TOM: Testosterone in Older Men With Sarcopenia - Full Text View

Sponsor:	Boston Medical Center
Collaborator:	National Institute on Aging (NIA)
Information provided by:	Boston Medical Center
ClinicalTrials.gov Identifier:	NCT00240981

Purpose

The purpose of this study is to determine whether testosterone replacement in older men with low testosterone levels will increase muscle strength, improve physical performance and overall sense of well being, and reduce fatigue.

Condition	Intervention	Phase
Sarcopenia Hypogonadism Muscular Diseases	Drug: Topical testosterone gel 1% (active formulation) Drug: Topical gel (placebo formulation)	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Testosterone Replacement for Older Men With Sarcopenia

Resource links provided by NLM:

MedlinePlus related topics: Fatigue Muscle Disorders

Drug Information available for: Testosterone Propionate Methyltestosterone Testosterone Oxymesterone Testosterone enanthate Testosterone undecanoate

U.S. FDA Resources

Further study details as provided by Boston Medical Center:

Primary Outcome Measures:

Changes in physical performance measured by an exercise testing regimen [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Changes in disability, fatigue, affect, and sense of well being assessed by validated questionnaires [ Time Frame: baseline, 3 months, and 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	210
Study Start Date:	January 2005
Study Completion Date:	December 2009
Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: Topical testosterone gel 1% (active formulation) Starting dose 10 g/day; increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day. Other Name: Testim®
Placebo Comparator: 2	Drug: Topical gel (placebo formulation) Starting dose 15 g/day (3 tubes), applied to upper arms and shoulders each day.

Detailed Description:

The primary objective of this study is to determine whether testosterone replacement in older men, who have low testosterone levels and mild to moderate physical impairment, will increase their maximal voluntary muscle strength of major upper and lower extremity muscle groups. The second objective is to determine whether testosterone replacement will improve the power of knee extension, physical performance tests, the level of physical activity (measured by 3D accelerometer), self-reported disability, exercise tolerance and mobility. The third objective is to determine whether testosterone supplementation improves fatigue, affect, and overall sense of well being in older men with low testosterone levels. A fourth objective is to define the Minimum Clinically Important Differences in physical measures perceived by the participants (MCID).

Participant involvement will require 15-17 clinic visits over 28 weeks. Five to 7 of these visits are for physical testing, including body composition, muscle performance, and physical function. Throughout the study, hormone measurements will be obtained.

Eligibility

Ages Eligible for Study:	65 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Community dwelling, ages 65 and older
Self-reported difficulty in climbing 10 steps without resting, or difficulty in walking 2 or 3 blocks outside on level ground
A score of 4 to 9 on the Short Physical Performance Battery (mild to moderate physical impairment)
Total serum testosterone level (TT) < 350 ng/dL and > 100 ng/dL
Without dementia (Mini-Mental State Examination [MMSE] score > 24)

Exclusion Criteria:

Use of testosterone, anabolic steroids, dehydroepiandrosterone (DHEA), androstenedione or recombinant growth hormone (rGH) in the past year
Alcohol or drug abuse
Use of anti-convulsants or glucocorticoids (equivalent to prednisone > 20 mg/day)
Prostate cancer, breast cancer or other cancers with life expectancy < 5 years
Limiting neuromuscular, joint or bone disease, or history of stroke with residual neurological problems
Any neurological condition that would impact cognitive functioning including:
- epilepsy
- multiple sclerosis
- HIV
- Parkinson's disease
- stroke
- other focal lesion
Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) Axis I psychiatric disorder in past year or use of psychotropic medications in 6 months
Abnormal prostate examination; PSA > 4 ng/mL; or BPH symptom score > 21
Unstable angina, New York (NY) class III or IV congestive heart failure or myocardial infarction within 3 months of entry
Abnormal laboratory values (at discretion of principal investigator)
Untreated thyroid disease; systolic blood pressure > 160 or diastolic > 100 mm Hg
Body mass index > 40 kg/m2
Untreated severe obstructive sleep apnea

