Phase 3
N=154
Somatropin Treatment to Final Height in Turner Syndrome
Turner Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT00191113 ↗Enrolled (actual)
154
Serious AEs
25.0%
Results posted
Jan 2010
Primary outcome: Primary: Height Standard Deviation Score (SDS) (National Center for Health Statistics [NCHS]), Change From Baseline to Last Measurement, As Randomized Population — 0.09; 0.97 Standard Deviation Score (SDS) [NCHS] — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Somatropin (Drug); Ethinyl estradiol (Drug); Medroxyprogesterone acetate (Drug)
- Age
- Pediatric · 7+ yrs
- Sex
- Female
- Sponsor
- Eli Lilly and Company
- Primary completion
- Dec 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Height Standard Deviation Score (SDS) (National Center for Health Statistics [NCHS]), Change From Baseline to Last Measurement, As Randomized Population |
0.09; 0.97 | <0.001 sig |
| PRIMARY Height Standard Deviation Score (SDS) (National Center for Health Statistics [NCHS]), Last Measurement After Attainment of Final Height |
-3.30; -2.25 | <0.001 sig |
| SECONDARY Height Standard Deviation Score (SDS) (National Center for Health Statistics [NCHS]), Change From Baseline, As-Treated Population |
-0.09; 0.99 | <0.001 sig |
| SECONDARY Height (Centimeters [cm]) |
141.63; 148.52 | <0.001 sig |
| SECONDARY Number of Participants With an Abnormal Pure Tone Audiometry, Audiologist Assessment |
10; 29 | >0.999 |
| SECONDARY Number of Participants With Abnormal Speech Audiometry, Audiologist Assessment |
3; 12 | 0.744 |
| SECONDARY Number of Participants With Abnormal Impedance Tympanometry, Audiologist Assessment |
2; 18 | 0.073 |
| SECONDARY Number of Participants With Hearing Loss, Audiologist Assessment |
1; 7; 8; 15; 2; 9 | >0.999 |
| SECONDARY Fasting Glucose, Change From Baseline |
5.495; 3.003 | 0.419 |
| SECONDARY Maximum Fasting Glucose Value |
85.2; 85.2 | — |
| SECONDARY Number of Participants With Any Abnormal Fasting Glucose Value |
0; 3 | 0.545 |
| SECONDARY Maximum Fasting Insulin Values |
9.5; 9.7 | — |
| SECONDARY Number of Participants With Any Abnormal Fasting Insulin Value |
1; 2 | >0.999 |
| SECONDARY Minimum Fasting Glucose/Insulin Ratio Values |
12.5; 12.2 | — |
| SECONDARY Number of Participants With Any Abnormal Fasting Glucose/Insulin Ratio Value |
1; 3 | >0.999 |
| SECONDARY Glycosylated Hemoglobin, Change From Baseline |
0.215; 0.208 | 0.945 |
| SECONDARY Maximum Glycosylated Hemoglobin |
5.0; 5.0 | — |
| SECONDARY Number of Participants With Any Abnormal Glycosylated Hemoglobin (HbA1c) Value |
0; 0 | — |
Summary
A randomized, controlled trial in girls with Turner syndrome at least 7 years old and younger than 13 at study entry, to determine the efficacy and safety of Humatrope (somatropin) treatment in promoting linear growth to final height.
Eligibility Criteria
Inclusion Criteria
- girl with Turner syndrome
- prepubertal, Tanner stage I breast
- height velocity less than 6 cm/year and height less than or equal to the tenth percentile for sex and age in general population
- at least 6 months (preferably 12 months) of accurate height measurements available for calculation of pre-study height velocity
- if thyroxine deficient, to have received replacement therapy, and for six months prior to enrollment have had normal thyroid function tests
Exclusion Criteria
- prior treatment with growth hormone
- presence of a Y component in karyotype with gonads in situ
- diabetes mellitus
Data sourced from ClinicalTrials.gov (NCT00191113). 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.