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Anterior Pituitary Hormone Replacement in Traumatic Brain Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00957671
Recruitment Status : Completed
First Posted : August 12, 2009
Results First Posted : May 15, 2018
Last Update Posted : June 29, 2018
Sponsor:
Collaborator:
The Moody Foundation
Information provided by (Responsible Party):
The University of Texas Medical Branch, Galveston

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Growth Hormone Deficiency
Traumatic Brain Injury
Intervention Drug: Recombinant human growth hormone
Enrollment 15
Recruitment Details Subjects with a history of mild to severe traumatic brain injury were recruited from 2010 to 2014. Subjects were screened for abnormal growth hormone secretion by glucagon stimulation test. 19 subjects were screened for this study. 15 of the subjects met final inclusion/exclusion criteria and began the treatment phase.
Pre-assignment Details  
Arm/Group Title Human Growth Hormone
Hide Arm/Group Description

recombinant human growth hormone (rhGH) self administered daily for one year.

Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total).

Period Title: Overall Study
Started 15 [1]
Completed 15 [2]
Not Completed 0
[1]
15 subjects began the treatment phase.
[2]
15 subjects completed the treatment phase of the study.
Arm/Group Title Human Growth Hormone
Hide Arm/Group Description

Recombinant human growth hormone (rhGH) self administered daily for one year

Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total)

Overall Number of Baseline Participants 15
Hide Baseline Analysis Population Description
15 subjects with a history of mild to severe traumatic brain injury and abnormal growth hormone secretion were enrolled in this trial.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
<=18 years
0
   0.0%
Between 18 and 65 years
15
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants
45.5  (11.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Female
5
  33.3%
Male
10
  66.7%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 15 participants
15
 100.0%
Age at time of injury  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants
34.3  (15.7)
1.Primary Outcome
Title Maximum Oxygen Uptake at Baseline.
Hide Description Maximum Oxygen Uptake was measured during cardiorespiratory testing using a modified Balke protocol with expired gases collected and analyzed by an automated metabolic cart.
Time Frame baseline
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[Not Specified]
Arm/Group Title Human Growth Hormone
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recombinant human growth hormone (rhGH) self administered daily for one year.

Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total).

Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: mL/kg/min
29.0  (7.2)
2.Primary Outcome
Title Maximum Oxygen Uptake After One Year of Human Growth Hormone Replacement Therapy.
Hide Description Maximum Oxygen Uptake was measured during cardiorespiratory testing using a modified Balke protocol with expired gases collected and analyzed by an automated metabolic cart.
Time Frame one year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Human Growth Hormone
Hide Arm/Group Description:

recombinant human growth hormone (rhGH) self administered daily for one year.

Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total).

Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: mL/kg/min
32.1  (7.4)
3.Primary Outcome
Title Minute Ventilation at Baseline.
Hide Description Minute ventilation was measured during cardiorespiratory testing using a modified Balke protocol with expired gases collected and analyzed by an automated metabolic cart.
Time Frame baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Human Growth Hormone
Hide Arm/Group Description:

recombinant human growth hormone (rhGH) self administered daily for one year.

Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total).

Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: L/minute
90.4  (24.2)
4.Primary Outcome
Title Minute Ventilation After One Year of Human Growth Hormone Replacement Therapy.
Hide Description Minute ventilation was measured during cardiorespiratory testing using a modified Balke protocol with expired gases collected and analyzed by an automated metabolic cart.
Time Frame one year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Human Growth Hormone
Hide Arm/Group Description:

recombinant human growth hormone (rhGH) self administered daily for one year.

Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total).

Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: L/minute
102.4  (23.1)
5.Primary Outcome
Title Respiratory Exchange Ratio at Baseline.
Hide Description Respiratory exchange ratio was measured during cardiorespiratory testing using a modified Balke protocol with expired gases collected and analyzed by an automated metabolic cart.
Time Frame baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Human Growth Hormone
Hide Arm/Group Description:

recombinant human growth hormone (rhGH) self administered daily for one year.

Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total).

Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: ratio of CO2/O2
1.27  (0.12)
6.Primary Outcome
Title Respiratory Exchange Ratio After One Year of Human Growth Hormone Replacement Therapy.
Hide Description Respiratory exchange ratio was measured during cardiorespiratory testing using a modified Balke protocol with expired gases collected and analyzed by an automated metabolic cart.
Time Frame one year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Human Growth Hormone
Hide Arm/Group Description:

recombinant human growth hormone (rhGH) self administered daily for one year.

Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total).

Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: ratio of CO2/O2
1.27  (0.10)
7.Primary Outcome
Title Oxygen Pulse at Baseline.
Hide Description Oxygen Pulse was measured during cardiorespiratory testing using a modified Balke protocol with expired gases collected and analyzed by an automated metabolic cart. Oxygen pulse is calculated by dividing VO2 consumed (mL/min) by heart rate (beats/min) yielding mL/beat. This provides an estimate of cardiac stroke volume.
Time Frame baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Human Growth Hormone
Hide Arm/Group Description:

recombinant human growth hormone (rhGH) self administered daily for one year.

Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total).

Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: mL/beat
15.2  (4.1)
8.Primary Outcome
Title Oxygen Pulse After One Year of Human Growth Hormone Replacement Therapy.
Hide Description Oxygen Pulse was measured during cardiorespiratory testing using a modified Balke protocol with expired gases collected and analyzed by an automated metabolic cart. Oxygen pulse is calculated by dividing VO2 consumed (mL/min) by heart rate (beats/min) yielding mL/beat. This provides an estimate of cardiac stroke volume.
Time Frame one year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Human Growth Hormone
Hide Arm/Group Description:

recombinant human growth hormone (rhGH) self administered daily for one year.

Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total).

Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: mL/beat
16.4  (4.2)
9.Secondary Outcome
Title Neuropsychological Function as Measured by California Verbal Learning Test-II With Total Recall at Baseline.
Hide Description The California Verbal Learning Test II (CVLT-II) is a comprehensive assessment of verbal learning and memory. Subjects are read a list of 16 words. Total recall is a sum of all word list items correctly recalled immediately on learning trials 1 through 5. Data is reported as raw scores. Score range is 0 (lowest) to 80 (highest). A higher score indicates a better outcome.
Time Frame baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Human Growth Hormone
Hide Arm/Group Description:

recombinant human growth hormone (rhGH) self administered daily for one year

Recombinant human growth hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total)

Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: scores on a scale
45.7  (10.8)
10.Secondary Outcome
Title Neuropsychological Function as Measured by California Verbal Learning Test-II With Total Recall After 1 Year of Human Growth Hormone Replacement Therapy.
Hide Description The California Verbal Learning Test II (CVLT-II) is a comprehensive assessment of verbal learning and memory. Subjects are read a list of 16 words. Total recall is a sum of all word list items correctly recalled immediately on learning trials 1 through 5. Data is reported as raw scores. Score range is 0 (lowest) to 80 (highest). A higher score indicates a better outcome.
Time Frame One year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Human Growth Hormone
Hide Arm/Group Description:

recombinant human growth hormone (rhGH) self administered daily for one year.

Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total).

Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: scores on a scale
51.0  (9.4)
11.Secondary Outcome
Title Neuropsychological Function as Measured by California Verbal Learning Test-II With Delayed Recall at Baseline.
Hide Description The California Verbal Learning Test II (CVLT-II) is a comprehensive assessment of verbal learning and memory. Subjects are read a list of 16 words. Delayed recall is a sum of all word list items correctly recalled after a 25 minute delay on learning trials 1 through 5. Data is reported as raw scores. Score range is 0 (lowest) to 80 (highest). A higher score indicates a better outcome.
Time Frame baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Human Growth Hormone
Hide Arm/Group Description:

recombinant human growth hormone (rhGH) self administered daily for one year.

Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total).

Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: scores on a scale
9.9  (3.8)
12.Secondary Outcome
Title Neuropsychological Function as Measured by California Verbal Learning Test-II With Delayed Recall After 1 Year of Human Growth Hormone Replacement Therapy.
Hide Description The California Verbal Learning Test II (CVLT-II) is a comprehensive assessment of verbal learning and memory. Subjects are read a list of 16 words. Delayed recall is a sum of all word list items correctly recalled after a 25 minute delay on learning trials 1 through 5. Data is reported as raw scores. Score range is 0 (lowest) to 80 (highest). A higher score indicates a better outcome.
Time Frame One year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Human Growth Hormone
Hide Arm/Group Description:

recombinant human growth hormone (rhGH) self administered daily for one year.

Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total).

Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: scores on a scale
11.2  (2.6)
13.Secondary Outcome
Title Neuropsychological Function as Measured by Brief Visuospatial Memory Test-R With Total Recall at Baseline
Hide Description The Brief Visuospatial Memory Test is measure of visual memory. The subject views a stimulus page with 6 shapes on it for 10 seconds. The subjects are then asked to draw as many figures as they remember in the correct locations as possible. Total recall is a measure of the subjects memory immediately after viewing the stimulus page. Data is reported as raw scores. Scores range from 0 (lowest) to 36 (highest). A higher score indicates a better outcome.
Time Frame baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Human Growth Hormone
Hide Arm/Group Description:

recombinant human growth hormone (rhGH) self administered daily for one year.

Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total).

Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: scores on a scale
18.7  (5.7)
14.Secondary Outcome
Title Neuropsychological Function as Measured by Brief Visuospatial Memory Test-R With Total Recall After 1 Year of Human Growth Hormone Replacement Therapy.
Hide Description The Brief Visuospatial Memory Test is measure of visual memory. The subject views a stimulus page with 6 shapes on it for 10 seconds. The subjects are then asked to draw as many figures as they remember in the correct locations as possible. Total recall is a measure of the subjects memory immediately after viewing the stimulus page. Data is reported as raw scores. Scores range from 0 (lowest) to 36 (highest). A higher score indicates a better outcome.
Time Frame one year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Human Growth Hormone
Hide Arm/Group Description:

recombinant human growth hormone (rhGH) self administered daily for one year.

Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total).

Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: scores on a scale
22.7  (5.1)
15.Secondary Outcome
Title Neuropsychological Function as Measured by Brief Visuospatial Memory Test-R With Delayed Recall at Baseline
Hide Description The Brief Visuospatial Memory Test is measure of visual memory. The subject views a stimulus page with 6 shapes on it for 10 seconds. The subjects are then asked to draw as many figures as they remember in the correct locations as possible. The delayed recall is a measure of the subjects memory after a 25 minutes delay. The participants are asked to freely recall and again draw the six figures.Data is reported as raw scores. Scores range from 0 (lowest) to 36 (highest). A higher score indicates a better outcome.
Time Frame baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Human Growth Hormone
Hide Arm/Group Description:

recombinant human growth hormone (rhGH) self administered daily for one year.

Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total).

Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: scores on a scale
7.2  (2.9)
16.Secondary Outcome
Title Neuropsychological Function as Measured by Brief Visuospatial Memory Test-R With Delayed Recall After 1 Year of Human Growth Hormone Replacement Therapy
Hide Description The Brief Visuospatial Memory Test is measure of visual memory. The subject views a stimulus page with 6 shapes on it for 10 seconds. The subjects are then asked to draw as many figures as they remember in the correct locations as possible. The delayed recall is a measure of the subjects memory after a 25 minutes delay. The participants are asked to freely recall and again draw the six figures.Data is reported as raw scores. Scores range from 0 (lowest) to 36 (highest). A higher score indicates a better outcome.
Time Frame one year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Human Growth Hormone
Hide Arm/Group Description:

recombinant human growth hormone (rhGH) self administered daily for one year.

Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total).

Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: scores on a scale
9.1  (2.2)
17.Secondary Outcome
Title Neuropsychological Function as Measured by Digit Span Total at Baseline
Hide Description

Digit Span; Wechsler Memory Scale III (WMS III).

Digits Forward is a test of digit span (range = 3 to 9 digits) consisting of seven items (each with 2 trials). Digits Backward is a test of digit span (range = 3 to 9 digits); however the participant must provide the presented sequence in reverse order. The test consists of seven items (each with 2 trials). Total score is calculated by adding the scores from forward and backward. Data is reported as raw scores. Score ranges are 0 (lowest) to 32 (highest). A higher score indicates a better outcome.

Time Frame baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Human Growth Hormone
Hide Arm/Group Description:

recombinant human growth hormone (rhGH) self administered daily for one year.

Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total).

Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: scores on a scale
16.0  (4.5)
18.Secondary Outcome
Title Neuropsychological Function as Measured by Digit Span Total After One Year of Human Growth Hormone Replacement Therapy.
Hide Description Digit Span; Wechsler Memory Scale III (WMS III). Digits Forward is a test of digit span (range = 3 to 9 digits) consisting of seven items (each with 2 trials). Digits Backward is a test of digit span (range = 3 to 9 digits); however the participant must provide the presented sequence in reverse order. The test consists of seven items (each with 2 trials). Total score is calculated by adding the scores from forward and backward. Data is reported as raw scores. Score ranges are 0 (lowest) to 32 (highest). A higher score indicates a better outcome.
Time Frame one year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Human Growth Hormone
Hide Arm/Group Description:

recombinant human growth hormone (rhGH) self administered daily for one year.

Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total).

Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: scores on a scale
17.0  (3.9)
19.Secondary Outcome
Title Neuropsychological Function as Measured by Processing Speed Index at Baseline
Hide Description

Processing Speed Index is a subcategory of the Wechsler Adult Intelligence Scale III (WAIS-III). Processing speed refers to the speed of cognitive processes and response output.

This index is comprised of performances on two separate tests of visuomotor speed of information processing ability. On one test (Coding) participants refer to a key on top of a page to translate non-verbal symbols to an alpha-numeric digit. The participants then fill in boxes with the correct symbol assigned to a particular number. On the other test (Symbol Search) participants are asked to visually scan and mark items that are identical to one of two targets. If neither target is shown in the array the participant must mark out the work "NO". Total correct responses for both task within 120 seconds are recorded.

