Trial · NCT00174187
Treatment With Recombinant Human Growth Hormone (GH) in Children With Short Stature Secondary to a Long Term Corticoid Therapy
NCT00174187, Phase 3, Terminated, Pfizer; results first posted 2012-12-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Treatment With Recombinant Human Growth Hormone (GH) in Children With Short Stature Secondary to a Long Term Corticoid Therapy. Trials, record NCT00174187. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00174187
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Treatment With Recombinant Human Growth Hormone (GH) in Children With Short Stature Secondary to a Long Term Corticoid Therapy
- NCT number
- NCT00174187
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 30 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
Results for secondary and other pre-specified endpoints (except IGF-1) are reported for only up to 3 years because data beyond Year 3 was not summarized as the study was terminated due to Good Clinical Practice (GCP) non-compliance issues.
Source ClinicalTrials.gov
Registered outcomes30
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 According to Chronological Age (SDS/CA) at Year 3 | Baseline, Year 3 | Height was measured using a wall mounted device (example, Harpenden stadiometer). Height SDS/CA 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 According to Chronological Age (SDS/CA) at Final Height | Baseline, when final height was reached (assessed up to Year 11) | Height was measured using a wall mounted device (example, Harpenden stadiometer). Height SDS/CA 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 Weight Standard Deviation Score (SDS) at Final Height | Baseline, when final height was reached (assessed up to Year 11) | Body weight was measured using a balance scale. Weight SDS was obtained by measuring the weight, subtracting age- and gender-appropriate mean weight and dividing the result by standard deviation of that mean (as obtained from 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 | Puberty Stage at Final Height | When final height was reached (assessed up to Year 11) | Pubertal stage (graded from I to V for breast development and pubic hair development) according to the Tanner's method was collected. A low stage (Stage I) corresponds to a pre-pubertal stage and a high stage (Stage V) to an adult stage. |
| Secondary | Bone Age | Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 | Bone age was determined by the Greulich and Pyle method using left wrist and hand X-ray. |
| Secondary | Lean Body Mass | Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 | Lean body mass, a measurement of body composition, was assessed by Dual Energy X-ray Absorptiometry (DEXA) scan. |
| Secondary | Annual Percent Change in Lean Body Mass at Year 1, 2 and 3 | Baseline, Year 1, 2, 3 | Lean body mass, a measurement of body composition, was assessed by DEXA scan. Annual percent change: (Lean body mass at current year minus lean body mass at previous year) divided by lean body mass at previous year, multiplied by 100. |
| Secondary | Percent Change From Baseline in Lean Body Mass at Year 3 | Baseline, Year 3 | Lean body mass, a measurement of body composition, was assessed by DEXA scan. Percent change: (Lean body mass at Year 3 minus lean body mass at baseline) divided by lean body mass at baseline, multiplied by 100. |
| Secondary | Lean Body Mass as Percentage of Total Weight | Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 | Lean body mass, a measurement of body composition, was assessed by DEXA scan. |
| Secondary | Lean Body Mass Standard Deviation Score According to Chronological Age (SDS/CA) | Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 | Lean body mass was assessed by DEXA scan. Lean body mass SDS/CA was obtained by measuring lean body mass, subtracting the chronological age- and gender-appropriate mean lean body mass 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. |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 registered outcomesOutcomes30
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 According to Chronological Age (SDS/CA) at Year 3 | Baseline, Year 3 | Full Analysis Set (FAS) up to Year 3: included all participants who had at least 1 post-baseline height measurement and were treated with the study drug for at least 1 year. | Standard Deviation Score (SDS) | MEDIAN |
| PRIMARY | Change From Baseline in Height Standard Deviation Score According to Chronological Age (SDS/CA) at Final Height | Baseline, when final height was reached (assessed up to Year 11) | FAS- after Year 3: included all participants who received at least 1 dose of the study treatment and who had at least 1 post-baseline height measurement. Here, 'n' signifies those participants who were evaluable for this measure at given time points. | SDS | MEDIAN |
| PRIMARY | Change From Baseline in Weight Standard Deviation Score (SDS) at Final Height | Baseline, when final height was reached (assessed up to Year 11) | FAS- after Year 3: included all participants who received at least one dose of the study treatment and who had at least one post-baseline height measurement. Here, 'n' signifies those participants who were evaluable for this measure at given time point. | SDS | MEDIAN |
| PRIMARY | Puberty Stage at Final Height | When final height was reached (assessed up to Year 11) | FAS- after Year 3: included all participants who received at least one dose of study treatment and who had at least one post-baseline height measurement. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants who were evaluable for given components of puberty assessment. | participants | NUMBER |
| SECONDARY | Bone Age | Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 | FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively. | years | MEDIAN |
| SECONDARY | Lean Body Mass | Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 | FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively. | kilogram (kg) | MEDIAN |
| SECONDARY | Annual Percent Change in Lean Body Mass at Year 1, 2 and 3 | Baseline, Year 1, 2, 3 | FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively. | percent change | MEDIAN |
