Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
140 participants
INTERVENTIONAL
2001-11-30
2007-07-31
Brief Summary
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Detailed Description
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Bone mineral density (BMD) by dual x-ray absorptiometry (DXA), will be performed at baseline and yearly to assess changes in BMD. Blood and urine samples will be collected at baseline and yearly; these tests will be correlated to changes in BMD.
To determine the effects of testosterone on frailty, strength of the upper and lower extremities will be measured every 6 months using the hand-held dynamometer and sitting leg press, respectively. Changes in lean body mass and percent body fat will be measured by total body DXA at baseline, 6 months and then annually. In addition, physical performance, emotional and sexual function, and disability will be assessed also.
The safety of testosterone supplementation on prostate and cardiovascular parameters will also be monitored; participants will be screened for prostate cancer at baseline, 6 months then yearly for 2 years. Fasting lipoprotein levels will be measured yearly while on testosterone replacement, and cardiovascular specific adverse effects such as angina, myocardial infarction, stroke and sudden death will be tracked.
Conditions
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Keywords
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
DOUBLE
Interventions
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testosterone
Eligibility Criteria
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Inclusion Criteria
* Total testosterone levels below 375 ng/dl or bioavailable testosterone levels at least 1.5 SD lower than the young adult mean
* Able to come or be brought to the University of Connecticut Health Center (UCHC) for outpatient visits
Exclusion Criteria
* Disease of bone metabolism (i.e., Paget's disease, osteomalacia, hyperparathyroidism)
* History of pituitary disease
* History of sleep apnea
* Consumption of more than 3 alcoholic drinks/day
* Use of androgen, estrogen, or DHEA in the preceding year
* Use of antiresorptive agents such as calcitonin or bisphosphonates
* Metastatic or advanced cancer
* Current chemotherapy or radiation treatment
* Plans to move in the next three years
* Advanced liver or renal disease such that the subjects is unlikely to complete the three year intervention
* Hemaglobin \>16.5 g/dl
* Bilateral hip replacement or repair
60 Years
MALE
No
Sponsors
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National Institute on Aging (NIA)
NIH
Principal Investigators
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Anne Kenny, MD
Role: PRINCIPAL_INVESTIGATOR
Center on Aging, University of Connecticut Health Center
Locations
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Center on Aging, University of Connecticut Health Center
Farmington, Connecticut, United States
Countries
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References
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Tenover JL. Testosterone and the aging male. J Androl. 1997 Mar-Apr;18(2):103-6.
Morley JE, Perry HM 3rd, Kaiser FE, Kraenzle D, Jensen J, Houston K, Mattammal M, Perry HM Jr. Effects of testosterone replacement therapy in old hypogonadal males: a preliminary study. J Am Geriatr Soc. 1993 Feb;41(2):149-52. doi: 10.1111/j.1532-5415.1993.tb02049.x.
Snyder PJ, Peachey H, Hannoush P, Berlin JA, Loh L, Holmes JH, Dlewati A, Staley J, Santanna J, Kapoor SC, Attie MF, Haddad JG Jr, Strom BL. Effect of testosterone treatment on bone mineral density in men over 65 years of age. J Clin Endocrinol Metab. 1999 Jun;84(6):1966-72. doi: 10.1210/jcem.84.6.5741.
Kenny AM, Prestwood KM, Gruman CA, Marcello KM, Raisz LG. Effects of transdermal testosterone on bone and muscle in older men with low bioavailable testosterone levels. J Gerontol A Biol Sci Med Sci. 2001 May;56(5):M266-72. doi: 10.1093/gerona/56.5.m266.
Kenny AM, Bellantonio S, Gruman CA, Acosta RD, Prestwood KM. Effects of transdermal testosterone on cognitive function and health perception in older men with low bioavailable testosterone levels. J Gerontol A Biol Sci Med Sci. 2002 May;57(5):M321-5. doi: 10.1093/gerona/57.5.m321.
Kenny AM, Prestwood KM, Gruman CA, Fabregas G, Biskup B, Mansoor G. Effects of transdermal testosterone on lipids and vascular reactivity in older men with low bioavailable testosterone levels. J Gerontol A Biol Sci Med Sci. 2002 Jul;57(7):M460-5. doi: 10.1093/gerona/57.7.m460.
Kenny AM, Kleppinger A, Annis K, Rathier M, Browner B, Judge JO, McGee D. Effects of transdermal testosterone on bone and muscle in older men with low bioavailable testosterone levels, low bone mass, and physical frailty. J Am Geriatr Soc. 2010 Jun;58(6):1134-43. doi: 10.1111/j.1532-5415.2010.02865.x.
Other Identifiers
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AG0043
Identifier Type: -
Identifier Source: org_study_id