Phase 3
Completed N=98
Individualizing Dose of Growth Hormone to Maintain Normal Growth Velocity After Fulfilled Catch up Growth in Children
Source: ClinicalTrials.gov NCT02879747 ↗Enrolled (actual)
98
Serious AEs
10.2%
Results posted
Apr 2019
Primary outcomePrimary: The Proportion of Children Maintaining Normal Growth Velocity — 23; 32; 31 Participants
◆ Published Evidence
Established
84citations · ~5 / year
Growth hormone (GH) dosing during catch-up growth guided by individual responsiveness decreases growth response variability in prepubertal children with GH deficiency or idiopathic short stature.
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).
Linked Publications (3)
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Growth hormone (GH) dosing during catch-up growth guided by individual responsiveness decreases growth response variability in prepubertal children with GH deficiency or idiopathic short stature.
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GH Dose Reduction Maintains Normal Prepubertal Height Velocity After Initial Catch-Up Growth in Short Children.
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Interpreting IGF-1 in children treated with recombinant growth hormone: challenges during early puberty.
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 | — |
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.
Data sourced from ClinicalTrials.gov (NCT02879747) and the linked publication. 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. Informational only — not medical advice.