TOM: Testosterone in Older Men With Sarcopenia

Sarcopenia Clinical Trial

Official title:

Testosterone Replacement for Older Men With Sarcopenia

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00240981
• Other study ID #: AG0057
• Secondary ID: U01AG014369
• Status: Terminated
• Phase: Phase 4
• First received: October 14, 2005
• Last updated: February 22, 2017
• Start date: January 2005
• Est. completion date: December 2009

Study information

• Verified date: February 2017
• Source: Boston Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 209
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypogonadism
• Muscular Diseases
• Sarcopenia

Intervention

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.
• Topical gel (placebo formulation)
Starting dose 15 g/day (3 tubes), applied to upper arms and shoulders each day.

Locations

Country	Name	City	State
United States	Boston University Medical Center	Boston	Massachusetts
United States	VA Boston Healthcare System (Jamaica Plain Campus)	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston Medical Center	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

References & Publications (5)

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, C — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Physical Performance Measured by an Exercise Testing Regimen	Primary outcome was a change from baseline in leg-press strength at 6 months.	baseline and 6 months
Secondary	Chest-Press	Change from baseline in chest press strength at 6 months	baseline and 6 months
Secondary	Stair-climbing Test (Without a Load)	Change from baseline in the stair-climbing test (without a load) at 6 months.	baseline and 6 month
Secondary	Grip Strength	Change from baseline in grip strength in the dominant hand.	baseline and 6 months
Secondary	50-Meter Walking Speed (Without a Load)	Change from baseline 50-Meter Walking Speed (without a load) at 6 months	baseline and 6 months
Secondary	Stair-climbing Test (Loaded)	Change from baseline in Stair-climbing Test (loaded)	baseline and 6 months
Secondary	Late Life Functional Disability Index (LLFDI)	Percent change from baseline in the late life functional disability index at 6 months	baseline and 6 months
Secondary	Total Lean Mass		baseline, 3 months, and 6 months
Secondary	Total Fat Mass		baseline, 3 months, and 6 months
Secondary	50-Meter Walking Speed (With a Load)	Change from baseline 50-Meter Walking Speed (with a load) at 6 months	baseline and 6 months