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00240981

Locations

United States, Massachusetts
Boston University Medical Center
Boston, Massachusetts, United States, 02118
VA Boston Healthcare System (Jamaica Plain Campus)
Boston, Massachusetts, United States, 02130

Sponsors and Collaborators

Boston Medical Center

National Institute on Aging (NIA)

Investigators

Principal Investigator:	Shalender Bhasin, MD	Boston University Medical Center, Section of Endocrinology, Diabetes, and Nutrition
Study Director:	Shehzad Basaria, MD	Boston University Medical Center, Section of Endocrinology, Diabetes, and Nutrition
Principal Investigator:	Wildon Farwell, MD, MPH	VA Boston Healthcare System (Jamaica Plain Campus)

More Information

Publications:

Hughes VA, Frontera WR, Roubenoff R, Evans WJ, Singh MA. Longitudinal changes in body composition in older men and women: role of body weight change and physical activity. Am J Clin Nutr. 2002 Aug;76(2):473-81.

Hughes VA, Frontera WR, Wood M, Evans WJ, Dallal GE, Roubenoff R, Fiatarone Singh MA. Longitudinal muscle strength changes in older adults: influence of muscle mass, physical activity, and health. J Gerontol A Biol Sci Med Sci. 2001 May;56(5):B209-17.

Harman SM, Metter EJ, Tobin JD, Pearson J, Blackman MR; Baltimore Longitudinal Study of Aging. Longitudinal effects of aging on serum total and free testosterone levels in healthy men. Baltimore Longitudinal Study of Aging. J Clin Endocrinol Metab. 2001 Feb;86(2):724-31.

Gray A, Berlin JA, McKinlay JB, Longcope C. An examination of research design effects on the association of testosterone and male aging: results of a meta-analysis. J Clin Epidemiol. 1991;44(7):671-84.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Travison TG, Basaria S, Storer TW, Jette AM, Miciek R, Farwell WR, Choong K, Lakshman K, Mazer NA, Coviello AD, Knapp PE, Ulloor J, Zhang A, Brooks B, Nguyen AH, Eder R, LeBrasseur N, Elmi A, Appleman E, Hede-Brierley L, Bhasin G, Bhatia A, Lazzari A, Davis S, Ni P, Collins L, Bhasin S. Clinical meaningfulness of the changes in muscle performance and physical function associated with testosterone administration in older men with mobility limitation. J Gerontol A Biol Sci Med Sci. 2011 Oct;66(10):1090-9. Epub 2011 Jun 22.

Basaria S, Coviello AD, Travison TG, Storer TW, Farwell WR, Jette AM, Eder R, Tennstedt S, Ulloor J, Zhang A, Choong K, Lakshman KM, Mazer NA, Miciek R, Krasnoff J, Elmi A, Knapp PE, Brooks B, Appleman E, Aggarwal S, Bhasin G, Hede-Brierley L, Bhatia A, Collins L, LeBrasseur N, Fiore LD, Bhasin S. Adverse events associated with testosterone administration. N Engl J Med. 2010 Jul 8;363(2):109-22. Epub 2010 Jun 30.

LeBrasseur NK, Lajevardi N, Miciek R, Mazer N, Storer TW, Bhasin S. Effects of testosterone therapy on muscle performance and physical function in older men with mobility limitations (The TOM Trial): design and methods. Contemp Clin Trials. 2009 Mar;30(2):133-40. Epub 2008 Oct 29.

Responsible Party:	Shalender Bhasin, MD, Principal Investigator, Boston University Medical Center
ClinicalTrials.gov Identifier:	NCT00240981 History of Changes
Other Study ID Numbers:	AG0057, U01AG014369, 2U01AG14369-06
Study First Received:	October 14, 2005
Last Updated:	April 2, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Boston Medical Center:

Andropause
frailty
hormone replacement therapy
Aging

Additional relevant MeSH terms:

Hypogonadism
Muscular Diseases
Sarcopenia
Gonadal Disorders
Endocrine System Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Atrophy
Pathological Conditions, Anatomical
Signs and Symptoms

Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents

ClinicalTrials.gov processed this record on February 12, 2012