Trial · NCT00163189
Evolution Of Growth Rate In Children With Growth Retardation Due to Glucocorticosteroid Therapy And Treated By Genotonorm
NCT00163189, Phase 3, Completed, Pfizer; results first posted 2015-06-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Evolution Of Growth Rate In Children With Growth Retardation Due to Glucocorticosteroid Therapy And Treated By Genotonorm. Trials, record NCT00163189. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00163189
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evolution Of Growth Rate In Children With Growth Retardation Due to Glucocorticosteroid Therapy And Treated By Genotonorm
- NCT number
- NCT00163189
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 98 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Growth Hormone Deficiency
- Interventions
- Somatropin
- First posted
- 2005-09-13
- Last updated
- 2024-02-21
- Other registries' IDs
- eudract:2004-002992-17
- Results first posted
- 2015-06-25
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Month 36: Full Analysis Population | Baseline, Month 36 | Height was measured using a wall mounted device (example, Harpenden stadiometer). The standing height of the participant was measured two times and the mean of these measurements was recorded. Height SDS CA Yx = (height Yx - reference mean for CA Yx) / reference SD for CA Yx; Yx refers to the value at particular timepoint x. Height in SDS was calculated using Sempe reference means and SD for height. CA calculated as integer (Date of height measurement-Date of birth)/365.25\*12. |
| Primary | Change From Baseline in Height Standard Deviation Score (SD) for Chronological Age (CA) at Month 36: Per Protocol (PP) Population | Baseline, Month 36 | Height was measured using a wall mounted device (example, Harpenden stadiometer). The standing height of the participant was measured two times and the mean of these measurements was recorded. Height SDS CA Yx = (height Yx - reference mean for CA Yx) / reference SD for CA Yx; Yx refers to the value at particular timepoint x. Height in SDS was calculated using Sempe reference means and SD for height. CA calculated as integer (Date of height measurement-Date of birth)/365.25\*12. |
| Secondary | Mean Height | Baseline, Month 12, 24, 36, 48, 60 | The standing height measurements were performed using a wall mounted device (example Harpenden Stadiometer). The standing height of the participant was measured two times and the mean of these measurements was recorded. |
| Secondary | Mean Height Standard Deviation Score (SDS) for Bone Age (BA) | Baseline, Month 12, 24, 36, 48, 60 | The standing height measurements were performed using a wall mounted device (example Harpenden Stadiometer). The standing height of the participant was measured two times and the mean of these measurements was recorded. Height SDS BA Yx = (height Yx - reference mean for BA Yx) / reference SD for BA Yx; Yx refers to the value at particular timepoint x. Height in SDS was calculated using Sempe reference means and SD for height. BA was estimated locally using an X-ray from the left wrist and hand. |
| Secondary | Annual Growth Rate (AGR) | Baseline, Month 12, 24, 36, 48, 60 | AGR at Yx was derived by subtracting AGR at baseline from Yx value. AGR was calculated each year and re scaled to 1 year if the interval between Yx and Y\[x-1\] was not 365 days, as long as a participant remained in the study. AGR at Yx was calculated using the previous height measurements (Y\[x-1\]) and height recorded at Yx (AGR Yx = \[height Yx-height Y{x-1}\] / (\[date of Yx - date of Y{x-1}\] /365.25). Yx refers to the value at particular timepoint x. |
| Secondary | Growth Rate (GR) Standard Deviation Score (SDS) for Bone Age (BA) | Month 12, 24, 36, 48, 60 | GR SDS BA Yx = (GR Yx - reference mean for BA Yx) / reference SD for BA Yx; Yx refers to the value at particular timepoint x. GR in SDS was calculated using Sempe reference means and SD for GR. BA was estimated locally using an X-ray from the left wrist and hand. |
| Secondary | Growth Rate (GR) Standard Deviation Score (SDS) for Chronological Age (CA) | Baseline, Month 12, 24, 36, 48, 60 | GR SDS CA Yx = (GR Yx - reference mean for CA Yx) / reference SD for CA Yx; Yx refers to the value at particular timepoint x. GR in SDS was calculated using Sempe reference means and SD for GR. CA calculated as integer (Date of height measurement-Date of birth)/365.25\*12. |
