Trial · NCT00256126
Predictive Markers in Growth Hormone Deficiency (GHD) and Turner Syndrome (TS) Children Treated With SAIZEN®
NCT00256126, Phase 4, Completed, Merck KGaA, Darmstadt, Germany; results first posted 2018-03-20
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Predictive Markers in Growth Hormone Deficiency (GHD) and Turner Syndrome (TS) Children Treated With SAIZEN®. Trials, record NCT00256126. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00256126
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Predictive Markers in Growth Hormone Deficiency (GHD) and Turner Syndrome (TS) Children Treated With SAIZEN®
- NCT number
- NCT00256126
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 318 participants, actual
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Conditions
- Growth Hormone Deficiency, Turner Syndrome
- Interventions
- Saizen, Saizen
- First posted
- 2005-11-21
- Last updated
- 2018-06-26
- Results first posted
- 2018-03-20
- Limitations and caveats
- Limitations of the trial were short duration of the study treatment, and relatively small sample size
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Insulin Like Growth Factor-1 Standard Deviation Score (IGF-1 SDS) at Month 1 | Baseline, Month 1 | IGF-1 SDS was calculated using the Elmlinger reference method. Change in within subject IGF-1 levels (standard deviation scores) at Month 1 from Baseline was assessed. Descriptive statistics were determined for the Baseline and Month 1 assessments, and also for the level of change between these two assessments. If either the Baseline or Month 1 IGF-1 level was missing, then the within-subject change in IGF-1 was assumed to be missing. |
| Secondary | Change From Baseline in Insulin-like Growth Factor Binding Protein - 3 (IGFBP-3) Level at Month 1 | Baseline, Month 1 | |
| Secondary | Change From Baseline in Fasting Glucose Levels at Month 1 | Baseline, Month 1 | |
| Secondary | Change From Baseline in Fasting Insulin Levels at Month 1 | Baseline, Month 1 | |
| Secondary | Change From Baseline in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) at Month 1 | Baseline, Month 1 | HOMA-IR is used to assess insulin resistance and calculated by an empirical mathematical formula based on fasting plasma glucose and fasting plasma insulin levels. HOMA-IR = fasting plasma insulin (picomole/liter \[pmol/L\]) \* fasting plasma glucose (millimole/liter \[mmol/L\]) divided by 22.5. |
| Secondary | Change From Baseline in Bone Alkaline Phosphatase Levels at Month 1 | Baseline, Month 1 |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Insulin Like Growth Factor-1 Standard Deviation Score (IGF-1 SDS) at Month 1 | Baseline, Month 1 | The Intention to Treat (ITT) population included all subjects who received at least 1 dose of study medication. Here Overall Number of Subjects Analyzed signifies those subjects who were evaluable for this outcome measure. | Standard deviation score (SDS) | MEAN |
| SECONDARY | Change From Baseline in Insulin-like Growth Factor Binding Protein - 3 (IGFBP-3) Level at Month 1 | Baseline, Month 1 | The ITT population included all subjects who received at least 1 dose of study medication. Here Overall Number of Subjects Analyzed signifies those subjects who were evaluable for this outcome measure. | milligram per liter (mg/L) | MEAN |
| SECONDARY | Change From Baseline in Fasting Glucose Levels at Month 1 | Baseline, Month 1 | The ITT population included all subjects who received at least 1 dose of study medication. Here Overall Number of Subjects Analyzed signifies those subjects who were evaluable for this outcome measure. | millimoles per liter (mmol/L) | MEAN |
| SECONDARY | Change From Baseline in Fasting Insulin Levels at Month 1 | Baseline, Month 1 | The ITT population included all subjects who received at least 1 dose of study medication. Here Overall Number of Subjects Analyzed signifies those subjects who were evaluable for this outcome measure. | picomole per liter (pmol/L) | MEAN |
| SECONDARY | Change From Baseline in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) at Month 1 | Baseline, Month 1 | The ITT population included all subjects who received at least 1 dose of study medication. Here Overall Number of Subjects Analyzed signifies those subjects who were evaluable for this outcome measure. | picomole per liter *millimole per liter | MEAN |
