This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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
  Purpose
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.

Condition Intervention Phase
Sarcopenia Hypogonadism Muscular Diseases Drug: Topical testosterone gel 1% (active formulation) Drug: Topical gel (placebo formulation) Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Testosterone Replacement for Older Men With Sarcopenia

Resource links provided by NLM:


Further study details as provided by Shalender Bhasin, Boston Medical Center:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 209
Study Start Date: January 2005
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Testim®
Placebo Comparator: Placebo Drug: Topical gel (placebo formulation)
Starting dose 15 g/day (3 tubes), applied to upper arms and shoulders each day.

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.

  Eligibility

Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00240981

Locations
United States, Massachusetts
Boston University Medical Center
Boston, Massachusetts, United States, 02118
VA Boston Healthcare System (Jamaica Plain Campus)
Boston, Massachusetts, United States, 02130
Sponsors and Collaborators
Boston Medical Center
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)
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Shalender Bhasin, Professor of Medicine, Boston Medical Center
ClinicalTrials.gov Identifier: NCT00240981     History of Changes
Other Study ID Numbers: AG0057
U01AG014369 ( U.S. NIH Grant/Contract )
Study First Received: October 14, 2005
Results First Received: February 8, 2017
Last Updated: February 22, 2017

Keywords provided by Shalender Bhasin, Boston Medical Center:
Andropause
frailty
hormone replacement therapy
Aging

Additional relevant MeSH terms:
Hypogonadism
Sarcopenia
Muscular Diseases
Gonadal Disorders
Endocrine System Diseases
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Signs and Symptoms
Musculoskeletal Diseases
Neuromuscular Diseases
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents

ClinicalTrials.gov processed this record on September 21, 2017