Effects of testosterone and growth hormone supplementation therapies on quality of life in older men: exploratory findings from the HORMA study

PDF

Download

Open document

Flip pages

Summarize

Download a page range

Download transcript

Copy asset link

Request this asset

Transcript (if available)

Content i

EFFECTS OF TESTOSTERONE AND GROWTH HORMONE SUPPLEMENTATION THERAPIES
ON QUALITY OF LIFE IN OLDER MEN: EXPLORATORY FINDINGS FROM THE HORMA
STUDY

by

Chris J. Hahn

A Thesis Presented to the
FACULTY OF THE GRADUATE SCHOOL
UNIVERSITY OF SOUTHERN CALIFORNIA
In Partial Fulfillment of the
Requirements for the Degree
MASTER OF SCIENCE
(APPLIED BIOSTATISTICS AND EPIDEMIOLOGY)

December 2008

Copyright 2008 Chris J. Hahn
ii

Dedication
To Valerie, without whose patience and understanding I would have been unable to complete
this manuscript.
iii

Acknowledgements
The author would like to acknowledge the entire HORMA clinical and data management team
for their careful administration and guidance of the study, especially Miwa Kawakubo for her
assistance with analysis of the hormone assay data and Ying Wang for her organization and
management of the entirety of the trial data.
iv

Table of Contents

Dedication ii

Acknowledgements iii

List of Tables v

List of Figures vi

Glossary vii

Abstract viii

Introduction 1
Declining Testosterone and Growth Hormone Levels 1
in Older Men
Health‐related Quality of Life 1

Methods 3
Study Design 3
Outcome Measures 4
Data Analysis 6

Results 7
Baseline Comparisons 7
Factorial and One Way ANOVA 8
Pearson’s Correlations 10

Discussion 12

References 14
v

List of Tables

Table 1: Baseline Characteristics and Comparisons 8

Table 2: Descriptive Statistics and ANOVA Results for Change 9
in QOL Variables by Group at Week 16

Table 3: Least Squares Means and Standard Errors for Change 9
in SF‐12 MCS from 10 g/day testosterone ANOVA Model,
by Recombinant Human Growth Hormone (rhGH)
Assignment, at Week 16

Table 4: Correlations of Change in QOL Outcomes with Change 11
in Serum Hormone Levels at Week 16
vi

List of Figures

Figure 1: Interaction Plot of Factorial ANOVA for Change in 10
SF‐12 MCS by Treatment Assignment

Figure 2: Correlation Plot of Change in SF‐12 MCS with Change 12
in IGF‐1
vii

Glossary

CV: Coefficient of variation

GH: Growth hormone

GnRH: Gonadotropin‐releasing hormone

IGF‐1: Insulin‐like growth factor 1

QOL: Quality of Life

rhGH: Recombinant human growth hormone

viii

Abstract
As men age, their testosterone and growth hormone axes decline and may be
associated with decrements in quality of life (QOL). Hormone replacement or
supplementation is one potential option to improve QOL. The HORMA study
investigates whether different levels of testosterone and human growth hormone
supplementation affect quality of life in 65‐90 year old men with low levels of
testosterone and IGF‐1 (a measure of GH status). In men who received a 10g/day dose
of testosterone to achieve youthful levels plus human growth hormone placebo showed
a decrease (p=0.02) in mental health‐related QOL whereas those who received a
5μg/kg/day of GH at the same dose of testosterone improved (p<0.05). Additionally,
among those who received testosterone at 10g/day, increased mental health‐related
QOL was positively correlated (r=0.33; p=0.02) with increasing serum IGF‐1. These
preliminary findings suggest testosterone and human growth hormone supplementation
may positively affect mental health‐related QOL in older men.
1

Introduction
Declining Testosterone and Growth Hormone Levels in Older Men
Declines in endogenous testosterone and growth hormone production are increasingly
common as men age (Gray, Feldman, McKinlay, & Longcope, 1991; A. D. Seftel, 2006)
and affect between 20‐50% of community dwelling older men (Gruenewald &
Matsumoto, 2003; Hijazi & Cunningham, 2005). Symptomology associated with this
decline are often considered common components of the aging process and can consist
of anxiety, depression, fatty weight gain, muscle atrophy, and infertility (Lunenfeld,
2003; A. Seftel, 2006). Clinical trials to investigate treatment options for declining
testosterone levels are numerous and report desirable outcomes including
improvements in strength (Page et al., 2005), body composition (Emmelot‐Vonk et al.,
2008), cognition (Cherrier, Craft, & Matsumoto, 2003), mood (Wang et al., 2000), sexual
function (Allan, Forbes, Strauss, & McLachlan, 2008), and bone density (Amory et al.,
2004).

