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

Study at a glance

From the registry record, last updated by the sponsor on 15 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

Genentech National Cooperative Growth Study (NCGS) Post-Marketing Surveillance Program For Nutropin AQ® (Somatropin [rDNA Origin] Injection), Nutropin® (Somatropin [rDNA Origin] for Injection), and Protropin® (Somatrem for Injection)

ClinicalTrials.gov ID

NCT00097539

Acronym / sponsor ID

85-036

Conditions

Growth Disorders

Keywords

Pediatric growth disorders

Study type

Observational

Recruitment status

Completed

Enrolment

65,205 participants (actual)

Lead sponsor

Genentech, Inc.Industry (pharma, biotech, devices)

Study start

Oct 1985

Primary completion

Jun 2010 (actual)

Study completion

Jun 2010 (actual)

First posted

25 Nov 2004 (estimated)

Results

Posted 15 Feb 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model

Cohort

Time perspective

Prospective

Number of arms

1

Who may qualify

Sex

All

Healthy volunteers

Not accepted

Age groups

Child, Adult, Older adult

Study population

Participants initiating therapy with Genentech GH products 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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

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

   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.

3. 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.

4. 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.

5. 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).

Results and safety

Loading the posted results from ClinicalTrials.gov…

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2017.
• Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.