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 Scottsdale Arizona

Scottsdale, Arizona

from

Scottsdale, AZ