Health‐related Quality of Life
Long standing attempts to quantify and develop instruments for the measurement of
health‐related quality of life (QOL), such as the Medical Outcomes Study in the United
States (Tarlov et al., 1989) and the EuroQol Group that originally encompassed five
countries in Europe (Brooks, 1996; "EuroQol‐‐a new facility for the measurement of
health‐related quality of life. The EuroQol Group," 1990), are well documented and
2

detailed within the current medical and social sciences literature. Further evidence of
the imperative to develop valid and reliable instruments for the measurement of health‐
related quality of life can be evidenced by the number of funding opportunities provided
by the National Institutes of Health (NIH) for the topic. A query of CRISP (an acronym for
Computer Retrieval of Information on Scientific Projects, a searchable database of
federally funded biomedical research projects) for the term “health‐related quality of
life” reveals, for fiscal year 2008 alone, 2203 projects with the term in their title or
abstract. Further, a return of 3587 instances is achieved when the search is broadened
to the term “quality of life.”

Research to investigate and understand how declining levels of testosterone and growth
hormone affect quality of life are limited (Moncada, 2006). Some efforts are under way
to develop quality of life instruments that specifically address issues relating to very low
levels of testosterone and symptoms of hypogonadism in older men (Novak, Brod, &
Elbers, 2002), yet more general health‐related QOL measures have proven useful.
Specifically, the SF‐12 and SF‐36 instruments have shown health‐related quality of life
improvements in growth hormone‐ and testosterone‐based treatment interventions for
individuals with low levels of these hormones (Giannoulis et al., 2006; Urushihara,
Fukuhara, Tai, Morita, & Chihara, 2007). Improvements in health‐related quality of life
are often not primary outcomes for large phase III clinical trials of testosterone
replacement treatments. However, there is evidence that testosterone provides mental
3

health benefits through various physiologic avenues (Barrett‐Connor, Goodman‐Gruen,
& Patay, 1999; Fink, Sumner, McQueen, Wilson, & Rosie, 1998) though the mechanism
is uncertain.

Methods
Study Design
The Hormonal Regulators of Muscle and Metabolism (HORMA) Study was a randomized,
placebo‐controlled, double blind phase III clinical trial to investigate testosterone
replacement and rhGH supplementation in community dwelling older men with low
levels of testosterone and IGF‐1 (Schroeder et al., 2007). Randomization was two tiered,
with the first tier for testosterone replacement assignment and second tier for rhGH
supplementation level producing a 2X3 factorial design. Enrollment commenced in June
2003, and the study closed with the final participant evaluation in May 2007.

To assure generalizability of outcomes, subjects were evaluated and managed at the
University of Southern California (Los Angeles, CA), Tufts University (Boston, MA), and
Washington University (Saint Louis, MO) so as to provide geographic diversity of the
study population. All participants provided IRB approved informed consent prior to
screening for inclusion. To participate, men were required to 1) be aged 65‐90 years, 2)
have serum IGF‐1 in the lower tertile for adults (less than 167 ng/mL), and 3) have
morning total serum in the lower half of the adult male range (150‐550 ng/dL).
4

Additional safety criteria required participants to have 1) prostate specific antigen (PSA)
less than or equal to 4.0 ng/mL, 2) hematocrit less than or equal to 50%, and 3) fasting
blood glucose less than 126 mg/dL.