| SECONDARY | Change From Baseline in Bone Alkaline Phosphatase Levels at Month 1 | Baseline, Month 1 | The ITT population included all subjects who received at least 1 dose of study medication. Here Overall Number of Subjects Analyzed signifies those subjects who were evaluable for this outcome measure. | Units per liter (U/L) | MEAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Insulin Like Growth Factor-1 Standard Deviation Score (IGF-1 SDS) at Month 1 | Turner Syndrome (TS) | 1.7692 | Standard Deviation 1.1889 | Standard deviation score (SDS) | |
| Change From Baseline in Insulin Like Growth Factor-1 Standard Deviation Score (IGF-1 SDS) at Month 1 | Growth Hormone Deficiency (GHD) | 1.4007 | Standard Deviation 0.9811 | Standard deviation score (SDS) | |
| Change From Baseline in Insulin-like Growth Factor Binding Protein - 3 (IGFBP-3) Level at Month 1 | Turner Syndrome (TS) | 0.86 | Standard Deviation 0.96 | milligram per liter (mg/L) | |
| Change From Baseline in Insulin-like Growth Factor Binding Protein - 3 (IGFBP-3) Level at Month 1 | Growth Hormone Deficiency (GHD) | 0.69 | Standard Deviation 0.81 | milligram per liter (mg/L) | |
| Change From Baseline in Fasting Glucose Levels at Month 1 | Turner Syndrome (TS) | 0.22 | Standard Deviation 0.8 | millimoles per liter (mmol/L) | |
| Change From Baseline in Fasting Glucose Levels at Month 1 | Growth Hormone Deficiency (GHD) | 0.13 | Standard Deviation 0.65 | millimoles per liter (mmol/L) | |
| Change From Baseline in Fasting Insulin Levels at Month 1 | Turner Syndrome (TS) | 47.7 | Standard Deviation 177.2 | picomole per liter (pmol/L) | |
| Change From Baseline in Fasting Insulin Levels at Month 1 | Growth Hormone Deficiency (GHD) | 26.9 | Standard Deviation 79.8 | picomole per liter (pmol/L) | |
| Change From Baseline in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) at Month 1 | Turner Syndrome (TS) | 2.132 | Standard Deviation 10.296 | picomole per liter *millimole per liter | |
| Change From Baseline in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) at Month 1 | Growth Hormone Deficiency (GHD) | 1.061 | Standard Deviation 3.885 | picomole per liter *millimole per liter |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Turner Syndrome (TS) | 149 | |
| Overall Study | STARTED | Growth Hormone Deficiency (GHD) | 169 | |
| Overall Study | COMPLETED | Turner Syndrome (TS) | 147 | |
| Overall Study | COMPLETED | Growth Hormone Deficiency (GHD) | 167 | |
| Overall Study | NOT COMPLETED | Turner Syndrome (TS) | 2 | |
| Overall Study | NOT COMPLETED | Growth Hormone Deficiency (GHD) | 2 |
Source ClinicalTrials.gov
Adverse events104
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Seasonal allergy | Immune system disorders | Turner Syndrome (TS) | 0 | 149 | 0 |
| other | Seasonal allergy | Immune system disorders | Growth Hormone Deficiency (GHD) | 1 | 169 | 1 |
| other | Pyrexia | General disorders | Turner Syndrome (TS) | 6 | 149 | 7 |
| other | Pyrexia | General disorders | Growth Hormone Deficiency (GHD) | 9 | 169 | 9 |
| other | Injection site haemorrhage | General disorders | Turner Syndrome (TS) | 1 | 149 | 1 |
| other | Injection site haemorrhage | General disorders | Growth Hormone Deficiency (GHD) | 1 | 169 | 1 |
| other | Injection site irritation | General disorders | Turner Syndrome (TS) | 0 | 149 | 0 |
| other | Injection site irritation | General disorders | Growth Hormone Deficiency (GHD) | 1 | 169 | 2 |
| other | Fatigue | General disorders | Turner Syndrome (TS) | 0 | 149 | 0 |
| other | Fatigue | General disorders | Growth Hormone Deficiency (GHD) | 1 | 169 | 1 |
1 to 10 of 104Source ClinicalTrials.gov
See all 104 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Turner Syndrome (TS) | ||
| Total, all-cause mortality | Growth Hormone Deficiency (GHD) | ||
| Total, other adverse events | Turner Syndrome (TS) | 36 | 149 |
| Total, other adverse events | Growth Hormone Deficiency (GHD) | 51 | 169 |
| Total, serious adverse events | Turner Syndrome (TS) | 0 | 149 |
| Total, serious adverse events | Growth Hormone Deficiency (GHD) | 1 | 169 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Turner Syndrome (TS) vs Growth Hormone Deficiency (GHD): serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00256126
GET https://conductscience.org/api/trials/v1/NCT00256126/events?page=2