Trial · NCT00174291
Prevention of Growth Retardation by Early Treatment With Growth Hormone (GH) in Children With CJA Treated by Corticosteroid Therapy
NCT00174291, Phase 3, Terminated, Pfizer; results first posted 2012-12-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Prevention of Growth Retardation by Early Treatment With Growth Hormone (GH) in Children With CJA Treated by Corticosteroid Therapy. Trials, record NCT00174291. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00174291
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Prevention of Growth Retardation by Early Treatment With Growth Hormone (GH) in Children With CJA Treated by Corticosteroid Therapy
- NCT number
- NCT00174291
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 21 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Endocrine System Diseases
- Interventions
- Somatropin
- First posted
- 2005-09-15
- Last updated
- 2012-12-04
- Results first posted
- 2012-12-04
- Limitations and caveats
Data for bone mineral density (BMD), bone mineral content (BMC) and IGFBP3 were not analyzed because of change in planned analysis after the study was prematurely terminated due to Good Clinical Practice (GCP) non-compliance issues.
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Annual Rate of Growth Standard Deviation Score (SDS) at Year 3 | Baseline, Year 3 | Annual rate of growth SDS was obtained by measuring the annual growth rate, subtracting chronological age- and gender-appropriate mean annual growth rate and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population. |
| Primary | Change From Baseline in Annual Rate of Growth Standard Deviation Score (SDS) at Final Height | Baseline, final height (assessed up to Year 9.5) | Annual rate of growth SDS was obtained by measuring the annual growth rate, subtracting chronological age- and gender-appropriate mean annual growth rate and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population. |
| Primary | Change From Baseline in Height Standard Deviation Score (SDS) at Year 3 | Baseline, Year 3 | Height was measured using a wall mounted device (example, Harpenden stadiometer). Height SDS was obtained by measuring the height, subtracting chronological age- and gender-appropriate mean height and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population. |
| Primary | Change From Baseline in Height Standard Deviation Score (SDS) at Final Height | Baseline, final height (assessed up to Year 9.5) | Height was measured using a wall mounted device (example, Harpenden stadiometer). Height SDS was obtained by measuring the height, subtracting chronological age- and gender-appropriate mean height and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population. |
| Primary | Change From Baseline in Predicted Height Standard Deviation Score (SDS) at Year 3 | Baseline, Year 3 | Predicted height was calculated according to Greulich and Pyle using Bayley Pinneau method. Predicted height SDS was obtained by calculating the predicted height, subtracting chronological age- and gender-appropriate mean predicted height and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population. |
| Primary | Change From Baseline in Predicted Height Standard Deviation Score (SDS) at Final Height | Baseline, final height (assessed up to Year 9.5) | Predicted height was calculated according to Greulich and Pyle using Bayley Pinneau method. Predicted height SDS was obtained by calculating the predicted height, subtracting chronological age- and gender-appropriate mean predicted height and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population. |
| Secondary | Change From Baseline in Insulin-like Growth Factor-1 (IGF-1) Concentration at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Baseline, Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9 | |
| Secondary | Change From Baseline in Insulin-like Growth Factor Binding Protein 3 (IGFBP3) Concentration at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Baseline, Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9 | |
| Secondary | Change From Baseline in Lean Mass and Fat Mass at Year 1, 2, 3, 4, 5, 6, 7, 8 and 9 | Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9 | Lean mass and fat mass: measurements of body composition assessed using Dual Energy X-ray Absorptiometry (DEXA) scan. |
| Secondary | Change From Baseline in Bone Mineralization at Year 1, 2, 3, 4, 5, 6, 7, 8 and 9 | Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9 | Bone mineralization, an estimate of the amount of mineral (such as calcium) in the bone, was assessed using DEXA scan. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
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 Annual Rate of Growth Standard Deviation Score (SDS) at Year 3 | Baseline, Year 3 | Full Analysis Set (FAS) included all participants who received at least 1 dose of study treatment and had at least 1 post-baseline height measurement. Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure. | SDS | MEDIAN |
| PRIMARY | Change From Baseline in Annual Rate of Growth Standard Deviation Score (SDS) at Final Height | Baseline, final height (assessed up to Year 9.5) | Data was not analyzed because of change in planned analysis after early termination of the study. | ||
| PRIMARY | Change From Baseline in Height Standard Deviation Score (SDS) at Year 3 | Baseline, Year 3 | FAS included all participants who received at least 1 dose of study treatment and had at least 1 post-baseline height measurement. Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure. | SDS | MEDIAN |
| PRIMARY | Change From Baseline in Height Standard Deviation Score (SDS) at Final Height | Baseline, final height (assessed up to Year 9.5) | FAS included all participants who received at least 1 dose of study treatment and had at least 1 post-baseline height measurement. Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure. | SDS | MEDIAN |
| PRIMARY | Change From Baseline in Predicted Height Standard Deviation Score (SDS) at Year 3 | Baseline, Year 3 | FAS included all participants who received at least 1 dose of study treatment and had at least 1 post-baseline height measurement. Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure. | SDS | MEDIAN |
| PRIMARY | Change From Baseline in Predicted Height Standard Deviation Score (SDS) at Final Height | Baseline, final height (assessed up to Year 9.5) | FAS included all participants who received at least 1 dose of study treatment and had at least 1 post-baseline height measurement. Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure. | SDS | MEDIAN |