All participants were treated with a novel Leydig cell clamp with long‐acting GnRH
agonist (leuprolide acetate depot, 7.5mg intramuscularly; TAP Pharmaceutical Products
Inc.) to suppress endogenous testosterone production. The two testosterone
assignments were self‐administered each morning via 1% testosterone transdermal gel
(Solvay Pharmaceuticals Inc.) for 16 weeks. One consisted of a 10g/day dose (groups A‐
C), meant to produce a mid‐ to high‐ level of serum testosterone typical of younger
men, and the other a 5g/day dose (groups D‐F), meant to produce a low normal level
typical of older men. Recombinant human growth hormone was self administered at
doses of 0, 3, and 5 μg/kg/day (groups A/D, B/E, and C/F, respectively) via subcutaneous
injections two‐to‐three hours after dinner each evening (Genentech Inc). The
supplementation of growth hormone was intended to increase whole body protein
synthesis, with the highest dose intended to provide an increased stimulus but both
active doses were chosen to minimize adverse effects.

Outcome Measures
Quality of life measures were completed by the participant during baseline and week 16
evaluation. Three instruments were self‐administered: 1) the 12‐item Short‐Form Health
5

Survey version 1 (SF‐12), 2) the Physical Activity Scale for the Elderly (PASE), and 3) the
Geriatric Depression Scale (GDS). The SF‐12 is a validated shortened version of the SF‐36
that reliably reproduces mental and physical health‐related quality of life component
scores (Ware, Kosinski, & Keller, 1996). It is intended to be self‐administered and can be
completed, on average, in less than two minutes. The PASE is a validated survey
designed to assess physical activity in older individuals (Washburn, McAuley, Katula,
Mihalko, & Boileau, 1999; Washburn, Smith, Jette, & Janney, 1993). It is intended to be
completed in less than five minutes and draws from information on leisure, household,
and occupational activity. The GDS is a reliable and valid instrument intended
specifically for rating depression in the elderly (Yesavage et al., 1983).

Hormone assays were performed using two different methods and at two different
times. For screening, total testosterone was measured by immunoassays in the local
clinical university laboratories and IGF‐1 at Quest Diagnostics. After the completion of
the study, baseline and week 16 measurements of testosterone and IGF‐1 were
obtained via batch testing of serum samples. For testosterone, samples were tested
using a validated liquid chromatography‐tandem mass spectrometry assay (ref) at
Boston Medical Center (inter‐assay CVs at 250 and 500 ng/dL were 5% and 3% and intra‐
assay CV 3% and 2%, respectively). IGF‐1 levels were determined in the USC GCRC
Endocrine Core Laboratory and analyzed using an automated immunoassay analyzer
6

(Immulite 1000, Siemans Healthcare Diagnostics, Deerfield, IL; sensitivity=2.6nmol/L
(20ng/ml), inter‐assay CV=3.6% and intra‐assay CV=6.6%).

The primary outcomes consisted of body composition (muscle mass and body fat),
muscle performance, and aerobic capacity measures that are fully described elsewhere
(Sattler et al.).

Data Analysis
All analyses contained in this manuscript were exploratory in nature and the study was
not powered to detect a difference in any quality of life questionnaire outcome. Power
calculations were based on demonstrating significant improvements in skeletal
musculature protein synthesis. Baseline comparisons across the six treatment groups
were evaluated using one‐way ANOVA models and Chi‐Square tests, for continuous and
discrete variables, respectively. The effects of testosterone and rhGH assignment on
change after 16 weeks in the four QOL outcomes were modeled using two‐way factorial
ANOVA. If an interaction between groups was detected, one‐way ANOVA models and
independent t‐tests were employed to detect differences between and within groups
for individual strata. Wald tests were used to assess linear trends across groups and
paired t‐tests were used to determine statistically significant change for post‐hoc
comparisons of means within groups. Tukey‐Kramer methods were used to adjust for all
multiple comparisons. Pearson’s correlation was computed to assess the relationship
7

between changes in normally distributed continuous QOL scores and hormone levels.
Statistical analyses were carried out at the 0.05 level using the Statistical Analysis
System 9.1 (SAS Institute Inc, Cary, NC).

Results
Baseline Comparisons
The HORMA study consented and screened 242 participants, of which 122 were
enrolled and randomly assigned to receive study therapies according to the 2X3 factorial
design. One hundred and twelve of the 122 participants completed the week 16
evaluation, of which 105 provided baseline and week 16 responses to the SF‐12, 111 to
the GDS, and 94 to the PASE. All inclusion criteria at screening and outcomes at baseline
were similar for the six different treatment assignment groups (Table 1).

