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TOM: Testosterone in Older Men With Sarcopenia

This study is currently recruiting participants.
Verified by National Institute on Aging (NIA), September 2008

Sponsored by: National Institute on Aging (NIA)
Information provided by: National Institute on Aging (NIA)
ClinicalTrials.gov Identifier: NCT00240981
  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 IV

MedlinePlus related topics:   Muscle Disorders   

Drug Information available for:   Testosterone    Methyltestosterone    Oxymesterone    Testosterone enanthate    Testosterone Propionate    Testosterone undecanoate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:   Testosterone Replacement for Older Men With Sarcopenia

Further study details as provided by National Institute on Aging (NIA):

Primary Outcome Measures:
  • Changes in physical performance measured by an exercise testing regimen [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment:   210
Study Start Date:   January 2005
Estimated Study Completion Date:   December 2010
Estimated Primary Completion Date:   December 2010 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental 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.
2: Placebo Comparator 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
Genders 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

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

Contacts
Contact: Lindsay Cloutier     617-414-1887     Lindsay.Cloutier@bmc.org    

Locations
United States, Massachusetts
Boston University Medical Center     Recruiting
      Boston, Massachusetts, United States, 02118
      Contact: Lindsay Cloutier     617-414-1887     Lindsay.Cloutier@bmc.org    
      Principal Investigator: Shalender Bhasin, MD            
VA Boston Healthcare System (Jamaica Plain Campus)     Recruiting
      Boston, Massachusetts, United States, 02130
      Contact: Joyce Ambrosino     857-364-4697     joyce.ambrosino@va.gov    
      Principal Investigator: Wildon Farwell, MD, MPH            

Sponsors and Collaborators

Investigators
Principal Investigator:     Shalender Bhasin, MD     Boston University Medical Center, Section of Endocrinology, Diabetes, and Nutrition    
Study Director:     Norman Mazer, MD, PhD     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:

Responsible Party:   Boston University Medical Center ( Shalender Bhasin, MD, Principal Investigator )
Study ID Numbers:   AG0057, 2U01AG14369-06
First Received:   October 14, 2005
Last Updated:   September 3, 2008
ClinicalTrials.gov Identifier:   NCT00240981
Health Authority:   United States: Food and Drug Administration

Keywords provided by National Institute on Aging (NIA):
Andropause  
frailty  
hormone replacement therapy  
Aging  

Study placed in the following topic categories:
Testosterone
Hypogonadism
Muscular Diseases
Neuromuscular Diseases
Musculoskeletal Diseases
Gonadal Disorders
Endocrine System Diseases
Methyltestosterone
Endocrinopathy
Testosterone 17 beta-cypionate

Additional relevant MeSH terms:
Anabolic Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Nervous System Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones
Pharmacologic Actions
Androgens

ClinicalTrials.gov processed this record on November 30, 2008




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