Primary outcomeMean· Year 4
Height SDS at Year 4
| Group | Value (standard deviation score) | Spread |
|---|---|---|
| r-hGH | -1.35 | 0.86 |
| Historical Control | -2.44 | 0.73 |
Trial · Interventional
CompletedPhase 4Results postedRegistry dataGrowth Hormone Treatment for the Prevention of Short Stature in Young Girls With Turner Syndrome Before the Age of 4 Years
NCTNCT01066052 (opens ClinicalTrials.gov in a new tab)Other idGF 5834
Overview
- Status
- Completed
- Phase
- Phase 4
- Enrollment
- 115 participants (actual)
- Sponsor
- Merck KGaA, Darmstadt, Germany · Industry
- Design
- Not randomized · Open label (no masking)
- Countries
1 country
France
- Start
- 29 Feb 1992
- Primary completion
- 31 Mar 1999
- Completion
- 31 Aug 2010
- First posted
- 10 Feb 2010 (estimated)
- Last update posted
- 14 Dec 2018
- Conditions
- Turner's Syndrome
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
1995200020052010
- Ph 4
Growth Hormone Treatment for the Prevention of Short Stature in Young Girls With Turner Syndrome Before the Age of 4 Years
NCT0106605229 Feb 1992 to 31 Aug 2010
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- r-hGHDrug
Arms2
Experimental
r-hGH
Participants (girls) will receive r-hGH as a subcutaneous injection administered by a parent in the evening. During Years 1-2, the dose of r-hGH received will depend on participants' baseline height standard deviation score (SDS) relative to the general population standard: participants with a height SDS of -2 standard deviation (SD) or lower will receive 0.05 milligrams per kilogram (mg/kg) per day r-hGH and those with a height SDS between -1 and -2 SD will receive 0.035 mg/kg per day r-hGH. After 2 years of treatment, all participants will receive a fixed dose of 0.05 mg/kg per day for a further 2 years.
No intervention
Historical Control
This arm will include matching (age and height) historical control participants (girls) with turner syndrome, who were born between 1961 and 1990 and were untreated.
Primary outcomes1
Outcomes the sponsor listed as primary.
Height SDS at Year 4
Time frame · Year 4
Registry description
Height SDS was calculated as height minus reference mean height divided by standard deviation of the reference population. Height SDS reflects the height relative to a reference population of the same age and gender.
Secondary outcomes(5)
Number of Participants With Abnormal Glycated Hemoglobin (HbA1c) Levels
Time frame · Baseline up to Year 2
Registry description
HbA1c develops when hemoglobin, a protein within red blood cells that carries oxygen throughout the body, joins with glucose in the blood, becoming glycated. The higher the level of glucose in the blood, the higher the level of HbA1c is detectable on red blood cells. The normal range for HbA1c is 4 percent (%) to 5.9%. Number of participants, who had abnormal HbA1c levels any time during the assessment, were reported.
Difference Between Bone Age (BA) and Chronological Age (CA) (BA-CA)
Time frame · Baseline, Year 1, Year 2
Registry description
BA was determined using left wrist and hand X-ray. CA was determined using the date of birth. Difference of BA and CA (BA-CA) was reported.
Number of Participants With Anti r-hGH Antibodies
Time frame · Baseline up to Year 2
Number of Participants With Abnormal Insulin-Like Growth Factor 1 (IGF1) Levels
Time frame · Baseline up to Year 2
Registry description
The normal range for IGF1 levels is 45 to 117 nanogram per milliliter (ng/mL) for girls aged less than (\<) 3 years and 80 to 236 ng/mL for girls aged 3 to 6 years. Values outside the normal range were considered abnormal. Number of participants, who had abnormal IGF1 levels any time during the assessment, were reported.
Number of Participants Who Reached Normal Height at Year 4
Time frame · Year 4
Registry description
Participants with normal height were those who attained a height which was within +/- 2 height SDS of reference population standard. Height SDS was calculated as height minus reference mean height divided by standard deviation of the reference population. Height SDS reflects the height relative to a reference population of the same age and gender.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(5)
Secondary outcomeNumber· Baseline up to Year 2
Number of Participants With Abnormal Glycated Hemoglobin (HbA1c) Levels
| Group | Value (participants) |
|---|---|
| r-hGH | 1 |
Secondary outcomeMean· Baseline, Year 1, Year 2
Difference Between Bone Age (BA) and Chronological Age (CA) (BA-CA)
| Group | Value (months) | Spread |
|---|---|---|
| r-hGH | -8.9 | 7.5 |
Secondary outcome· Baseline up to Year 2
Number of Participants With Anti r-hGH Antibodies
| Group | Value |
|---|---|
| r-hGH | not posted |
| Historical Control | not posted |
Secondary outcomeNumber· Baseline up to Year 2
Number of Participants With Abnormal Insulin-Like Growth Factor 1 (IGF1) Levels
| Group | Value (participants) |
|---|---|
| r-hGH | 46 |
Secondary outcomeNumber· Year 4
Number of Participants Who Reached Normal Height at Year 4
| Group | Value (participants) |
|---|---|
| r-hGH | 49 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| r-hGHParticipants (girls) received r-hGH as a subcutaneous injection administered by a parent in the evening. During Years 1-2, the dose of r-hGH received depended on participants' baseline height SDS relative to the general population standard: participants with a height SDS of -2 SD or lower received 0.05 mg/kg per day r-hGH and those with a height SDS between -1 and -2 SD received 0.035 mg/kg per day r-hGH. After 2 years of treatment, all participants received a fixed dose of 0.05 mg/kg per day for a further 2 years. | – | 8 / 61 | 47 / 61 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies1
Studies that cite this trial.
More studies
1 study on this page
Indexing hint: Clinical trial · 2011
Growth hormone treatment before the age of 4 years prevents short stature in young girls with Turner syndrome.
Linglart et al. 2011European journal of endocrinologycited by 36
PMID 21398400DOI 10.1530/eje-10-1048PUB-21398400
Full text at the publisher
Eligibility
Who could join, as posted.
- Sex
- Female
- Age
- up to 4 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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
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