8

Table 1: Baseline Characteristics and Comparisons
Baseline Variable
Group A
(n=19)
Group B
(n=19)
Group C
(n=20)
Group D
(n=20)
Group E
(n=17)
Group F
(n=17)
ANOVA
or χ
2

Age (SD), years
72.7
(5.1)
71.3
(3.9)
70.0
(4.1)
70.2
(4.6)
69.9
(3.2)
70.5
(3.9)
0.32
Geographic location 0.99
  California 9 10 9 9 8 8
  Massachusetts 6 5 7 7 6 4
  Missouri 4 4 4 4 3 5
Serum Testosterone
(SD), ng/dL
385
(106)
377
(103)
373
(89)
350
(98)
359
(89)
311
(94)
0.24
Serum IGF‐1 (SD),
ng/dL
101
(23)
109
(24)
115
(31)
105
(32)
127
(30)
114
(32)
0.11
PSA (SD), ng/mL
1.8
(1.0)
1.3
(0.7)
1.5
(1.0)
1.4
(0.8)
1.7
(0.8)
1.4
(0.9)
0.45
Hematocrit (SD), %
43.3
(3.5)
43.3
(1.6)
44.1
(2.5)
42.1
(2.9)
43.2
(2.7)
43.2
(2.2)
0.34
Fasting blood glucose
(SD), mg/dL
92
(9)
93
(8)
93
(10)
89
(9)
92
(18)
94
(9)
0.78
GDS score (SD)
2.58
(2.93)
2.84
(3.04)
3.45
(3.98)
2.20
(2.89)
3.12
(3.82)
2.54
(1.97)
0.86
PASE score (SD)
156.2
(71.6)
156.9
(79.5)
134.3
(54.9)
137.5
(67.7)
172.1
(48.1)
126.1
(61.8)
0.33
PCS score (SD)
51.34
(4.44)
52.54
(5.27)
53.19
(4.79)
50.93
(8.28)
51.52
(5.78)
52.16
(5.65)
0.85
MCS score (SD)
57.03
(4.89)
55.75
(7.96)
53.45
(6.39)
57.74
(3.61)
55.19
(6.01)
56.47
(4.31)
0.26

Factorial and One Way ANOVA
Overall levels of significance for change in PASE, GDS, and SF‐12 physical component
score (PCS) were nonsignificant (Table 2). Overall and interaction effects for SF‐12
mental component score (MCS) was marginally significant (p<0.08), which suggested
stratified modeling by assigned testosterone dose (see Figure 1 for interaction plot).
Results of these one‐way ANOVA models were nonsignificant for the low dose
testosterone (5g/day) group. However, the high dose testosterone group (10g/day)
obtained overall significance (p=0.01), a significant linear trend (p=0.004), and
9

significant post‐hoc differences between the 0 μg/kg/day and 5 μg/kg/day groups
(p=.01). Both least squares means for these rhGH groups were significantly different
than zero (p<0.05; see Table 3).

Table 2: Descriptive Statistics and ANOVA Results for Change in QOL
Variables by Group at Week 16
QOL
Variable
Group A
(n=19)
Group B
(n=19)
Group C
(n=20)
Group D
(n=20)
Group E
(n=17)
Group F
(n=17)
ANOVA
(Interaction)
ΔGDS (SD)
‐0.04
(2.10)
0.58
(3.64)
‐0.75
(2.02)
0.53
(3.36)
0.30
(1.86)
‐0.37
(1.11)
0.53
(0.75)
ΔPASE (SD)
16.8
(72.6)
19.7
(53.6)
6.7
(47.8)
17.8
(94.5)
‐16.2
(80.5)
‐7.8
(41.7)
0.58
(0.57)
ΔPCS (SD)
‐0.15
(4.41)
‐0.77
(6.58)
‐1.15
(5.34)
‐0.58
(5.36)
1.76
(3.66)
‐2.95
(7.47)
0.33
(0.27)
ΔMCS (SD)
0.75
(4.46)
‐1.43
(5.50)
0.88
(6.88)
‐2.71
(5.46)
0.23
(3.40)
2.57
(5.62)
0.08
(0.07)

