National Cooperative Growth Study (NCGS): A Post-marketing Surveillance Program for Nutropin, Nutropin AQ, Nutropin Depot, and Protropin

Browse trials for

• Growth Disorders 167

Keywords

• Pediatric growth disorders

Growth Disorders

167 studies on the registry are indexed under Growth Disorders; 24 are open to participants now.

This study's enrollment of 65,205 is above the median of 205 across 67 observational studies indexed under Growth Disorders.

Lead sponsor

Genentech, Inc. is the lead sponsor of 507 studies on the registry; 23 are open to participants now.

Of its 90 completed or terminated interventional studies of FDA-regulated products, 50 (56%) have results posted.

Study population

Groups and cohorts

• 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.

  Biological: Somatrem · Biological: Somatropin

Interventions

• BiologicalSomatrem

  Also known as: Protropin

• BiologicalSomatropin

  Also known as: Nutropin®, Nutropin AQ®, Nutropin Depot™

Primary outcomes

1. Number of Participants Who Died

   Time frame: From October 1985 to June 2010 (overall approximately 24 years and 9 months)

2. First Year Annualized Growth Rate

   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.

   Time frame: Year 1

3. Second Year Annualized Growth Rate

   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.

   Time frame: Year 2

4. Third Year Annualized Growth Rate

   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.

   Time frame: Year 3

5. Near Adult Height (NAH)

   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).

   Time frame: From October 1985 to June 2010 (overall approximately 24 years and 9 months)

Baseline characteristics