Phase 3 N=98 Randomized Treatment

Individualizing Dose of Growth Hormone to Maintain Normal Growth Velocity After Fulfilled Catch up Growth in Children

Short Stature

Bottom Line

View on ClinicalTrials.gov: NCT02879747 ↗

Enrolled (actual)

Serious AEs

10.2%

Results posted

Apr 2019

Primary outcome: Primary: The Proportion of Children Maintaining Normal Growth Velocity — 23; 32; 31 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Genotropin (Drug)
Age: Pediatric, Adult · 4+ yrs
Sex: All
Sponsor: Göteborg University
Primary completion: Mar 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY The Proportion of Children Maintaining Normal Growth Velocity	23; 32; 31	—
SECONDARY IGF-I	-1.10; 0.58; -0.06	—
SECONDARY Height SDS at Start of Puberty	-1.0; -1.06; -0.98	—

Summary

The objective was to study whether normal growth velocity can be maintained with adapted GH dosage in GH treated prepubertal children who have responded to GH treatment with fulfilled catch up growth (=difference to target height reached, less than - 0.6 SDS).

Eligibility Criteria

Inclusion Criteria

Participated in the 'GH-dose catch-up study' 98- 0198-003.
Midparental height reached (difference less than 0.6 SDS)
Prepubertal at start of the study (girls =B 1, boys: testes : breast stage 2, or testes > 4ml).
Poor compliance.

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Data sourced from ClinicalTrials.gov (NCT02879747). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.