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TOM: Testosterone in Older Men With Sarcopenia

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Shalender Bhasin, Boston Medical Center
ClinicalTrials.gov Identifier:
NCT00240981
First received: October 14, 2005
Last updated: November 20, 2012
Last verified: November 2012

October 14, 2005
November 20, 2012
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 ] [ Designated as safety issue: No ]
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
Changes in disability, fatigue, affect, and sense of well being assessed by validated questionnaires [ Time Frame: baseline, 3 months, and 6 months ] [ Designated as safety issue: No ]
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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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: 1
    Intervention: Drug: Topical testosterone gel 1% (active formulation)
  • Placebo Comparator: 2
    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.
 
Completed
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
Male
65 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00240981
AG0057, U01AG014369, 2U01AG14369-06
Yes
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
November 2012

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