| Secondary | Body Mass Index (BMI) | Baseline, Month 12, 24, 36, 48, 60 | BMI was calculated by weight divided by height squared and measured as kilogram per square meter (kg/m\^2). |
| Secondary | Change From Baseline in Height at Month 12, 24, 36, 48 and 60 | Baseline, Month 12, 24, 36, 48, 60 | The standing height measurements were performed using a wall mounted device (example Harpenden Stadiometer). The standing height of the participant was measured two times and the mean of these measurements was recorded. |
| Secondary | Change From Baseline in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Month 12, 24, 48 and 60 | Baseline, Month 12, 24, 48, 60 | The standing height measurements were performed using a wall mounted device (example Harpenden Stadiometer). The standing height of the participant was measured two times and the mean of these measurements was recorded. Height SDS CA Yx = (height Yx - reference mean for CA Yx) / reference SD for CA Yx; Yx refers to the value at particular timepoint x. Height in SDS was calculated using Sempe reference means and SD for height. CA calculated as integer (Date of height measurement-Date of birth)/365.25\*12. |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes19
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 Height Standard Deviation Score (SDS) for Chronological Age (CA) at Month 36: Full Analysis Population | Baseline, Month 36 | Full analysis set (FAS) included all participants (excluding a site with GCP issues) who had received at least 1 injection of GH and had at least 1 post-Baseline measurement of height. Here n signifies those participants who were evaluable for the specified time point. | Standard Deviation Score (SDS) | MEAN |
| PRIMARY | Change From Baseline in Height Standard Deviation Score (SD) for Chronological Age (CA) at Month 36: Per Protocol (PP) Population | Baseline, Month 36 | PP analysis set included all participants (excluding a site with GCP issues) who received at least 1 dose of GH, had at least 1 subsequent rating of height, no major protocol violation till first 3 years post initiation of treatment and total GH treatment duration of 36 months or more. n=participants evaluable at the specified time point. | SDS | MEAN |
| SECONDARY | Mean Height | Baseline, Month 12, 24, 36, 48, 60 | FAS included all participants (excluding a site with GCP issues) who had received at least 1 injection of GH and had at least 1 post-Baseline measurement of height. Here n signifies those participants who were evaluable for the specified time point. | centimeters (cm) | MEAN |
| SECONDARY | Mean Height Standard Deviation Score (SDS) for Bone Age (BA) | Baseline, Month 12, 24, 36, 48, 60 | FAS included all participants (excluding a site with GCP issues) who had received at least 1 injection of GH and had at least 1 post-Baseline measurement of height. Here n signifies those participants who were evaluable for the specified time point. | SDS | MEAN |
| SECONDARY | Annual Growth Rate (AGR) | Baseline, Month 12, 24, 36, 48, 60 | FAS included all participants (excluding a site with GCP issues) who had received at least 1 injection of GH and had at least 1 post-Baseline measurement of height. Here n signifies those participants who were evaluable for the specified time point. | cm/year | MEAN |
| SECONDARY | Growth Rate (GR) Standard Deviation Score (SDS) for Bone Age (BA) | Month 12, 24, 36, 48, 60 | FAS included all participants (excluding a site with GCP issues) who had received at least 1 injection of GH and had at least 1 post-Baseline measurement of height. Here n signifies those participants who were evaluable for the specified time point. | SDS | MEAN |
| SECONDARY | Growth Rate (GR) Standard Deviation Score (SDS) for Chronological Age (CA) | Baseline, Month 12, 24, 36, 48, 60 | FAS included all participants (excluding a site with GCP issues) who had received at least 1 injection of GH and had at least 1 post-Baseline measurement of height. Here n signifies those participants who were evaluable for the specified time point. | SDS | MEAN |