Table 3: Least Squares Means and Standard Errors for Change in SF‐12
MCS from 10 g/day testosterone ANOVA Model, by Recombinant Human
Growth Hormone (rhGH) Assignment, at Week 16
rhGH Assignment n per Group
Least Squares
Mean Standard Error Paired t‐test
0 μg/kg/day 20 ‐2.71 1.16 0.02
3 μg/kg/day 17 0.23 1.24 0.85
5 μg/kg/day 17 2.57 1.28 <0.05

10

Figure 1: Interaction Plot of Factorial ANOVA for Change in SF‐12 MCS by
Treatment Assignment

Pearson’s Correlations
We performed additional analyses of change in QOL measures with change in measured
level of hormones, as opposed to assigned treatment groups, based upon the
interaction, significant difference, and linear trends in the ANOVA models. Correlations
of the entire study population between the two hormones (testosterone and IGF‐1) and
11

the four QOL measures (GDS, PASE, PCS, and MCS) were not significant (p>0.05; see
Table 4).

Table 4: Correlations of Change in QOL Outcomes with Change in Serum
Hormone Levels at Week 16
Hormone
ΔGDS
(n=111)
ΔPASE
(n=94)
ΔSF‐12 PCS
(n=105)
ΔSF‐12 MCS
(n=105)
Change in serum testosterone 0.07 0.18 ‐0.06 ‐0.01
Change in serum IGF‐1 ‐0.08 ‐0.13 ‐0.01 0.10

Additional correlations were performed for MCS with IGF‐1 due to the observed
stratification from the ANOVA model of MCS outcome by testosterone assignment. The
sample was restricted to those with a measured change in testosterone greater than the
median for the study population (174 ng/dL {range ‐497 to +1855} i.e. equal to an
increase of at least 175 ng/dL from baseline). The result was a moderately positive
correlation between the two variables (n=50, Pearson’s r=0.33, p=0.02; see Figure 2).

12

Figure 2: Correlation Plot of Change in SF‐12 MCS with Change in IGF‐1

Discussion
The HORMA study was the first to investigate the combined effect of transdermal
testosterone and injectable growth hormone supplementation over 16 weeks in elderly
community dwelling men. Gains in skeletal muscle mass and performance as well as
losses in body fat were demonstrated in analyses of the study primary outcomes (Sattler
et al., 2008).
13

As the study sample size was only powered a priori to detect changes in myofibrillar
protein synthesis, the investigation of changes in quality of life was exploratory. Indeed,
the initial interaction effect between growth hormone treatment group and
testosterone treatment group in the factorial ANOVA model was not significant at the
0.05 level. However, given some evidence in the literature suggesting effects of growth
hormone supplementation on quality of life, we conducted a stratified analysis by
testosterone dose. Further studies with appropriate sample size and power levels based
upon SF‐12 MCS variance reported in this study should confirm these findings.

In conclusion, older men with low levels of testosterone respond differently to rhGH
supplementation when administered supplemental testosterone designed to restore
youthful levels (ie 10 g/day dosing). At this rejuvenated level, 5 μg/kg/day of rhGH
improved mental health quality of life while a 0 μg/kg/day decreased it. This
relationship did not appear to exist at the lower testosterone levels typical of older
community dwelling men. Future studies that provide larger sample sizes for
appropriate power and with primary outcomes focused on quality of life, as suggested
by findings from the HORMA study, will be a necessary step to further explore the
potential value of replacement doses of these two anabolic hormones on aspects of
quality of life.
14

References

Allan, C. A., Forbes, E. A., Strauss, B. J., & McLachlan, R. I. (2008). Testosterone therapy
increases sexual desire in ageing men with low‐normal testosterone levels and
symptoms of androgen deficiency. Int J Impot Res, 20(4), 396‐401.

Amory, J. K., Watts, N. B., Easley, K. A., Sutton, P. R., Anawalt, B. D., Matsumoto, A. M.,
et al. (2004). Exogenous testosterone or testosterone with finasteride increases
bone mineral density in older men with low serum testosterone. J Clin Endocrinol
Metab, 89(2), 503‐510.

Barrett‐Connor, E., Goodman‐Gruen, D., & Patay, B. (1999). Endogenous sex hormones
and cognitive function in older men. J Clin Endocrinol Metab, 84(10), 3681‐3685.

