TOM: Testosterone in Older Men With Sarcopenia

Condition(s) targeted: Sarcopenia; Hypogonadism; Muscular Diseases

Intervention: Topical testosterone gel 1% (active formulation) (Drug); Topical gel (placebo formulation) (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: National Institute on Aging (NIA)

Official(s) and/or principal investigator(s):
Shalender Bhasin, MD, Principal Investigator, Affiliation: Boston University Medical Center, Section of Endocrinology, Diabetes, and Nutrition
Norman Mazer, MD, PhD, Study Director, Affiliation: Boston University Medical Center, Section of Endocrinology, Diabetes, and Nutrition
Wildon Farwell, MD, MPH, Principal Investigator, Affiliation: VA Boston Healthcare System (Jamaica Plain Campus)

Overall contact:
Lindsay Cloutier, Phone: 617-414-1887, Email: Lindsay.Cloutier@bmc.org

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.

Official title: Testosterone Replacement for Older Men With Sarcopenia

Study design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome: Changes in physical performance measured by an exercise testing regimen

Secondary outcome: Changes in disability, fatigue, affect, and sense of well being assessed by validated questionnaires

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.

Minimum age: 65 Years. Maximum age: N/A. Gender(s): Male.

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

Lindsay Cloutier, Phone: 617-414-1887, Email: Lindsay.Cloutier@bmc.org

Boston University Medical Center, Boston, Massachusetts 02118, United States; Recruiting
Lindsay Cloutier, Phone: 617-414-1887, Email: Lindsay.Cloutier@bmc.org
Shalender Bhasin, MD, Principal Investigator

VA Boston Healthcare System (Jamaica Plain Campus), Boston, Massachusetts 02130, United States; Recruiting
Joyce Ambrosino, Phone: 857-364-4697, Email: joyce.ambrosino@va.gov
Wildon Farwell, MD, MPH, Principal Investigator

Related 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.

Starting date: January 2005
Ending date: December 2010
Last updated: September 3, 2008