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

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 (</=) 8 years (females) or </= 10 years (males) as 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) </= -1.5 (</= 5th percentile) for IGHD participants; Ht SDS </= -2.25 (</= 1.2 percentile) for ISS participants

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