TOM: Testosterone in Older Men With Sarcopenia

February 22, 2017 updated by: Shalender Bhasin, Boston Medical Center

Testosterone Replacement for Older Men With Sarcopenia

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

209

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Topical gel (placebo formulation)
Starting dose 15 g/day (3 tubes), applied to upper arms and shoulders each day.
Experimental: Treatment
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 Names:
  • Testim®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Physical Performance Measured by an Exercise Testing Regimen
Time Frame: baseline and 6 months
Primary outcome was a change from baseline in leg-press strength at 6 months.
baseline and 6 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Medical Center

Collaborators

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)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

October 14, 2005

First Submitted That Met QC Criteria

October 14, 2005

First Posted (Estimate)

October 18, 2005

Study Record Updates

Last Update Posted (Actual)

February 23, 2017

Last Update Submitted That Met QC Criteria

February 22, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AG0057
  • U01AG014369 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe