation protocol

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-012089-30-BE

Enrollment

Registered

2009-05-12

Start date

2010-03-19

Completion date

Unknown

Last updated

2024-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prepubertal children with stature < -2 SDS, IGF-1 < the lowest reference limit and normal growth hormone response to an ITT or glucagon test MedDRA version: 9.1 Level: LLT Classification code 10040600 Term: Short stature

Interventions

Trade Name: Nutropin AQ Product Name: Nutropin AQ Pharmaceutical Form: Solution for injection Other descriptive name: Somatotropin (rDNA) origin Concentration unit: mg/ml milligram(s)/millilitre Conce

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Prepubertal Children Stature =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Acute illness at the moment of testing Any chronic disease interfering with growth

Design outcomes

Primary

Measure	Time frame
Main Objective: What is the percentage of short prepubertal children with low baseline IGF-1 concentrations having discordant (low IGF-1 (delta 400 ng/ml) response to a standardized high dose and long course IGF Generation Test ?;Secondary Objective: Are the nutritional intake, body fat content and insulin secretion and bone turn-over lower in short children with discordant IGF Generation Test compared to those with a normal IGF Generation Test ? Is the first year growth response to GH therapy in short ISS children qualifying for GH treatment lower in those with a discordant response compared to those with a normal IGF Generation Test ? Is the change in bone turn-over markers (ostase & ß-crosslinks) after one week of GH administration predictive for the first year response to GH therapy ?;Primary end point(s): Number of patients with low baseline IGF-1 ( 400 ng/ml) at the end of day 7 of the IGF Generation Test.	—

Measure

Time frame

Main Objective: What is the percentage of short prepubertal children with low baseline IGF-1 concentrations having discordant (low IGF-1 (delta 400 ng/ml) response to a standardized high dose and long course IGF Generation Test ?;Secondary Objective: Are the nutritional intake, body fat content and insulin secretion and bone turn-over lower in short children with discordant IGF Generation Test compared to those with a normal IGF Generation Test ? Is the first year growth response to GH therapy in short ISS children qualifying for GH treatment lower in those with a discordant response compared to those with a normal IGF Generation Test ? Is the change in bone turn-over markers (ostase & ß-crosslinks) after one week of GH administration predictive for the first year response to GH therapy ?;Primary end point(s): Number of patients with low baseline IGF-1 ( 400 ng/ml) at the end of day 7 of the IGF Generation Test.

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Countries

Belgium

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026