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Status:

TERMINATED

TOM: Testosterone in Older Men With Sarcopenia

Lead Sponsor:

Boston Medical Center

Collaborating Sponsors:

National Institute on Aging (NIA)

Conditions:

Sarcopenia

Hypogonadism

Eligibility:

MALE

65+ years

Phase:

PHASE4

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 we...

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 maxima...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

January 1 2005

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 1 2009

Estimated Enrollment :

209 Patients enrolled

Trial Details

Trial ID

NCT00240981

Start Date

January 1 2005

End Date

December 1 2009

Last Update

February 23 2017

Active Locations (2)

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Page 1 of 1 (2 locations)

1

Boston University Medical Center

Boston, Massachusetts, United States, 02118

2

VA Boston Healthcare System (Jamaica Plain Campus)

Boston, Massachusetts, United States, 02130