Norditropin National Registry

Study ID
STU 122010-126

Cancer Related
No

Healthy Volunteers
No

Study Sites

  • Children's Medical Center-Dallas

Contact
Rita Martin
214-456-9283
rita.barlau@childrens.com

Principal Investigator
Kathryn Sumpter

Summary

The norditropin national Registry is a post-marketing registry of patients using norditropin therapy. The data collected in the norditropin national Registry will thus be observational as no treatment specifics will be mandated.

Primary endpoint:
* Primary endpoint for short-term outcomes is change in height standard deviation score (HSDS).
* Primary endpoint for short-term outcomes in adult patients is waist-to-hip ratio.

Secondary endpoints:
efficacy:
* Short-term: height, height velocity (HV), height velocity standard deviation score (SDS),
predicted adult height (PaH), HSDS for bone age, proportion achieving HSDS [Greater Than] -2 at end of
observational duration period for pediatric patients.weight, weight SDS, body mass index (BMi)and BMi SDS.
* Long-term: final height (or adult height), near-adult height, final height x target height, final
height x PaH, final height SDS x target height SDS, final height SDS x PaH SDS, proportion
achieving HSDS [Greater Than] -2 at final height, height age for pediatric patients.
* Weight, waist circumference, and hip circumference for adult and transition GHD patients
* iGF-i and iGF-i SDS for all patients
Safety:
* adverse reactions (aDRs)
* Serious adverse reactions (SaDRs)
* Medical events of special interest (MeSi)

Participant Eligibility

1. Informed consent obtained before any study-related activities. (Study-related activities are any
procedure related to recording of data according to the protocol)
2. Pediatric or adult patients treated with Norditropin(RegisteredTM) for an appropriate diagnostic indication as
prescribed by their physician
3. Pediatric CHD patients, currently participating in the ANSWER registry, whohave reached adult height and will be discontinuing Norditropin treatment.