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