Brooks, R. (1996). EuroQol: the current state of play. Health Policy, 37(1), 53‐72.

Cherrier, M. M., Craft, S., & Matsumoto, A. H. (2003). Cognitive changes associated with
supplementation of testosterone or dihydrotestosterone in mildly hypogonadal
men: a preliminary report. J Androl, 24(4), 568‐576.

Emmelot‐Vonk, M. H., Verhaar, H. J., Nakhai Pour, H. R., Aleman, A., Lock, T. M., Bosch,
J. L., et al. (2008). Effect of testosterone supplementation on functional mobility,
cognition, and other parameters in older men: a randomized controlled trial.
JAMA, 299(1), 39‐52.

EuroQol‐‐a new facility for the measurement of health‐related quality of life. The
EuroQol Group. (1990). Health Policy, 16(3), 199‐208.

Fink, G., Sumner, B. E., McQueen, J. K., Wilson, H., & Rosie, R. (1998). Sex steroid control
of mood, mental state and memory. Clin Exp Pharmacol Physiol, 25(10), 764‐775.

Giannoulis, M. G., Sonksen, P. H., Umpleby, M., Breen, L., Pentecost, C., Whyte, M., et al.
(2006). The effects of growth hormone and/or testosterone in healthy elderly
men: a randomized controlled trial. J Clin Endocrinol Metab, 91(2), 477‐484.

Gray, A., Feldman, H. A., McKinlay, J. B., & Longcope, C. (1991). Age, disease, and
changing sex hormone levels in middle‐aged men: results of the Massachusetts
Male Aging Study. J Clin Endocrinol Metab, 73(5), 1016‐1025.

15

Gruenewald, D. A., & Matsumoto, A. M. (2003). Testosterone supplementation therapy
for older men: potential benefits and risks. J Am Geriatr Soc, 51(1), 101‐115;
discussion 115.

Hijazi, R. A., & Cunningham, G. R. (2005). Andropause: is androgen replacement therapy
indicated for the aging male? Annu Rev Med, 56, 117‐137.

Lunenfeld, B. (2003). Androgen therapy in the aging male. World J Urol, 21(5), 292‐305.

Moncada, I. (2006). Testosterone and men's quality of life. Aging Male, 9(4), 189‐193.

Novak, A., Brod, M., & Elbers, J. (2002). Andropause and quality of life: findings from
patient focus groups and clinical experts. Maturitas, 43(4), 231‐237.

Page, S. T., Amory, J. K., Bowman, F. D., Anawalt, B. D., Matsumoto, A. M., Bremner, W.
J., et al. (2005). Exogenous testosterone (T) alone or with finasteride increases
physical performance, grip strength, and lean body mass in older men with low
serum T. J Clin Endocrinol Metab, 90(3), 1502‐1510.

Sattler, F. R., Castaneda‐Sceppa, C., Binder, E. F., Schroeder, E. T., Wang, Y., Bhasin, S., et
al. (2008). Testosterone and Growth Hormone Improve Body Composition and
Muscle Performance in Older Men: The HORMA Trial, presented at the 3rd
International Academy on Nutrition and Aging (IANA) Meeting. J Nutr Health
Aging, 12(7), 422‐426.

Sattler, F. R., Castaneda‐Sceppa, C., Binder, E. F., Schroeder, E. T., Wang, Y., Bhasin, S., et
al. Testosterone and Growth Hormone Improve Body Composition and Muscle
Performance in Older Men: A Randomized Trial. Manuscript submitted for
publication.

Schroeder, E. T., Castaneda‐Sceppa, C., Wang, Y., Binder, E. F., Kawakubo, M., Stewart,
Y., et al. (2007). Hormonal regulators of muscle and metabolism in aging
(HORMA): design and conduct of a complex, double masked multicenter trial.
Clin Trials, 4(5), 560‐571.

Seftel, A. (2006). Male hypogonadism. Part II: etiology, pathophysiology, and diagnosis.
Int J Impot Res, 18(3), 223‐228.

Seftel, A. D. (2006). Male hypogonadism. Part I: Epidemiology of hypogonadism. Int J
Impot Res, 18(2), 115‐120.

