Trial · NCT01088412
Observational Study of Somatropin Treatment in Children
NCT01088412, Completed, Eli Lilly and Company; results first posted 2019-05-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Observational Study of Somatropin Treatment in Children. Trials, record NCT01088412. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01088412
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Observational Study of Somatropin Treatment in Children
- NCT number
- NCT01088412
- Status
- Completed
- Enrollment
- 22,845 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Growth Hormone (GH) Deficiency, Short Stature Homeobox Containing Gene (SHOX) Deficiency, SHOX Deficiency-related Disorder, Non-GH-deficient Growth Disorders
- Interventions
- Somatropin (recombinant deoxyribonucleic acid [rDNA] origin)
- First posted
- 2010-03-17
- Last updated
- 2019-05-13
- Results first posted
- 2019-05-13
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Type 2 Diabetes Mellitus in GH-treated Participants | Year 15 | |
| Primary | Primary Malignancies in Participant Without Previous Cancer History | Year 15 | Due to the small number of participants involved, untreated and unknown treatment groups, data was not provided and could not be calculated. |
| Primary | Final Height (FH) Gain by Diagnostic Group | Baseline through Year 15 | The standard deviation score (SDS) reports the number of standard deviations from the mean for age and sex for an individual measurement (normal range is -2 to +2 SDS). Height SDS is derived by subtracting the population mean from individual's height value and then dividing that difference by the population standard deviation. Greater height SDS values indicate greater height. Due to the small number of participants involved, untreated and unknown treatment groups, data was not provided and could not be calculated. |
| Secondary | Percentage of Participants With Defects in Genes Associated With Pituitary Development | Baseline through Year 15 | Percentage of participants with genetic defects associated with pituitary development. Genes included but were not limited to GH1, Growth hormone releasing hormone receptor (GHRHR), Homeobox gene expressed in embryonic stem cells (HESX1), LIM homeobox 3 (LHX3), POU domain, class 1, transcription factor 1 (POU1F1), and Prophet of Pit1 (PROP1). |
| Secondary | Predicted First Year Height Gain Versus Actual First Year Height Gain | Baseline through Year 15 | The value for predicted and observed is of limited bearing, it is how each participant's predicted versus observed height gain compare and this is best estimated by the R-squared. An estimation parameter would not be a correct format for the R2 data. R2 can take value between 0 and 1 with values closer to 0 representing a poor fit while values closer to 1 representing a perfect fit |
| Secondary | Change From Baseline to Final Height in Anthropometric Measures for Participants With SHOX Deficiency | Baseline, Year 15 | |
| Secondary | Percentage of Participants With Recurrent Neoplasms and Second Neoplasms in Childhood Cancer Survivors | Baseline through Year 15 | Percentage of participants with recurrence/progression of primary neoplastic disease and/or development of secondary neoplasms in childhood cancer survivors. |
| Secondary | Percentage of Participants With De Novo Neoplasms | Baseline through Year 15 | Percentage of participants with the development of de novo neoplastic disease with no history of prior neoplasia. |
| Secondary | Diabetes Mellitus (DM) in Somatropin-Treated Children With Different Short Stature Diagnoses | Baseline through Year 15 |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Type 2 Diabetes Mellitus in GH-treated Participants | Year 15 | All treated participants with available age and calculable follow-up time. The treated participants were not compared with untreated but with rates from general population registries. The untreated participants predominantly contained neoplasm or SHOX deficient diagnoses, therefore had significant baseline differences from treated participants. | Incident Cases | NUMBER |
| PRIMARY | Primary Malignancies in Participant Without Previous Cancer History | Year 15 | All treated participants with available age, gender, and at least one follow-up excluding participants with previous cancer cases. Due to the small number of participants involved, untreated and unknown treatment groups, data was not provided and could not be calculated. | Incident Cases | NUMBER |
| PRIMARY | Final Height (FH) Gain by Diagnostic Group | Baseline through Year 15 | All treated participants who reached final height (at least 1: closed epiphyses, height velocity \<2 centimeters per year, or last bone age \>14 years \[girls\] or \>16 years \[boys\]) with baseline height SDS and final height available. Data was not provided for untreated and unknown treatment groups, and could not be calculated. | standard deviation score | MEAN |
| SECONDARY | Percentage of Participants With Defects in Genes Associated With Pituitary Development | Baseline through Year 15 | All SME participants (including treated, untreated, and unknown groups) with available results of DNA (deoxyribonucleic acid) analysis available and GHD diagnosis. | percentage of participants | NUMBER |