Ranges are 0 (lowest) to 150 (highest) with 100 being the normal average. A higher score indicates a better outcome.

Time Frame baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Human Growth Hormone
Hide Arm/Group Description:

recombinant human growth hormone (rhGH) self administered daily for one year.

Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total).

Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: scores on a scale
102.3  (14.9)
20.Secondary Outcome
Title Neuropsychological Function as Measured by Processing Speed Index After One Year of Human Growth Hormone Replacement Therapy.
Hide Description

Processing Speed Index is a subcategory of the Wechsler Adult Intelligence Scale III (WAIS-III). Processing speed refers to the speed of cognitive processes and response output.

This index is comprised of performances on two separate tests of visuomotor speed of information processing ability. On one test (Coding) participants refer to a key on top of a page to translate non-verbal symbols to an alpha-numeric digit. The participants then fill in boxes with the correct symbol assigned to a particular number. On the other test (Symbol Search) participants are asked to visually scan and mark items that are identical to one of two targets. If neither target is shown in the array the participant must mark out the work "NO". Total correct responses for both task within 120 seconds are recorded.

Ranges are 0 (lowest) to 150 (highest) with 100 being the normal average. A higher score indicates a better outcome.

Time Frame one year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Human Growth Hormone
Hide Arm/Group Description:

recombinant human growth hormone (rhGH) self administered daily for one year.

Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total).

Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: scores on a scale
106.6  (15.0)
21.Secondary Outcome
Title Neuropsychological Function as Measured by Letter Fluency at Baseline
Hide Description Letter Fluency is a condition measured as part of the subcategory, Verbal Fluency, in the Delis-Kaplan Executive Function System (D-KEFS). Subjects are asked to name as many words as they can starting with a specified letter for 60 seconds. The words can not be names, places, numbers or grammatical variants of previous answers. Repeated answers are not scored as a correct response. There are 3 trials, with 3 different letters. The total number of correct responses is totaled for all 3 trials and a Letter Fluency Score is given. A higher score is considered better. There is no set range as the score depends on how many correct words the subject relays in the given time period.
Time Frame baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Human Growth Hormone
Hide Arm/Group Description:

recombinant human growth hormone (rhGH) self administered daily for one year.

Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total).

Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: scores on a scale
38.5  (14.5)
22.Secondary Outcome
Title Neuropsychological Function as Measured by Letter Fluency After One Year of Human Growth Hormone Replacement Therapy
Hide Description Letter Fluency is a condition measured as part of the subcategory, Verbal Fluency, in the Delis-Kaplan Executive Function System (D-KEFS). Subjects are asked to name as many words as they can starting with a specified letter for 60 seconds. The words can not be names, places, numbers or grammatical variants of previous answers. Repeated answers are not scored as a correct response. There are 3 trials, with 3 different letters. The total number of correct responses is totaled for all 3 trials and a Letter Fluency Score is given. A higher score is considered better. There is no set range as the score depends on how many correct words the subject relays in the given time period.
Time Frame one year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Human Growth Hormone
Hide Arm/Group Description:

recombinant human growth hormone (rhGH) self administered daily for one year.

Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total).

Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: scores on a scale
35.4  (13.0)
23.Secondary Outcome
Title Depression as Measured by the Beck Depression Inventory at Baseline.
Hide Description Beck Depression Inventory (BDI-II) is used to measure the severity of depression symptoms. The BDI-II contains 21 questions, each answer being scored on a scale value of 0 to 3. Higher total scores indicate more severe depressive symptoms. The standardized cutoffs are: 0–13: minimal depression; 14–19: mild; depression; 20–28: moderate depression; 29–63: severe depression.
Time Frame baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Human Growth Hormone
Hide Arm/Group Description:

recombinant human growth hormone (rhGH) self administered daily for one year.

Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total).

Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: scores on a scale
13.8  (9.7)
24.Secondary Outcome
Title Depression as Measured by Beck Depression Inventory After One Year of Human Growth Hormone Replacement Therapy.
Hide Description Beck Depression Inventory (BDI-II) is used to measure the severity of depression symptoms. The BDI-II contains 21 questions, each answer being scored on a scale value of 0 to 3. Higher total scores indicate more severe depressive symptoms. The standardized cutoffs are: 0-13: minimal depression; 14-19: mild; depression; 20-28: moderate depression; 29-63: severe depression.
Time Frame one year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Human Growth Hormone
Hide Arm/Group Description:

recombinant human growth hormone (rhGH) self administered daily for one year.

Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total).

Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: scores on a scale
6.2  (6.9)
25.Secondary Outcome
Title Fatigue as Measured Using Fatigue Severity Scale at Baseline.
Hide Description Fatigue Severity Scale (FSS) is a measure of fatigue and how that fatigue interferes with life. It is a 9-item scale, with a range from 9 to 63, with a higher number indicating greater severity.
Time Frame baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Human Growth Hormone
Hide Arm/Group Description:

recombinant human growth hormone (rhGH) self administered daily for one year.

Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total).

Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: scores on a scale
44.3  (13.5)
26.Secondary Outcome
Title Fatigue Measured Using the Fatigue Severity Scale After One Year of Human Growth Hormone Therapy.
Hide Description Fatigue Severity Scale (FSS) is a measure of fatigue and how that fatigue interferes with life. It is a 9-item scale, with a range from 9 to 63, with a higher number indicating greater severity.
Time Frame one year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Human Growth Hormone
Hide Arm/Group Description:

recombinant human growth hormone (rhGH) self administered daily for one year.

Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total).

Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: scores on a scale
34.0  (12.5)
27.Secondary Outcome
Title Muscle Function in Male Subjects Measured Using Maximum Isometric Leg Extension by Biodex Pro 4 at Baseline.
Hide Description Maximum torque production during isometric contraction of the knee extensor muscles.
Time Frame baseline
Hide Outcome Measure Data
Hide Analysis Population Description
This is the data for the 10 male subjects enrolled in this study.
Arm/Group Title Human Growth Hormone
Hide Arm/Group Description:

recombinant human growth hormone (rhGH) self administered daily for one year.

Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total).

Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: Newton-Meters
206.0  (32.41)
28.Secondary Outcome
Title Muscle Function in Male Subjects Measured Using Maximum Isometric Leg Extension by Biodex Pro 4 After One Year of Human Growth Hormone Replacement Therapy.
Hide Description Maximum torque production during isometric contraction of the knee extensor muscles.
Time Frame one year
Hide Outcome Measure Data
Hide Analysis Population Description
This is the data for the 10 male subjects in this study.
Arm/Group Title Human Growth Hormone
Hide Arm/Group Description:

recombinant human growth hormone (rhGH) self administered daily for one year.

Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total).

Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: Newton-Meters
209.6  (37.65)
29.Secondary Outcome
Title Muscle Function in Male Subjects Measured Using Maximum Isokinetic Leg Extension by Biodex Pro 4 at Baseline.
Hide Description Maximum torque production during maximal isokinetic contractions at 90 degrees per second.
Time Frame baseline
Hide Outcome Measure Data
Hide Analysis Population Description
This data is for the 10 male subjects enrolled in this study.
Arm/Group Title Human Growth Hormone
Hide Arm/Group Description:

recombinant human growth hormone (rhGH) self administered daily for one year.

Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total).

Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: Newton-Meters
175.2  (36.61)
30.Secondary Outcome
Title Muscle Function in Male Subjects Measured Using Maximum Isokinetic Leg Extension by Biodex Pro 4 After One Year of Human Growth Hormone Replacement Therapy.
Hide Description Maximum torque production during maximal isokinetic contractions at 90 degrees per second.
Time Frame one year
Hide Outcome Measure Data
Hide Analysis Population Description
This data is for the 10 male subjects in this study.
Arm/Group Title Human Growth Hormone
Hide Arm/Group Description:

recombinant human growth hormone (rhGH) self administered daily for one year.

Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total).

Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: Newton-Meters
182.6  (45.29)
31.Secondary Outcome
Title Muscle Fatigue as Measured by Biodex Pro 4 at Baseline.
Hide Description Muscle fatigue is measured using repetitive isokinetic contractions of the knee extensors at 90 degrees per second. Each subject was asked to produce 40 contractions at full force. Data is presented as % of maximum torque at the 40th contraction in the fatigue protocol.
Time Frame baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Human Growth Hormone
Hide Arm/Group Description:

recombinant human growth hormone (rhGH) self administered daily for one year.

Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total).

Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: Percent of Maximum Torque
35.1  (6.30)
32.Secondary Outcome
Title Muscle Fatigue as Measured by Biodex Pro 4 After One Year of Human Growth Hormone Replacement Therapy.
Hide Description Muscle fatigue is measured using repetitive isokinetic contractions of the knee extensors at 90 degrees per second. Each subject was asked to produce 40 contractions at full force. Data is presented as % of maximum torque at the 40th contraction in the fatigue protocol.
Time Frame one year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Human Growth Hormone
Hide Arm/Group Description:

recombinant human growth hormone (rhGH) self administered daily for one year.

Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total).

Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: Percent of Maximum Torque
36.9  (9.89)
33.Secondary Outcome
Title Body Mass in Male Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) at Baseline.
Hide Description Body mass was calculated from whole body scan taken using a GE Lunar iDEXA.
Time Frame baseline
Hide Outcome Measure Data
Hide Analysis Population Description
This data is for the 10 male subjects in the study.
Arm/Group Title Human Growth Hormone
Hide Arm/Group Description:

recombinant human growth hormone (rhGH) self administered daily for one year.

Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total).

Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: kilograms
96.04  (18.38)
34.Secondary Outcome
Title Body Mass in Male Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) After One Year of Human Growth Hormone Replacement Therapy.
Hide Description Body mass was calculated from whole body scan taken using a GE Lunar iDEXA
Time Frame one year
Hide Outcome Measure Data
Hide Analysis Population Description
This is the data for the 10 male subjects in the study.
Arm/Group Title Human Growth Hormone
Hide Arm/Group Description:

recombinant human growth hormone (rhGH) self administered daily for one year.

Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total).

Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: kilograms
96.55  (19.67)
35.Secondary Outcome
Title Lean Body Mass in Male Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) at Baseline
Hide Description Lean Body mass was calculated from whole body scan taken using a GE Lunar iDEXA
Time Frame baseline
Hide Outcome Measure Data
Hide Analysis Population Description
This data is for the 10 male subjects enrolled in this study.
Arm/Group Title Human Growth Hormone
Hide Arm/Group Description:

recombinant human growth hormone (rhGH) self administered daily for one year.

Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total).

Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: kilograms
61.68  (7.55)
36.Secondary Outcome
Title Lean Body Mass in Male Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) After One Year of Human Growth Hormone Replacement Therapy.
Hide Description Lean Body mass was calculated from whole body scan taken using a GE Lunar iDEXA
Time Frame one year
Hide Outcome Measure Data
Hide Analysis Population Description
This data is for the 10 male subjects enrolled in the study.
Arm/Group Title Human Growth Hormone
Hide Arm/Group Description:

recombinant human growth hormone (rhGH) self administered daily for one year.

Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total).

Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: kilograms
63.70  (8.14)
37.Secondary Outcome
Title Fat Free Mass in Male Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) at Baseline.
Hide Description Fat free mass is calculated from whole body scan measured using a GE Lunar iDEXA.
Time Frame baseline
Hide Outcome Measure Data
Hide Analysis Population Description
This data is for the 10 male subjects enrolled in this study.
Arm/Group Title Human Growth Hormone
Hide Arm/Group Description:

recombinant human growth hormone (rhGH) self administered daily for one year.

Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total).

Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: kilograms
31.19  (13.75)
38.Secondary Outcome
Title Fat Free Mass in Male Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) After One Year of Human Growth Hormone Replacement Therapy.
Hide Description Fat free mass is calculated from whole body scan measured on a GE Lunar iDEXA.
Time Frame one year
Hide Outcome Measure Data
Hide Analysis Population Description
This is the data for the 10 male subjects enrolled in the study.
Arm/Group Title Human Growth Hormone
Hide Arm/Group Description:

recombinant human growth hormone (rhGH) self administered daily for one year.

Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total).

Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: kilogram
29.67  (14.30)
39.Secondary Outcome
Title Percent Body Fat as Measured by Dual Energy X-Ray Absorptiometry (DEXA) at Baseline.
Hide Description Percent body fat is calculated from a whole body scan measured on a GE Lunar iDEXA.
Time Frame baseline
Hide Outcome Measure Data
Hide Analysis Population Description
This data is for the 10 male subjects enrolled in this study.
Arm/Group Title Human Growth Hormone
Hide Arm/Group Description:

recombinant human growth hormone (rhGH) self administered daily for one year.

Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total).

Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: percent of body fat
32.47  (8.47)
40.Secondary Outcome
Title Percent Body Fat in Male Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) After One Year of Human Growth Hormone Replacement Therapy.
Hide Description Percent body fat is calculated from a whole body scan measured on a GE Lunar iDEXA.
Time Frame one year
Hide Outcome Measure Data
Hide Analysis Population Description
This data is for the 10 male subjects in the study.
Arm/Group Title Human Growth Hormone
Hide Arm/Group Description:

recombinant human growth hormone (rhGH) self administered daily for one year.

Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total).

Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: percent of body fat
30.5  (9.40)
41.Secondary Outcome
Title Muscle Function in Female Subjects Measured Using Maximum Isometric Leg Extension by Biodex Pro 4 at Baseline.
Hide Description Maximum torque production during isometric contraction of the knee extensor muscles.
Time Frame baseline
Hide Outcome Measure Data
Hide Analysis Population Description
This data is for the 5 female subjects enrolled in this study.
Arm/Group Title Human Growth Hormone
Hide Arm/Group Description:

recombinant human growth hormone (rhGH) self administered daily for one year.

Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total).

Overall Number of Participants Analyzed 5
Mean (Standard Deviation)
Unit of Measure: Newton-Meters
131.5  (26.38)
42.Secondary Outcome
Title Muscle Function in Female Subjects Measured Using Maximum Isometric Leg Extension by Biodex Pro 4 After One Year of Human Growth Hormone Replacement Therapy
Hide Description Maximum torque production during isometric contraction of the knee extensor muscles.
Time Frame one year
Hide Outcome Measure Data
Hide Analysis Population Description
This data is for the 5 female subjects in the study.
Arm/Group Title Human Growth Hormone
Hide Arm/Group Description:

recombinant human growth hormone (rhGH) self administered daily for one year.

Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total).

Overall Number of Participants Analyzed 5
Mean (Standard Deviation)
Unit of Measure: Newton-Meters
130.7  (34.77)
43.Secondary Outcome
Title Muscle Function in Female Subjects Measured Using Maximum Isokinetic Leg Extension by Biodex Pro 4 at Baseline
Hide Description Maximum torque production during maximal isokinetic contractions at 90 degrees per second.
Time Frame baseline
Hide Outcome Measure Data
Hide Analysis Population Description
This data is for the 5 female subjects enrolled in this study.
Arm/Group Title Human Growth Hormone
Hide Arm/Group Description:

recombinant human growth hormone (rhGH) self administered daily for one year.

Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total).

Overall Number of Participants Analyzed 5
Mean (Standard Deviation)
Unit of Measure: Newton-Meters
103.9  (12.56)
44.Secondary Outcome
Title Muscle Function in Female Subjects Measured Using Maximum Isokinetic Leg Extension by Biodex Pro 4 After One Year of Human Growth Hormone Replacement Therapy
Hide Description Maximum torque production during maximal isokinetic contractions at 90 degrees per second.
Time Frame one year
Hide Outcome Measure Data
Hide Analysis Population Description
This data is for the 5 female subjects enrolled in this study.
Arm/Group Title Human Growth Hormone
Hide Arm/Group Description:

recombinant human growth hormone (rhGH) self administered daily for one year.

Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total).

Overall Number of Participants Analyzed 5
Mean (Standard Deviation)
Unit of Measure: Newton-Meters
99.6  (17.58)
45.Secondary Outcome
Title Perceptual Fatigability as Measured by a Fatigue Rating Scale at Baseline.
Hide Description Perceptual fatigue was measured before and directly after performing the muscle fatigue exercise protocol (40 continuous maximal force isokinetic knee extensions at 90 degress per second). Subjects were asked to rate their fatigue on a scale of 0-10 with 0 being no fatigue at all and 10 being extreme fatigue. Data is presented as change in fatigue rating induced by exercise testing.
Time Frame baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Human Growth Hormone
Hide Arm/Group Description:

recombinant human growth hormone (rhGH) self administered daily for one year.

Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total).

Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.78  (1.75)
46.Secondary Outcome
Title Perceptual Fatigability as Measured by a Fatigue Rating Scale After One Year of Human Growth Hormone Therapy.
Hide Description Perceptual fatigue was measured before and directly after performing the muscle fatigue exercise protocol (40 continuous maximal force isokinetic knee extensions at 90 degress per second). Subjects were asked to rate their fatigue on a scale of 0-10 with 0 being no fatigue at all and 10 being extreme fatigue. Data is presented as change in fatigue rating induced by exercise testing.
Time Frame one year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Human Growth Hormone
Hide Arm/Group Description:

recombinant human growth hormone (rhGH) self administered daily for one year.

Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total).

Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.17  (1.54)
47.Secondary Outcome
Title Body Mass in Female Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) at Baseline.
Hide Description [Not Specified]
Time Frame baseline
Hide Outcome Measure Data
Hide Analysis Population Description
This is the data for the 5 females in the study.
Arm/Group Title Human Growth Hormone
Hide Arm/Group Description:

recombinant human growth hormone (rhGH) self administered daily for one year.

Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total).

Overall Number of Participants Analyzed 5
Mean (Standard Deviation)
Unit of Measure: kilograms
75.64  (10.80)
48.Secondary Outcome
Title Body Mass in Female Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) After One Year of Human Growth Hormone Replacement Therapy
Hide Description Body mass was calculated from whole body scan taken using a GE Lunar iDEXA
Time Frame one year
Hide Outcome Measure Data
Hide Analysis Population Description
This data represents the 5 females in the study.
Arm/Group Title Human Growth Hormone
Hide Arm/Group Description:

recombinant human growth hormone (rhGH) self administered daily for one year.

Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total).

