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TOM: Testosterone in Older Men With Sarcopenia

This study has been terminated.
(Higher incidence of cardiovascular events in the testosterone arm of the trial. Decision taken by the DSMB on December 31st, 2009.)
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Shalender Bhasin, Boston Medical Center
ClinicalTrials.gov Identifier:
NCT00240981
First received: October 14, 2005
Last updated: February 22, 2017
Last verified: February 2017
October 14, 2005
February 22, 2017
January 2005
December 2009   (Final data collection date for primary outcome measure)
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.
Changes in physical performance measured by an exercise testing regimen at baseline, 3 months, and 6 months.
Complete list of historical versions of study NCT00240981 on ClinicalTrials.gov Archive Site
  • Chest-Press [ Time Frame: baseline and 6 months ]
    Change from baseline in chest press strength at 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.
  • Grip Strength [ Time Frame: baseline and 6 months ]
    Change from baseline in grip strength in the dominant hand.
  • 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
  • Stair-climbing Test (Loaded) [ Time Frame: baseline and 6 months ]
    Change from baseline in Stair-climbing Test (loaded)
  • 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
  • Total Lean Mass [ Time Frame: baseline, 3 months, and 6 months ]
  • Total Fat Mass [ Time Frame: 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
Changes in disability, fatigue, affect, and sense of well being assessed by validated questionnaires at baseline, 3 months, and 6 months.
Not Provided
Not Provided
 
TOM: Testosterone in Older Men With Sarcopenia
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.

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.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator, Outcomes Assessor
Primary Purpose: Treatment
  • Sarcopenia
  • Hypogonadism
  • Muscular Diseases
  • 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®
  • Drug: Topical gel (placebo formulation)
    Starting dose 15 g/day (3 tubes), applied to upper arms and shoulders each day.
  • Experimental: Treatment
    Intervention: Drug: Topical testosterone gel 1% (active formulation)
  • Placebo Comparator: Placebo
    Intervention: Drug: Topical gel (placebo formulation)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
209
December 2009
December 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
65 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00240981
AG0057
U01AG014369 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
Shalender Bhasin, Boston Medical Center
Boston Medical Center
National Institute on Aging (NIA)
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)
Boston Medical Center
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP