Efficacy and Safety of a High Dosage Compared to the Label Dosage of Somatropin in Early Pubertal Stage Children With Growth Hormone Deficiency - Study Results

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Growth Hormone Deficiency
Intervention:	Drug: Somatropin

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
High Dose Somatropin	Somatropin: 0.05 to 0.07 milligram/kilogram/day subcutaneous injection
Label Dose Somatropin	Somatropin: 0.025 to 0.035 milligram/kilogram/day subcutaneous injection

Participant Flow: Overall Study

	High Dose Somatropin	Label Dose Somatropin
STARTED	14	13
COMPLETED	12	11
NOT COMPLETED	2	2
Adverse Event	2	0
Protocol Violation	0	1
Participant Moved Away	0	1

Baseline Characteristics

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Reporting Groups

	Description
High Dose Somatropin	Somatropin: 0.05 to 0.07 milligram/kilogram/day subcutaneous injection
Label Dose Somatropin	Somatropin: 0.025 to 0.035 milligram/kilogram/day subcutaneous injection

Baseline Measures

	High Dose Somatropin	Label Dose Somatropin	Total
Number of Participants [units: participants]	14	13	27
Age [units: years] Mean ± Standard Deviation	13.5 ± 1.2	13.0 ± 1.5	13.3 ± 1.3
Gender [units: participants]
Female	1	3	4
Male	13	10	23
Region of Enrollment [units: participants]
Italy	14	13	27
Race/Ethnicity [units: participants]
Caucasian	14	12	26
Other	0	1	1
Baseline Predicted Height ^[1] [units: centimeters] Mean ± Standard Deviation	168 ± 6.8	169 ± 10.7	168 ± 8.7
Baseline Predicted Height Standard Deviation Score (SDS) ^[2] [units: standard deviation score] Mean ± Standard Deviation	-0.9 ± 0.8	-0.5 ± 1.0	-0.7 ± 0.9
Body Mass Index ^[3] [units: kilograms per square meter (kg/m2)] Mean ± Standard Deviation	18.9 ± 3.2	19.4 ± 3.7	19.2 ± 3.4
Bone Age ^[4] [units: years] Mean ± Standard Deviation	12.4 ± 0.7	12.1 ± 1.0	12.2 ± 0.8
Height ^[5] [units: centimeters] Mean ± Standard Deviation	145 ± 5.1	146 ± 7.8	145 ± 6.5
Height Standard Deviation Score (SDS) ^[6] [units: standard deviation score] Mean ± Standard Deviation	-1.7 ± 1.0	-1.1 ± 1.0	-1.4 ± 1.0
Target Height ^[7] [units: centimeters] Mean ± Standard Deviation	168 ± 5.0	168 ± 7.5	168 ± 6.2
Target Height Standard Deviation Score (SDS) ^[8] [units: standard deviation score] Mean ± Standard Deviation	-0.9 ± 0.7	-0.6 ± 0.5	-0.8 ± 0.6

[1]	Bone age, chronological age, gender, and height at Visit 0 were used to calculate the Baseline Predicted Height (BLPH) using the method of Bayley and Pinneau. Bone age for the BLPH was based on the Greulich-Pyle bone age assessment of the Visit 0 bone age x-ray.
[2]	BLPH expressed as a height SDS value (height SDS was derived by subtracting the age-and-gender-matched population 50th percentile height from the patient’s height and then dividing this value by the age-and-gender-matched population height standard deviation) using the British standards at age 18 for boys and 16 for girls.
[3]	Body mass index is an estimate of body fat based on body weight divided by height squared.
[4]	Bone age was determined by the Greulich-Pyle method.
[5]	Standing measurements were to be made using a standard wall-mounted stadiometer.
[6]	Height SDS was derived by subtracting the age-and-gender-matched population 50th percentile height from the patient’s height and then dividing this value by the age-and-gender-matched population height standard deviation (SD).
[7]	Target Height represents the approximate adult height that the patient could be expected to attain, based on the heights of her/his parents. This is a gender-adjusted, average height of the patient’s parents’ heights calculated in centimeters, modified from the method of Tanner et al.
[8]	Target height expressed as height SDS value (see height SDS description for how height SDS value was derived) based on patient’s gender, compared to British reference population at age 18 years for males and 16 years for females.

Outcome Measures

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1. Primary:

Height Velocity Standard Deviation Score (SDS) at 12-Month Endpoint [ Time Frame: 12-Months ]

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2. Secondary:

Change From Baseline to 12-Month and 24-Month Endpoints in Height Standard Deviation Score (SDS) [ Time Frame: Baseline, 12-Months, 24-Months ]

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3. Secondary:

Height Velocity Standard Deviation Score (SDS) at 24 Month Endpoint [ Time Frame: 24 Months ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
phone: 800-545-5979

No publications provided

Responsible Party:	Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier:	NCT00191165 History of Changes
Other Study ID Numbers:	5202, B9R-IT-GDFU
Study First Received:	September 12, 2005
Results First Received:	April 7, 2009
Last Updated:	June 8, 2009
Health Authority:	Italy: Ministry of Health