| SECONDARY | Body Mass Index (BMI) | Baseline, Month 12, 24, 36, 48, 60 | FAS included all participants (excluding a site with GCP issues) who had received at least 1 injection of GH and had at least 1 post-Baseline measurement of height. Here n signifies those participants who were evaluable for the specified time point. | kg/m^2 | MEAN |
| SECONDARY | Change From Baseline in Height at Month 12, 24, 36, 48 and 60 | Baseline, Month 12, 24, 36, 48, 60 | FAS included all participants (excluding a site with GCP issues) who had received at least 1 injection of GH and had at least 1 post-Baseline measurement of height. Here n signifies those participants who were evaluable for the specified time point. | cm | MEAN |
| SECONDARY | Change From Baseline in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Month 12, 24, 48 and 60 | Baseline, Month 12, 24, 48, 60 | FAS included all participants (excluding a site with GCP issues) who had received at least 1 injection of GH and had at least 1 post-Baseline measurement of height. Here n signifies those participants who were evaluable for the specified time point. | SDS | MEAN |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 outcomesResults by group102
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 Height Standard Deviation Score (SDS) for Chronological Age (CA) at Month 36: Full Analysis Population | Genotonorm | Baseline (n=58) | -2.91 | Standard Deviation 1.19 | Standard Deviation Score (SDS) |
| Change From Baseline in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Month 36: Full Analysis Population | Genotonorm | Change at Month 36 (n=30) | 0.80 | Standard Deviation 1.03 | Standard Deviation Score (SDS) |
| Change From Baseline in Height Standard Deviation Score (SD) for Chronological Age (CA) at Month 36: Per Protocol (PP) Population | Genotonorm | Baseline (n=21) | -2.86 | Standard Deviation 0.89 | SDS |
| Change From Baseline in Height Standard Deviation Score (SD) for Chronological Age (CA) at Month 36: Per Protocol (PP) Population | Genotonorm | Change at Month 36 (n=19) | 0.81 | Standard Deviation 1.18 | SDS |
| Mean Height | Genotonorm | Baseline (n=58) | 133.9 | Standard Deviation 15.7 | centimeters (cm) |
| Mean Height | Genotonorm | Month 12 (n=50) | 139.5 | Standard Deviation 16.8 | centimeters (cm) |
| Mean Height | Genotonorm | Month 24 (n=41) | 146.0 | Standard Deviation 16.4 | centimeters (cm) |
| Mean Height | Genotonorm | Month 36 (n=30) | 150.4 | Standard Deviation 16.0 | centimeters (cm) |
| Mean Height | Genotonorm | Month 48 (n=14) | 152.4 | Standard Deviation 16.0 | centimeters (cm) |
| Mean Height | Genotonorm | Month 60 (n=9) | 156.0 | Standard Deviation 11.3 | centimeters (cm) |
1 to 10 of 102Source ClinicalTrials.gov
See all 102 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Genotonorm | 98 | |
| Overall Study | COMPLETED | Genotonorm | 35 | |
| Overall Study | NOT COMPLETED | Genotonorm | 63 |
Source ClinicalTrials.gov
Adverse events264
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 | Bronchitis | Infections and infestations | Genotonorm | 8 | 98 | |
| other | Nasopharyngitis | Infections and infestations | Genotonorm | 6 | 98 | |
| other | Tonsillitis | Infections and infestations | Genotonorm | 6 | 98 | |
| other | Gastroenteritis | Infections and infestations | Genotonorm | 5 | 98 | |
| other | Pharyngitis | Infections and infestations | Genotonorm | 5 | 98 | |
| other | Influenza | Infections and infestations | Genotonorm | 4 | 98 | |
| other | Rhinitis | Infections and infestations | Genotonorm | 4 | 98 | |
| other | Varicella | Infections and infestations | Genotonorm | 4 | 98 | |
| other | Ear infection | Infections and infestations | Genotonorm | 3 | 98 | |
| other | Urinary tract infection | Infections and infestations | Genotonorm | 3 | 98 |
1 to 10 of 264Source ClinicalTrials.gov
See all 264 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Genotonorm | ||
| Total, other adverse events | Genotonorm | 81 | 98 |
| Total, serious adverse events | Genotonorm | 45 | 98 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30910221 | DERIVED |
Source PubMed
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
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