Overall Number of Participants Analyzed 5
Mean (Standard Deviation)
Unit of Measure: kilograms
76.54  (10.57)
49.Secondary Outcome
Title Lean Body Mass in Female Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) at Baseline
Hide Description Lean Body mass was calculated from whole body scan taken using a GE Lunar iDEXA.
Time Frame baseline
Hide Outcome Measure Data
Hide Analysis Population Description
This data is for the 5 female subjects in the study.
Arm/Group Title Human Growth Hormone
Hide Arm/Group Description:

recombinant human growth hormone (rhGH) self administered daily for one year.

Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total).

Overall Number of Participants Analyzed 5
Mean (Standard Deviation)
Unit of Measure: kilograms
43.84  (1.42)
50.Secondary Outcome
Title Lean Body Mass in Female Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) After One Year of Human Growth Hormone Replacement Therapy.
Hide Description Lean Body mass was calculated from whole body scan taken using a GE Lunar iDEXA
Time Frame one year
Hide Outcome Measure Data
Hide Analysis Population Description
This data is for the 5 female subjects in the study.
Arm/Group Title Human Growth Hormone
Hide Arm/Group Description:

recombinant human growth hormone (rhGH) self administered daily for one year.

Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total).

Overall Number of Participants Analyzed 5
Mean (Standard Deviation)
Unit of Measure: kilograms
44.92  (3.47)
51.Secondary Outcome
Title Fat Free Mass in Female Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) at Baseline.
Hide Description Fat free mass is calculated from whole body scan measured using a GE Lunar iDEXA.
Time Frame baseline
Hide Outcome Measure Data
Hide Analysis Population Description
This data is for the 5 female subjects in the study.
Arm/Group Title Human Growth Hormone
Hide Arm/Group Description:

recombinant human growth hormone (rhGH) self administered daily for one year.

Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total).

Overall Number of Participants Analyzed 5
Mean (Standard Deviation)
Unit of Measure: kilograms
29.31  (9.86)
52.Secondary Outcome
Title Fat Free Mass in Female Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) After One Year of Human Growth Hormone Replacement Therapy
Hide Description Fat free mass is calculated from whole body scan measured on a GE Lunar iDEXA.
Time Frame one year
Hide Outcome Measure Data
Hide Analysis Population Description
This is the data for the 5 female subjects.
Arm/Group Title Human Growth Hormone
Hide Arm/Group Description:

recombinant human growth hormone (rhGH) self administered daily for one year.

Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total).

Overall Number of Participants Analyzed 5
Mean (Standard Deviation)
Unit of Measure: kilograms
29.15  (8.74)
53.Secondary Outcome
Title Percent Body Fat in Female Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) at Baseline.
Hide Description Percent body fat is calculated from a whole body scan measured on a GE Lunar iDEXA.
Time Frame baseline
Hide Outcome Measure Data
Hide Analysis Population Description
This data is for the 5 female subjects enrolled in the study.
Arm/Group Title Human Growth Hormone
Hide Arm/Group Description:

recombinant human growth hormone (rhGH) self administered daily for one year.

Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total).

Overall Number of Participants Analyzed 5
Mean (Standard Deviation)
Unit of Measure: percent of body fat
38.92  (8.17)
54.Secondary Outcome
Title Percent Body Fat in Female Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) After One Year of Human Growth Hormone Replacement Therapy.
Hide Description Percent body fat is calculated from a whole body scan measured on a GE Lunar iDEXA.
Time Frame one year
Hide Outcome Measure Data
Hide Analysis Population Description
This data is for the 5 female subjects enrolled in this study.
Arm/Group Title Human Growth Hormone
Hide Arm/Group Description:

recombinant human growth hormone (rhGH) self administered daily for one year.

Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total).

Overall Number of Participants Analyzed 5
Mean (Standard Deviation)
Unit of Measure: percent of body fat
38.74  (6.84)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Human Growth Hormone
Hide Arm/Group Description

recombinant human growth hormone (rhGH) self administered daily for one year.

Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total).

All-Cause Mortality
Human Growth Hormone
Affected / at Risk (%)
Total   0/15 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Human Growth Hormone
Affected / at Risk (%)
Total   0/15 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Human Growth Hormone
Affected / at Risk (%)
Total   0/15 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Name/Title: Randall Urban, MD
Organization: University of Texas Medical Branch
Phone: 409-772-1176
Responsible Party: The University of Texas Medical Branch, Galveston
ClinicalTrials.gov Identifier: NCT00957671     History of Changes
Other Study ID Numbers: 03-034
First Submitted: August 10, 2009
First Posted: August 12, 2009
Results First Submitted: February 1, 2018
Results First Posted: May 15, 2018
Last Update Posted: June 29, 2018