| SECONDARY | Percent Change From Baseline in Lean Body Mass at Year 3 | Baseline, Year 3 | FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | percent change | MEDIAN |
| SECONDARY | Lean Body Mass as Percentage of Total Weight | Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 | FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively. | percentage of total weight | MEDIAN |
| SECONDARY | Lean Body Mass Standard Deviation Score According to Chronological Age (SDS/CA) | Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 | FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively. | SDS | MEDIAN |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 outcomesResults by group211
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 According to Chronological Age (SDS/CA) at Year 3 | Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis) | Baseline | -3.6 | Inter-Quartile Range -5.1 to -2.3 | Standard Deviation Score (SDS) |
| Change From Baseline in Height Standard Deviation Score According to Chronological Age (SDS/CA) at Year 3 | Somatropin- Up To Year 3 (Nephrotic Syndrome) | Baseline | -2.5 | Inter-Quartile Range -2.8 to -2.2 | Standard Deviation Score (SDS) |
| Change From Baseline in Height Standard Deviation Score According to Chronological Age (SDS/CA) at Year 3 | Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis) | Change at Year 3 | 0.2 | Inter-Quartile Range -1.5 to 1.8 | Standard Deviation Score (SDS) |
| Change From Baseline in Height Standard Deviation Score According to Chronological Age (SDS/CA) at Year 3 | Somatropin- Up To Year 3 (Nephrotic Syndrome) | Change at Year 3 | 1.1 | Inter-Quartile Range 0.8 to 1.5 | Standard Deviation Score (SDS) |
| Change From Baseline in Height Standard Deviation Score According to Chronological Age (SDS/CA) at Final Height | Somatropin- After Year 3 | Baseline (n = 21) | -2.86 | Full Range -5.61 to -1.00 | SDS |
| Change From Baseline in Height Standard Deviation Score According to Chronological Age (SDS/CA) at Final Height | Somatropin- After Year 3 | Change at Final Height (n = 4) | 0.71 | Full Range 0.27 to 3.08 | SDS |
| Change From Baseline in Weight Standard Deviation Score (SDS) at Final Height | Somatropin- After Year 3 | Baseline (n = 21) | -1.53 | Full Range -4.77 to 2.64 | SDS |
| Change From Baseline in Weight Standard Deviation Score (SDS) at Final Height | Somatropin- After Year 3 | Change at Final Height (n = 4) | -0.43 | Full Range -1.37 to 1.09 | SDS |
| Puberty Stage at Final Height | Somatropin- After Year 3 | Pubic hair: Stage I (n=4) | 0 | participants | |
| Puberty Stage at Final Height | Somatropin- After Year 3 | Pubic hair: Stage II (n=4) | 0 | participants |
1 to 10 of 211Source ClinicalTrials.gov
See all 211 results by groupParticipant flow30
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Period 1 (up to 3 Years) | STARTED | Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis) | 15 | |
| Period 1 (up to 3 Years) | STARTED | Somatropin- Up To Year 3 (Nephrotic Syndrome) | 15 | |
| Period 1 (up to 3 Years) | STARTED | Somatropin- After Year 3 | 0 | |
| Period 1 (up to 3 Years) | COMPLETED | Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis) | 15 | |
| Period 1 (up to 3 Years) | COMPLETED | Somatropin- Up To Year 3 (Nephrotic Syndrome) | 11 | |
| Period 1 (up to 3 Years) | COMPLETED | Somatropin- After Year 3 | 0 | |
| Period 1 (up to 3 Years) | NOT COMPLETED | Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis) | 0 | |
| Period 1 (up to 3 Years) | NOT COMPLETED | Somatropin- Up To Year 3 (Nephrotic Syndrome) | 4 | |
| Period 1 (up to 3 Years) | NOT COMPLETED | Somatropin- After Year 3 | 0 | |
| Between Period 1 and Period 2 | STARTED | Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis) | 0 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 participant flowAdverse events399
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 | Hypercoagulation | Blood and lymphatic system disorders | Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis) | 0 | 15 | |
| other | Hypercoagulation | Blood and lymphatic system disorders | Somatropin- Up To Year 3 (Nephrotic Syndrome) | 1 | 15 | |
| other | Hypercoagulation | Blood and lymphatic system disorders | Somatropin- After Year 3 | 0 | 21 | |
| other | Angina pectoris | Cardiac disorders | Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis) | 1 | 15 | |
| other | Angina pectoris | Cardiac disorders | Somatropin- Up To Year 3 (Nephrotic Syndrome) | 0 | 15 | |
| other | Angina pectoris | Cardiac disorders | Somatropin- After Year 3 | 2 | 21 | |
| other | Auricular perichondritis | Ear and labyrinth disorders | Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis) | 1 | 15 | |
| other | Auricular perichondritis | Ear and labyrinth disorders | Somatropin- Up To Year 3 (Nephrotic Syndrome) | 0 | 15 | |
| other | Auricular perichondritis | Ear and labyrinth disorders | Somatropin- After Year 3 | 1 | 21 | |
| other | Deafness | Ear and labyrinth disorders | Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis) | 0 | 15 |
1 to 10 of 399Source ClinicalTrials.gov
See all 399 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis) | ||
| Total, all-cause mortality | Somatropin- Up To Year 3 (Nephrotic Syndrome) | ||
| Total, all-cause mortality | Somatropin- After Year 3 | ||
| Total, other adverse events | Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis) | 13 | 15 |
| Total, other adverse events | Somatropin- Up To Year 3 (Nephrotic Syndrome) | 14 | 15 |
| Total, other adverse events | Somatropin- After Year 3 | 21 | 21 |
| Total, serious adverse events | Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis) | 13 | 15 |
| Total, serious adverse events | Somatropin- Up To Year 3 (Nephrotic Syndrome) | 14 | 15 |
| Total, serious adverse events | Somatropin- After Year 3 | 19 | 21 |
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 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.
GET https://conductscience.org/api/trials/v1/NCT00174187
GET https://conductscience.org/api/trials/v1/NCT00174187/registered?page=2