| SECONDARY | Predicted First Year Height Gain Versus Actual First Year Height Gain | Baseline through Year 15 | All participants with predicted and actual first year height gain available and TS or GHD diagnosis. Data was not provided for untreated and unknown treatment groups, and could not be calculated. | R Squared | NUMBER |
| SECONDARY | Change From Baseline to Final Height in Anthropometric Measures for Participants With SHOX Deficiency | Baseline, Year 15 | All SHOX-D Participants, GH-treated, with available height SDS at baseline and final height. Data was not provided for untreated and unknown treatment groups, and could not be calculated. | standard deviation score | MEAN |
| SECONDARY | Percentage of Participants With Recurrent Neoplasms and Second Neoplasms in Childhood Cancer Survivors | Baseline through Year 15 | All SME, treated participants with previous neoplastic disease and at least one follow-up visit. Data was not provided for untreated and unknown treatment groups, and could not be calculated. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With De Novo Neoplasms | Baseline through Year 15 | All SME, GH-treated participants with at least one follow-up visit. Data was not provided for untreated and unknown treatment groups, and could not be calculated. | percentage of participants | NUMBER |
| SECONDARY | Diabetes Mellitus (DM) in Somatropin-Treated Children With Different Short Stature Diagnoses | Baseline through Year 15 | All treated participants with available age and calculable follow-up time, and diabetes mellitus (DM), type 1 diabetes mellitus (T1) or type 2 diabetes mellitus (T2). Data was not provided for untreated and unknown treatment groups, and could not be calculated. | Incident Cases | NUMBER |
Source ClinicalTrials.gov
Results by group69
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Type 2 Diabetes Mellitus in GH-treated Participants | Treated | Ages 0 to 9 | 1 | Incident Cases | |
| Type 2 Diabetes Mellitus in GH-treated Participants | Treated | Ages 10 to 14 | 9 | Incident Cases | |
| Type 2 Diabetes Mellitus in GH-treated Participants | Treated | Ages 15 to 19 | 8 | Incident Cases | |
| Primary Malignancies in Participant Without Previous Cancer History | Treated | 14 | Incident Cases | ||
| Final Height (FH) Gain by Diagnostic Group | Treated | All Baseline Height | -2.42 | Standard Deviation 1.01 | standard deviation score |
| Final Height (FH) Gain by Diagnostic Group | Treated | All Final Height | -1.18 | Standard Deviation 1.12 | standard deviation score |
| Final Height (FH) Gain by Diagnostic Group | Treated | All Final Height Gain | 1.24 | Standard Deviation 1.08 | standard deviation score |
| Final Height (FH) Gain by Diagnostic Group | Treated | GHD Baseline Height | -2.35 | Standard Deviation 1.04 | standard deviation score |
| Final Height (FH) Gain by Diagnostic Group | Treated | GHD Final Height | -0.96 | Standard Deviation 1.12 | standard deviation score |
| Final Height (FH) Gain by Diagnostic Group | Treated | GHD Final Height Gain | 1.39 | Standard Deviation 1.14 | standard deviation score |
1 to 10 of 69Source ClinicalTrials.gov
See all 69 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treated | 22,311 | |
| Overall Study | STARTED | Untreated | 457 | |
| Overall Study | STARTED | 77 | ||
| Overall Study | Safety Modified Evaluable (SME) | Treated | 22,294 | |
| Overall Study | Safety Modified Evaluable (SME) | Untreated | 456 | |
| Overall Study | Safety Modified Evaluable (SME) | 0 | ||
| Overall Study | SME With at Least 1 Follow Up (FU) | Treated | 21,178 | |
| Overall Study | SME With at Least 1 Follow Up (FU) | Untreated | 306 | |
| Overall Study | SME With at Least 1 Follow Up (FU) | 0 | ||
| Overall Study | SME+ >= 1 FU and Unknown Arm | Treated | 21,177 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events1,551
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 | Turner's syndrome | Congenital, familial and genetic disorders | Treated | 19 | 8,458 | 19 |
| other | Turner's syndrome | Congenital, familial and genetic disorders | Untreated | 0 | 306 | 0 |
| other | Turner's syndrome | Congenital, familial and genetic disorders | 0 | 40 | 0 | |
| other | Adrenal insufficiency | Endocrine disorders | Treated | 99 | 21,177 | 100 |
| other | Adrenal insufficiency | Endocrine disorders | Untreated | 3 | 306 | 3 |
| other | Adrenal insufficiency | Endocrine disorders | 0 | 40 | 0 | |
| other | Autoimmune thyroiditis | Endocrine disorders | Treated | 48 | 21,177 | 50 |
| other | Autoimmune thyroiditis | Endocrine disorders | Untreated | 2 | 306 | 2 |
| other | Autoimmune thyroiditis | Endocrine disorders | 0 | 40 | 0 | |
| other | Delayed puberty | Endocrine disorders | Treated | 192 | 21,177 | 193 |
1 to 10 of 1,551Source ClinicalTrials.gov
See all 1,551 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treated | ||
| Total, all-cause mortality | Untreated | ||
| Total, all-cause mortality | |||
| Total, other adverse events | Treated | 6,180 | 21,177 |
| Total, other adverse events | Untreated | 126 | 306 |
| Total, other adverse events | 0 | 40 | |
| Total, serious adverse events | Treated | 547 | 21,177 |
| Total, serious adverse events | Untreated | 14 | 306 |
| Total, serious adverse events | 0 | 40 |
Source ClinicalTrials.gov
Papers6
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 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/NCT01088412
GET https://conductscience.org/api/trials/v1/NCT01088412/results?page=2