TOM: Testosterone in Older Men With Sarcopenia

Phase 4

Terminated

• Conditions: Sarcopenia; Hypogonadism; Muscular Diseases
• Interventions: Drug: Topical testosterone gel 1% (active formulation); Drug: Topical gel (placebo formulation)

• Registration Number: NCT00240981
• Lead Sponsor: Boston Medical Center

Brief 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.

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.

Study Timeline

• Study Start: 2005-01
• Study First Submitted: 2005-10-14
• Study First Submitted QC: 2005-10-14
• Study First Posted: 2005-10-18
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2017-02
• Results First Submitted: 2017-02-08
• Results First Submitted QC: 2017-02-22
• Last Update Submitted: 2017-02-22
• Results First Posted: 2017-02-23
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 209

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	Topical testosterone gel 1% (active formulation)	-
Placebo	Topical gel (placebo formulation)	-

Primary Outcome Measures

Name	Time	Method
Changes in Physical Performance Measured by an Exercise Testing Regimen	baseline and 6 months	Primary outcome was a change from baseline in leg-press strength at 6 months.

Secondary Outcome Measures

Name	Time	Method
Chest-Press	baseline and 6 months	Change from baseline in chest press strength at 6 months
Stair-climbing Test (Without a Load)	baseline and 6 month	Change from baseline in the stair-climbing test (without a load) at 6 months.
Grip Strength	baseline and 6 months	Change from baseline in grip strength in the dominant hand.
50-Meter Walking Speed (Without a Load)	baseline and 6 months	Change from baseline 50-Meter Walking Speed (without a load) at 6 months
Stair-climbing Test (Loaded)	baseline and 6 months	Change from baseline in Stair-climbing Test (loaded)
Late Life Functional Disability Index (LLFDI)	baseline and 6 months	Percent change from baseline in the late life functional disability index at 6 months
Total Lean Mass	baseline, 3 months, and 6 months
Total Fat Mass	baseline, 3 months, and 6 months
50-Meter Walking Speed (With a Load)	baseline and 6 months	Change from baseline 50-Meter Walking Speed (with a load) at 6 months

Trial Locations

Locations (2)

VA Boston Healthcare System (Jamaica Plain Campus); 🇺🇸 Boston, Massachusetts, United States

Boston University Medical Center; 🇺🇸 Boston, Massachusetts, United States