NIH Looking for a Few Good Old Men with Low
Testosterone to Join Clinical Trial
National clinical trial will determine if low
testosterone causes serious problems in senior citizens
Nov. 4, 2009 A new clinical trial is seeking men
age 65 and older to help determine if low testosterone contributes to
serious problems in older men, including a decrease in the ability to
walk, loss of muscle mass, less strength, decreased vitality, decreased
sexual function, impaired cognition, cardiovascular disease and anemia.
Many of these have become accepted results of "aging."
Testosterone normally decreases with age, but in
some men, low levels of testosterone may contribute to these
debilitating conditions. The new national clinical trial will test
whether these conditions can be favorably affected by testosterone
therapy.
One-point decrease on social activity scale was
equivalent to being approximately five years older at the start of the
study - risk of death, disability jump
The National Institute on Aging (NIA), part of the
National Institutes of Health, this week announced the start of this
large-scale clinical trial to evaluate the effect of testosterone
therapy on older men.
Led by the University of Pennsylvania School of
Medicine and conducted at 12 sites across the nation, the Testosterone
Trial will involve 800 men age 65 and older with low testosterone
levels.
"We know that, as men get older, a significant
proportion are unable to carry out activities of daily living and
experience decreased physical and cognitive function and decreased
independence," said NIA Director Richard J. Hodes, M.D.
"We do not know the extent to which low levels of
testosterone may contribute to these conditions."
A 2004 report by the Institute of Medicine,
"Testosterone and Aging: Clinical Research Directions," noted
several important unanswered questions about the effects of testosterone
therapy. The NIA is aiming to answer these questions by testing the
effectiveness of testosterone therapy in older men with low testosterone
levels and one of the following conditions: impaired walking, low
vitality, sexual or cognitive dysfunction.
A key consideration is the use of testosterone as a
therapy for certain conditions, rather than as a preventive measure.
The NIA is the primary source of support for this
trial. Additional funding is being provided by the National Heart, Lung,
and Blood Institute (NHLBI); the National Institute on Neurological
Disorders and Stroke (NINDS); the Eunice Kennedy Shriver National
Institute of Child Health and Human Development (NICHD) and Solvay
Pharmaceuticals, which is also supplying the study drug.
The Testosterone Trial will include five separate
studies.
At each of the 12 sites, men 65 and older with low
serum testosterone and at least one of the following conditions
anemia, decreased physical function, low vitality, impaired cognition or
reduced sexual function will be randomly assigned to participate in a
treatment group or a control group.
About The Testosterone Trial
The National Institutes of Health (NIH) has
launched a clinical trial to determine if testosterone treatment
of men aged 65 and older will help their walking, vitality,
sexual function, memory, blood count, and cardiovascular risk.
This trial, called The Testosterone Trial, or TTrial, will be
conducted in 800 men in 12 cities across the United States.
Why is The Testosterone Trial being
Conducted?
As men age their blood testosterone levels
fall, and also they find it more difficult to walk, have less
energy, have less interest in sex, have greater difficulty
remembering, and tend to be anemic, as well as greater risk of
cardiovascular disease. It is possible that low blood
testosterone is a cause of these problems.
The purpose of The Testosterone Trial is to
determine if testosterone treatment of men who are 65 years and
older and who have a low blood testosterone and one or more of
these problems will improve them.
What Will Happen in The Testosterone
Trial?
Men who are age 65 and older and have low
blood testosterone may be eligible for this trial if they also
have one or more of the following: difficulty walking a quarter
of a mile, less interest in sex, or less vitality than they used
to have.
Men who are interested will be tested by
blood tests and questionnaires to see if they qualify.
Men who qualify will be assigned to use
either testosterone gel or placebo gel daily for one year.
During this year men will be tested by
questionnaires and blood tests to determine if their walking,
interest in sex, energy, memory and blood count are getting
better.
How Can I Learn More about The
Testosterone Trial?
If you are interested in learning more
about The Testosterone Trial, click on
Is This Trial for Me? .
Treatment groups will be given a testosterone gel
that is applied to the torso, abdomen, or upper arms; control groups
will receive a placebo gel. Serum testosterone will be measured monthly
for the first three months and quarterly thereafter up to one year.
Participants will be tested on a wide range of
measures to evaluate physical function, vitality, cognition,
cardiovascular disease, and sexual function.
"This study is important because testosterone
products have been marketed for many years as treatments for a variety
of conditions," said Evan C. Hadley, M.D., director of NIAs Division of
Geriatrics and Clinical Gerontology, which is the primary funder of the
trial.
"We hope this trial will establish whether
testosterone therapy results in clear benefits for older men."
The University of Pennsylvania School of Medicine
as the lead institution for the trial and will serve as coordinating
center for the study sites. Peter J. Snyder, M.D., professor of medicine
in the Division of Endocrinology, Diabetes and Metabolism at Penn, is
the principal investigator and will oversee trial activities.
"This is
an unprecedented opportunity for older men to learn more about
themselves and at the same time help find out if testosterone will
improve some of the afflictions of old age," said Dr. Snyder.
Recruitment of study participants will begin in
November of 2009. Men age 65 and older who are interested in
participating should call the site closest to them. Men living within a
50-mile radius of the study centers, listed below, are especially
encouraged to participate.
Participating institutions and their phone numbers
include:
●
University of California, Los Angeles; 310-222-5297
●
University of California, San Diego; 877-219-6610
●
Boston University; 617-414-2968
●
University of Pittsburgh; 800-872-3653
●
Albert Einstein College of Medicine, Bronx, N.Y.; 718-405-8271
●
Baylor College of Medicine, Houston, Texas; 713-798-8343
●
University of Minnesota, Minneapolis; 612-625-4449
●
Yale University, New Haven, Conn.; 203-737-5672
●
University of Alabama at Birmingham; 205-934-2294
●
VA Puget Sound Health Care System and University of Washington School of
Medicine, Seattle; 206-768-5408
The NHLBI plans, conducts, and supports research
related to the causes, prevention, diagnosis, and treatment of heart,
blood vessel, lung, and blood diseases; and sleep disorders. The
Institute also administers national health education campaigns on women
and heart disease, healthy weight for children, and other topics. NHLBI
press releases and other materials are available online at
www.nhlbi.nih.gov.
The NINDS (www.ninds.nih.gov)
is the nations leading funder of research on the brain and nervous
system. The NINDS mission is to reduce the burden of neurological
disease a burden borne by every age group, by every segment of
society, by people all over the world.
The NICHD sponsors research on development, before
and after birth; maternal, child, and family health; reproductive
biology and population issues; and medical rehabilitation. For more
information, visit the Institute's Web site at
http://www.nichd.nih.gov/.
The NIA leads the federal effort supporting and
conducting research on aging and the medical, social and behavioral
issues of older people. For more information on research and aging, go
to
www.nia.nih.gov.
The National Institutes of Health (NIH) The
Nation's Medical Research Agency includes 27 Institutes and Centers
and is a component of the U.S. Department of Health and Human Services.
It is the primary federal agency for conducting and supporting basic,
clinical and translational medical research, and it investigates the
causes, treatments, and cures for both common and rare diseases. For
more information about NIH and its programs, visit
www.nih.gov.
Keep up with the latest news for senior citizens, baby
boomers
Nov. 4, 2009 A new clinical trial is seeking men
age 65 and older to help determine if low testosterone contributes to
serious problems in older men, including a decrease in the ability to
walk, loss of muscle mass, less strength, decreased vitality, decreased
sexual function, impaired cognition, cardiovascular disease and anemia.
Many of these have become accepted results of "aging."