| SECONDARY | Change From Baseline in Insulin-like Growth Factor-1 (IGF-1) Concentration at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Baseline, Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9 | FAS included all participants who received at least 1 dose of study treatment and had at least 1 post-baseline height measurement. Here, 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively. | milligram per deciliter (mg/dL) | MEDIAN |
| SECONDARY | Change From Baseline in Insulin-like Growth Factor Binding Protein 3 (IGFBP3) Concentration at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9 | Baseline, Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9 | Data were collected and reported in individual participant listing but not statistically summarized due to early termination of the study. | ||
| SECONDARY | Change From Baseline in Lean Mass and Fat Mass at Year 1, 2, 3, 4, 5, 6, 7, 8 and 9 | Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9 | Data were collected and reported in individual participant listing but not statistically summarized due to early termination of the study. | ||
| SECONDARY | Change From Baseline in Bone Mineralization at Year 1, 2, 3, 4, 5, 6, 7, 8 and 9 | Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9 | FAS included all participants who received at least 1 dose of study treatment and had at least 1 post-baseline height measurement. Here, 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively. | grams | MEDIAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group154
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 Annual Rate of Growth Standard Deviation Score (SDS) at Year 3 | Somatropin (With Previous Somatropin Exposure) | Baseline | -0.21 | Full Range -3.0 to 4.5 | SDS |
| Change From Baseline in Annual Rate of Growth Standard Deviation Score (SDS) at Year 3 | Somatropin (Without Previous Somatropin Exposure) | Baseline | -2.96 | Full Range -6.4 to 1.5 | SDS |
| Change From Baseline in Annual Rate of Growth Standard Deviation Score (SDS) at Year 3 | Somatropin (With Previous Somatropin Exposure) | Change at Year 3 | 1.34 | Full Range -3.6 to 6.2 | SDS |
| Change From Baseline in Annual Rate of Growth Standard Deviation Score (SDS) at Year 3 | Somatropin (Without Previous Somatropin Exposure) | Change at Year 3 | 3.52 | Full Range -5.1 to 11.2 | SDS |
| Change From Baseline in Height Standard Deviation Score (SDS) at Year 3 | Somatropin (With Previous Somatropin Exposure) | Baseline | -0.61 | Full Range -3.7 to 1.4 | SDS |
| Change From Baseline in Height Standard Deviation Score (SDS) at Year 3 | Somatropin (Without Previous Somatropin Exposure) | Baseline | -2.34 | Full Range -4.8 to -1.4 | SDS |
| Change From Baseline in Height Standard Deviation Score (SDS) at Year 3 | Somatropin (With Previous Somatropin Exposure) | Change at Year 3 | 0.73 | Full Range -2.4 to 2.6 | SDS |
| Change From Baseline in Height Standard Deviation Score (SDS) at Year 3 | Somatropin (Without Previous Somatropin Exposure) | Change at Year 3 | 1.21 | Full Range -0.7 to 2.4 | SDS |
| Change From Baseline in Height Standard Deviation Score (SDS) at Final Height | Somatropin (With Previous Somatropin Exposure) | Baseline | 0.96 | Full Range -3.7 to 2.3 | SDS |
| Change From Baseline in Height Standard Deviation Score (SDS) at Final Height | Somatropin (Without Previous Somatropin Exposure) | Baseline | -0.94 | Full Range -1.4 to -0.5 | SDS |
1 to 10 of 154Source ClinicalTrials.gov
See all 154 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Somatropin (With Previous Somatropin Exposure) | 11 | |
| Overall Study | STARTED | Somatropin (Without Previous Somatropin Exposure) | 10 | |
| Overall Study | COMPLETED | Somatropin (With Previous Somatropin Exposure) | 6 | |
| Overall Study | COMPLETED | Somatropin (Without Previous Somatropin Exposure) | 4 | |
| Overall Study | NOT COMPLETED | Somatropin (With Previous Somatropin Exposure) | 5 | |
| Overall Study | NOT COMPLETED | Somatropin (Without Previous Somatropin Exposure) | 6 |
Source ClinicalTrials.gov
Adverse events250
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 | Anaemia | Blood and lymphatic system disorders | Somatropin (With Previous Somatropin Exposure) | 0 | 11 | |
| other | Anaemia | Blood and lymphatic system disorders | Somatropin (Without Previous Somatropin Exposure) | 1 | 10 | |
| other | Blood disorder | Blood and lymphatic system disorders | Somatropin (With Previous Somatropin Exposure) | 1 | 11 | |
| other | Blood disorder | Blood and lymphatic system disorders | Somatropin (Without Previous Somatropin Exposure) | 0 | 10 | |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Somatropin (With Previous Somatropin Exposure) | 0 | 11 | |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Somatropin (Without Previous Somatropin Exposure) | 1 | 10 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Somatropin (With Previous Somatropin Exposure) | 1 | 11 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Somatropin (Without Previous Somatropin Exposure) | 1 | 10 | |
| other | Congenital scoliosis | Congenital, familial and genetic disorders | Somatropin (With Previous Somatropin Exposure) | 1 | 11 | |
| other | Congenital scoliosis | Congenital, familial and genetic disorders | Somatropin (Without Previous Somatropin Exposure) | 0 | 10 |
1 to 10 of 250Source ClinicalTrials.gov
See all 250 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Somatropin (With Previous Somatropin Exposure) | ||
| Total, all-cause mortality | Somatropin (Without Previous Somatropin Exposure) | ||
| Total, other adverse events | Somatropin (With Previous Somatropin Exposure) | 11 | 11 |
| Total, other adverse events | Somatropin (Without Previous Somatropin Exposure) | 9 | 10 |
| Total, serious adverse events | Somatropin (With Previous Somatropin Exposure) | 6 | 11 |
| Total, serious adverse events | Somatropin (Without Previous Somatropin Exposure) | 2 | 10 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 29029101 | 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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Somatropin (With Previous Somatropin Exposure) vs Somatropin (Without Previous Somatropin Exposure): 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/NCT00174291
GET https://conductscience.org/api/trials/v1/NCT00174291/results?page=2