TOM: Testosterone in Older Men With Sarcopenia
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|ClinicalTrials.gov Identifier: NCT00240981|
Recruitment Status : Terminated (Higher incidence of cardiovascular events in the testosterone arm of the trial. Decision taken by the DSMB on December 31st, 2009.)
First Posted : October 18, 2005
Results First Posted : February 23, 2017
Last Update Posted : February 23, 2017
|Condition or disease||Intervention/treatment||Phase|
|Sarcopenia Hypogonadism Muscular Diseases||Drug: Topical testosterone gel 1% (active formulation) Drug: Topical gel (placebo formulation)||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||209 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Testosterone Replacement for Older Men With Sarcopenia|
|Study Start Date :||January 2005|
|Actual Primary Completion Date :||December 2009|
|Actual Study Completion Date :||December 2009|
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.
- 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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00240981
|United States, Massachusetts|
|Boston University Medical Center|
|Boston, Massachusetts, United States, 02118|
|VA Boston Healthcare System (Jamaica Plain Campus)|
|Boston, Massachusetts, United States, 02130|
|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)|