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

Completed

• Conditions: Growth Disorders
• Interventions: Biological: Somatrem; Biological: Somatropin

• Registration Number: NCT00097539
• Lead Sponsor: Genentech, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 1985-10
• Study First Submitted: 2004-11-24
• Study First Submitted QC: 2004-11-24
• Study First Posted: 2004-11-25
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Results First Submitted: 2016-10-13
• Status Verified: 2016-12
• Results First Submitted QC: 2016-12-21
• Last Update Submitted: 2016-12-21
• Results First Posted: 2017-02-15
• Last Update Posted: 2017-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65205

Inclusion Criteria

• Participants with open epiphyses
• Children of either sex who are treated with Nutropin Depot, Nutropin AQ, Nutropin, or Protropin for the treatment of growth failure
• Participants who are willing to keep follow up appointments throughout the study participation

Exclusion Criteria

• Participants treated with a non-Genentech GH preparation
• Participants with closed epiphyses
• Participants with active neoplasia

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants With Growth Disorders	Somatrem	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.
Participants With Growth Disorders	Somatropin	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.

Primary Outcome Measures

Name	Time	Method
First Year Annualized Growth Rate	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	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.
Near Adult Height (NAH)	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).
Number of Participants Who Died	From October 1985 to June 2010 (overall approximately 24 years and 9 months)
Third Year Annualized Growth Rate	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.