16

Tarlov, A. R., Ware, J. E., Jr., Greenfield, S., Nelson, E. C., Perrin, E., & Zubkoff, M. (1989).
The Medical Outcomes Study. An application of methods for monitoring the
results of medical care. JAMA, 262(7), 925‐930.

Urushihara, H., Fukuhara, S., Tai, S., Morita, S., & Chihara, K. (2007). Heterogeneity in
responsiveness of perceived quality of life to body composition changes between
adult‐ and childhood‐onset Japanese hypopituitary adults with GH deficiency
during GH replacement. Eur J Endocrinol, 156(6), 637‐645.

Wang, C., Swerdloff, R. S., Iranmanesh, A., Dobs, A., Snyder, P. J., Cunningham, G., et al.
(2000). Transdermal testosterone gel improves sexual function, mood, muscle
strength, and body composition parameters in hypogonadal men. J Clin
Endocrinol Metab, 85(8), 2839‐2853.

Ware, J., Jr., Kosinski, M., & Keller, S. D. (1996). A 12‐Item Short‐Form Health Survey:
construction of scales and preliminary tests of reliability and validity. Med Care,
34(3), 220‐233.

Washburn, R. A., McAuley, E., Katula, J., Mihalko, S. L., & Boileau, R. A. (1999). The
physical activity scale for the elderly (PASE): evidence for validity. J Clin
Epidemiol, 52(7), 643‐651.

Washburn, R. A., Smith, K. W., Jette, A. M., & Janney, C. A. (1993). The Physical Activity
Scale for the Elderly (PASE): development and evaluation. J Clin Epidemiol, 46(2),
153‐162.

Yesavage, J. A., Brink, T. L., Rose, T. L., Lum, O., Huang, V., Adey, M., et al. (1983).
Development and validation of a geriatric depression screening scale: a
preliminary report. J Psychiatr Res, 17(1), 37‐49.

Abstract (if available)

Abstract As men age, their testosterone and growth hormone axes decline and may be associated with decrements in quality of life (QOL). Hormone replacement or supplementation is one potential option to improve QOL. The HORMA study investigates whether different levels of testosterone and human growth hormone supplementation affect quality of life in 65-90 year old men with low levels of testosterone and IGF-1 (a measure of GH status). In men who received a 10g/day dose of testosterone to achieve youthful levels plus human growth hormone placebo showed a decrease (p=0.02) in mental health-related QOL whereas those who received a 5μg/kg/day of GH at the same dose of testosterone improved (p<0.05). Additionally, among those who received testosterone at 10g/day, increased mental health-related QOL was positively correlated (r=0.33

Linked assets

University of Southern California Dissertations and Theses

Conceptually similar

PDF

Association between informed decision-making and mental health-related quality of life in long term prostate cancer survivors

Asset Metadata

Creator Hahn, Chris J. (author)

Core Title Effects of testosterone and growth hormone supplementation therapies on quality of life in older men: exploratory findings from the HORMA study

School Keck School of Medicine

Degree Master of Science

Degree Program Applied Biostatistics

Publication Date 12/05/2008

Defense Date 11/03/2008

Publisher University of Southern California (original), University of Southern California. Libraries (digital)

Tag Growth Hormone,OAI-PMH Harvest,Quality of life,testosterone

Language English

Contributor Electronically uploaded by the author (provenance)

Advisor Azen, Stanley Paul (committee chair), Sattler, Fred R. (committee member), Xiang, Anny Hui (committee member)

Creator Email chrishah@gmail.com,chrishah@usc.edu

Permanent Link (DOI) https://doi.org/10.25549/usctheses-m1876

Unique identifier UC1298605

Identifier etd-Hahn-2549 (filename),usctheses-m40 (legacy collection record id),usctheses-c127-128448 (legacy record id),usctheses-m1876 (legacy record id)

Legacy Identifier etd-Hahn-2549.pdf

Dmrecord 128448

Document Type Thesis

Rights Hahn, Chris J.

Type texts

Source University of Southern California (contributing entity), University of Southern California Dissertations and Theses (collection)

Repository Name Libraries, University of Southern California

Repository Location Los Angeles, California

Repository Email cisadmin@lib.usc.edu