Trial · Observational
CompletedPhase not statedResults postedRegistry data1 trial · 1 completed · 1 with posted results
National Cooperative Growth Study (NCGS): A Post-marketing Surveillance Program for Nutropin, Nutropin AQ, Nutropin Depot, and Protropin
NCT00097539Oct 1985 to Jun 2010
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The purpose of this multicenter, open-label, observational, post-marketing surveillance study is to collect long term safety and efficacy information on growth hormone (GH) products: Protropin (somatrem for injection), Nutropin (somatropin for injection), Nutropin AQ (somatropin for injection), and Nutropin Depot (somatropin for injectable suspension) in the treatment of pediatric growth disorders for which GH is prescribed.
Other
Participants With Growth Disorders
Participants initiating therapy with Genentech GH products: Protropin (somatrem for injection), Nutropin (somatropin for injection), Nutropin AQ (somatropin for injection), and Nutropin Depot (somatropin for injectable suspension) for the treatment of pediatric growth disorders as determined by their physician and who have consented to participate in the NCGS will be enrolled in the study and will be followed throughout their course of treatment, or until withdrawal from the NCGS.
Outcomes the sponsor listed as primary.
Number of Participants Who Died
Time frame · From October 1985 to June 2010 (overall approximately 24 years and 9 months)
First Year Annualized Growth Rate
Time frame · Year 1
Annualized growth rates are expressed as centimeters per year (cm/yr), computed as the change in height (centimeters) divided by the change in age (years). Growth rates were calculated from the date of the first injection (baseline/ enrollment) to the visit closest to 365\*1 days after baseline. Visits within 90 days of 365\*1 days after baseline may be used. If multiple visits within 90 days were reported then the visit closest to 365\*1 days was used. Growth rates less than (\<) -1 or greater than (\>) 30 cm/yr were excluded. Growth rates from -1 to 0 were set to 0 cm/yr. Growth rates are summarized by etiology group and gender. Only those participants who had non-missing 1-year growth rate data were included in the analysis.
Second Year Annualized Growth Rate
Time frame · Year 2
Annualized growth rates are expressed as cm/yr, computed as the change in height (centimeters) divided by the change in age (years). Growth rates were calculated from the date of the visit closest to 365 days after baseline to the visit closest to 730 days. Visits within 90 days of 365 and 730 days after baseline may be used. If multiple visits within 90 days were reported then the visit closest to 365 or 730 days was used. Growth rates \<-1 or \>30 cm/yr were excluded. Growth rates from -1 to 0 were set to 0 cm/yr. Growth rates are summarized by etiology group and gender. Only those participants who had non-missing second-year growth rate data were included in the analysis.
Third Year Annualized Growth Rate
Time frame · Year 3
Annualized growth rates are expressed as cm/yr, computed as the change in height (centimeters) divided by the change in age (years). Growth rates were calculated from the date of the visit closest to 730 days after baseline to the visit closest to 1095 days. Visits within 90 days of 730 and 1095 days after baseline may be used. If multiple visits within 90 days were reported then the visit closest to 730 or 1095 days was used. Growth rates \<-1 or \>30 cm/yr were excluded. Growth rates from -1 to 0 were set to 0 cm/yr. Growth rates are summarized by etiology group and gender. Only those participants who had non-missing third-year growth rate data were included in the analysis.
Near Adult Height (NAH)
Time frame · From October 1985 to June 2010 (overall approximately 24 years and 9 months)
Heights were standardized with height standardized deviation scores (SDS) to enable height comparisons across ages and sexes using methods and height standards found at: http://www.cdc.gov/growthcharts/cdc\_charts.htm. NAH were calculated overall and by etiology groups for participants who had both a non-missing value available height z-score and a non-missing enrollment height (EH) SDS, as well as for participants with 3 or more years of GH therapy (GHT ≥3y).
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (participants) |
|---|---|
| Idiopathic Growth Hormone Deficiency (IGHD) | 14 |
| Organic GHD | 96 |
| Idiopathic Short Stature (ISS) | 4 |
| Turner Syndrome | 7 |
| Renal Disease | 23 |
| Other Etiology | 38 |
| Undefined Etiology | 1 |
| Group | Value (cm/yr) | Spread |
|---|---|---|
| Idiopathic Growth Hormone Deficiency (IGHD) | 9.5 | 2.7 |
| Organic GHD | 10.3 | 4.1 |
| Idiopathic Short Stature (ISS) | 8.6 | 2.2 |
| Turner Syndrome | not posted | – |
| Renal Disease | 8.9 | 3.6 |
| Other Etiology | 9.5 | 3.5 |
| Undefined Etiology | 9.8 | 4.3 |
| Group | Value (cm/yr) | Spread |
|---|---|---|
| Idiopathic Growth Hormone Deficiency (IGHD) | 7.7 | 1.8 |
| Organic GHD | 8.0 | 2.5 |
| Idiopathic Short Stature (ISS) | 7.3 | 1.6 |
| Turner Syndrome | not posted | – |
| Renal Disease | 7.2 | 2.4 |
| Other Etiology | 7.5 | 2.2 |
| Undefined Etiology | 7.7 | 2.4 |
| Group | Value (cm/yr) | Spread |
|---|---|---|
| Idiopathic Growth Hormone Deficiency (IGHD) | 7.0 | 1.7 |
| Organic GHD | 7.1 | 2.2 |
| Idiopathic Short Stature (ISS) | 6.6 | 1.6 |
| Turner Syndrome | not posted | – |
| Renal Disease | 6.2 | 2.4 |
| Other Etiology | 6.8 | 1.9 |
| Undefined Etiology | 6.5 | 1.7 |
| Group | Value (SDS) | Spread |
|---|---|---|
| Idiopathic Growth Hormone Deficiency (IGHD) | -0.9 | 1.1 |
| Organic GHD | -1.1 | 1.4 |
| Idiopathic Short Stature (ISS) | -1.2 | 1.0 |
| Turner Syndrome | -2.0 | 1.0 |
| Renal Disease | -2.0 | 1.5 |
| Other Etiology | -1.5 | 1.3 |
| Undefined Etiology | -1.3 | 1.2 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Idiopathic Growth Hormone Deficiency (IGHD)Participants who meet any one of the following definitions: Documented IGHD; Undocumented IGHD; Presumed IGHD. | – | 322 / 27,286 | 949 / 27,286 |
| Organic GHDParticipants with conditions that have a direct effect on the ability of the pituitary gland to modulate GH production, including craniopharyngioma, CNS tumors, CNS trauma, irradiation, septo-optic dysplasia, and effects of treatments given to participants with leukemia. Inclusion was determined by enrollment form etiology and medical history checkboxes coupled with examination of all participants text. | – | 595 / 9356 | 523 / 9356 |
| Idiopathic Short Stature (ISS)Participants must have had a stimulation result of \>/=10 ng/mL and/or other identifiable relevant medical text related to ISS. Participants without any identifiable criterion for assignation elsewhere, coupled with a stimulation result of \>/=10 ng/mL were assigned to this group. ISS participant may have been Documented ISS, Undocumented ISS, or Presumed ISS, based on text criteria and GH stimulation result of \>/=10 ng/mL. | – | 100 / 12,519 | 385 / 12,519 |
| Turner SyndromeParticipants were assigned to this group, based on medical review of selected participants text, karyotype data, and medical history in cooperation with the NCGS medical advisor. | – | 119 / 5651 | 328 / 5651 |
| Renal DiseaseParticipants with CRI or ESRD prior to transplantation as indicated by the CRI/ESRD checkbox on the current NCGS enrollment form or Chronic Renal Disease checkbox (RENAL) from older versions. A search for equivalent terminology in the medical text was also done. | – | 141 / 2144 | 101 / 2144 |
| Other EtiologyThe other group represents a heterogeneous mix of participants. Classification in this grouping was determined by examination of enrollment form etiology and medical history checkboxes coupled with examination of participant medical text for selected conditions. Participants with a variety of congenital and/or genetic syndromes, such as Noonan syndrome or Prader-Willi syndrome, were largely included in this classification. | – | 255 / 8010 | 357 / 8010 |
| Undefined EtiologyA participants meeting none of the criteria above was classified as Undefined. These included participants with no medically relevant checkbox, no relevant medical text noted on the enrollment or follow-up forms, and no stimulation result available. | – | 4 / 239 | 7 / 239 |
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