rhGH and rhIGF-1 Combination Therapy in Children With Short Stature Associated With IGF-1 Deficiency

Inclusion Criteria: * Parents or legally authorized representatives must give signed informed consent before any trial-related activities * IGF-1 SDS of ≤ -1 for age and gender * Short stature, as defined by a height SDS of ≤ -2 for age and gender * Chronological age ≥ 5 years * Bone age ≤ 11 years in boys and ≤ 9 years in girls * GH sufficiency, defined as a maximal stimulated GH response of greater than or equal to 10 ng/mL at Visit 2 (note: upon approval of the Medical Monitor, the result of a prior GH stimulation test may satisfy this requirement). * Prepubertal status * Adequate nutrition as evidenced by a body mass index (BMI) greater than or equal to the 5th percentile for age and gender Exclusion Criteria: * Severe Primary IGFD (defined as height and IGF-1 SDS ≤ 3, and stimulated GH response greater than or equal to 10 ng/mL) * Prior or current use of medications with the potential to alter growth patterns including GH, IGF-1, IGFBP-3, gonadotrophin agonists (e.g., Lupron), aromatase inhibitors, androgens and estrogens * Known or suspected allergy to rhGH, rhIGF-1 or a constituent of their formulations * Current use of medications for attention deficit disorder * A chronic health condition that requires anti-inflammatory steroids or daily medication unless approved by the Medical Monitor