A Study to Evaluate Growth in Participants Treated With Somatropin (Nutropin) Using NuSpin Device

Status:	Terminated
Conditions:	Endocrine
Therapuetic Areas:	Endocrinology
Healthy:	No
Age Range:	2 - 14
Updated:	6/29/2016
Start Date:	November 2010
End Date:	July 2011

A Phase IV, Open Label, Multicenter, Case-controlled Study of Growth in Patients Using the Nutropin AQ® Nuspin®

This is a phase IV, open label, case-controlled, observational study to evaluate the
age-adjusted cumulative height velocity in pre-pubertal isolated growth hormone deficient
(IGHD) and idiopathic short stature (ISS) participants receiving daily doses of somatropin
(recombinant human growth hormone [rhGH]; Nutropin) using NuSpin device compared to
historical controls from the national cooperative growth study (NCGS).

Inclusion Criteria:

- Bone age less than or equal to ( determined by x-ray of the left hand and wrist obtained within six months before
enrollment

- Prepubertal males and females by physical exam

- Naive to rhGH therapy

- Diagnosis of IGHD or ISS by standard pharmacologic testing and no other discernable
etiology for short stature

- Height standard deviation score (Ht SDS) participants; Ht SDS
Exclusion Criteria:

- Short stature etiologies other than IGHD or ISS

- Participants receiving chronic corticosteroid therapy (greater than [>] 3 months) for
other medical conditions

- Participants with active malignancy or any other condition that the investigator
believes would pose a significant hazard to the participant if rhGH were initiated

- Females with turner syndrome

- Any previous rhGH treatment

- Participation in another simultaneous medical investigation or trial

- Pediatric participants with closed epiphyses

- Participants prescribed rhGH doses outside the variance of NCGS control participant
dosing

We found this trial at

sites

Clinical Trial Facility in Mount Kisco New York

Mount Kisco, New York 10549

from

Mount Kisco, NY