Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
First Subject Screened: 12 January 2005. Last Subject Completed: 14 January 2009. 12 investigators screened subjects, 1 did not enroll any subject. 89 subjects were screened, 41 were ineligible, 3 declined treatment and 45 were treated and analyzed.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Screening consisted of two-staged clinic visits for up to 6 weeks, and included the following evaluations: medical history, complete physical examination, measurements of serum IGF-1 and IGF-1 binding proteins (IGFBP 1, IGFBP 2 and IGFBP-3), GH binding protein, Acid-labile subunit, GH stimulation test.

Reporting Groups

	Description
rhIGF-1 QD	During the treatment phase, subjects received subcutaneous (SC) injections of rhIGF-1 at an initial dose of 60 µg/kg QD, with subsequent dose adjustments made in order to achieve the target serum IGF-1 concentration for the subject’s age and sex.

Participant Flow:   Overall Study

	rhIGF-1 QD
STARTED	45
COMPLETED	30
NOT COMPLETED	15
Adverse Event	1
Lost to Follow-up	4
Patient/Parent Decision	7
other	1
Non-compliance	2

Reporting Groups

	Description
rhIGF-1 QD	During the treatment phase, subjects received subcutaneous (SC) injections of rhIGF-1 at an initial dose of 60 µg/kg QD, with subsequent dose adjustments made in order to achieve the target serum IGF-1 concentration for the subject’s age and sex.

Baseline Measures

	rhIGF-1 QD
Number of Participants   [units: participants]	45
Age   [units: years] Mean ± Standard Deviation	8.7  ± 2.8
Gender   [units: participants]
Female	7
Male	38
Race/Ethnicity, Customized   [units: participants]
Black	1
Hispanic	12
White	31
Other	1
Body Mass Index SD Score   [units: SDs] Mean ± Standard Deviation	-0.4  ± 0.7
Bone Age   [units: years] Mean ± Standard Deviation	7.2  ± 2.6
Height SD Score   [units: SDs] Mean ± Standard Deviation	-2.7  ± 0.6
IGF Binding Protein-3 SD Score   [units: SDs] Mean ± Standard Deviation	-0.7  ± 1.0
IGF-1 SD Score   [units: SDs] Mean ± Standard Deviation	-2.6  ± 0.5
Maximum Stimulated GH   [units: ng/mL] Mean ± Standard Deviation	20.5  ± 9.9
Weight SD Score   [units: SDs] Mean ± Standard Deviation	-2.3  ± 0.7

1.  Primary:

Height Velocity Over the Study Period 0 - 34 Weeks [Intent to Treat Population]   [ Time Frame: 34 weeks ]

2.  Primary:

Height Velocity Over the Study Period 34 - 86 Weeks [Intent to Treat Population]   [ Time Frame: Weeks 34 to 86 ]

3.  Secondary:

Changes in Height Standard Deviation (SD) Score Over the Study Period 0 - 34 Weeks [Intent to Treat Population]   [ Time Frame: Weeks 0 - 34 ]

4.  Secondary:

Changes in Height Standard Deviation (SD) Score Over the Study Period 34 - 86 Weeks   [ Time Frame: Weeks 34 - 86 ]

5.  Secondary:

Bone Age - Change From Pretreatment Minus Change in Chronological Age Over the Study Period 0 - 86 Weeks [Intent to Treat Population]   [ Time Frame: Weeks 0 - 86 ]

6.  Secondary:

Percent Changes in Serum Concentration of Insulin-like Growth Factor Binding-1 (IGFBP-1) From Baseline to Week 86   [ Time Frame: 86 weeks ]

7.  Secondary:

Percent Changes in Serum Concentration of Insulin-like Growth Factor Binding-2 (IGFBP-2) From Baseline to Week 86   [ Time Frame: 86 weeks ]

8.  Secondary:

Percent Changes in Serum Concentration of Insulin-like Growth Factor Binding-3 (IGFBP-3) From Baseline to Week 86   [ Time Frame: 86 weeks ]

9.  Secondary:

Percent Changes in Serum Concentration of Acid Labile Subunit (ALS) From Baseline to Week 86   [ Time Frame: 86 weeks ]

10.  Post-Hoc:

Increase in Height Velocity Over the Study Period 0 - 34 Weeks [Completers]   [ Time Frame: Weeks 0 -34 ]

11.  Post-Hoc:

Increase in Height Velocity Over the Study Period 34 - 86 Weeks [Completers]   [ Time Frame: Weeks 34 - 86 ]

12.  Secondary:

rhIGF-1 Doses Required to Achieve the Serum IGF-1 Targets With Measures Taken at Each Study Visit   [ Time Frame: 34, 52 and 86 weeks ]