Overview

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

Status:
Terminated
Trial end date:
2011-08-01
Target enrollment:
0
Participant gender:
All
Summary
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).
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Genentech, Inc.
Criteria
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