Phase 4
Completed N=115
Growth Hormone Treatment for the Prevention of Short Stature in Young Girls With Turner Syndrome Before the Age of 4 Years
Turner's Syndrome
Source: ClinicalTrials.gov NCT01066052 ↗
Enrolled (actual)
115
Serious AEs
13.1%
Results posted
Dec 2018
Primary outcomePrimary: Height SDS at Year 4 — -1.35; -2.44 standard deviation score
◆ Published Evidence
Established
62citations · ~4 / year
Growth hormone treatment before the age of 4 years prevents short stature in young girls with Turner syndrome.
Summary
The objective of this study is to evaluate the efficacy and safety of recombinant human growth hormone (r-hGH) treatment in girls with Turner Syndrome under the age of 4 years. After 4 years of treatment, height in these girls will be compared with an historical control group of untreated girls with Turner Syndrome, matched for age and height at baseline.
Linked Publications
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Growth hormone treatment before the age of 4 years prevents short stature in young girls with Turner syndrome.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Height SDS at Year 4 |
-1.35; -2.44 | — |
| SECONDARY Number of Participants With Abnormal Glycated Hemoglobin (HbA1c) Levels |
1 | — |
| SECONDARY Difference Between Bone Age (BA) and Chronological Age (CA) (BA-CA) |
-8.9; -8.7; -8.1 | — |
| SECONDARY Number of Participants With Anti r-hGH Antibodies |
— | — |
| SECONDARY Number of Participants With Abnormal Insulin-Like Growth Factor 1 (IGF1) Levels |
46 | — |
| SECONDARY Number of Participants Who Reached Normal Height at Year 4 |
49 | — |
Eligibility Criteria
Inclusion Criteria
- Young girls with turner syndrome proved by karyotype
- Growth hormone secretion confirmed with ornithin stimulation test
- Normal glucidic metabolism confirmed by assessment of HbA1c
- None associated severe pathology which could have impact on growth (i.e. renal insufficiency, decompensated heart failure)
- No previous or associated treatment with anabolic or sexual steroids
- Known parental height
Exclusion Criteria
- Severe associated pathology with impact on growth
- Concomitant treatment with impact on growth
- Previous or associated treatment with anabolic steroids
- Associated growth hormone deficiency
Data sourced from ClinicalTrials.gov (NCT01066052) 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.