Back to results

TOM: Testosterone in Older Men With Sarcopenia

Primary Purpose

Sarcopenia, Hypogonadism, Muscular Diseases

Status

Terminated

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Topical testosterone gel 1% (active formulation)

Topical gel (placebo formulation)

About this trial

This is an interventional treatment trial for Sarcopenia focused on measuring Andropause, frailty, hormone replacement therapy, Aging

Eligibility Criteria

65 Years - undefined (Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

Boston University Medical Center
VA Boston Healthcare System (Jamaica Plain Campus)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Treatment

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Changes in Physical Performance Measured by an Exercise Testing Regimen

Primary outcome was a change from baseline in leg-press strength at 6 months.

Secondary Outcome Measures

Chest-Press

Change from baseline in chest press strength at 6 months

Stair-climbing Test (Without a Load)

Change from baseline in the stair-climbing test (without a load) at 6 months.

Grip Strength

Change from baseline in grip strength in the dominant hand.

50-Meter Walking Speed (Without a Load)

Change from baseline 50-Meter Walking Speed (without a load) at 6 months

Stair-climbing Test (Loaded)

Change from baseline in Stair-climbing Test (loaded)

Late Life Functional Disability Index (LLFDI)

Percent change from baseline in the late life functional disability index at 6 months

Total Lean Mass

Total Fat Mass

50-Meter Walking Speed (With a Load)

Change from baseline 50-Meter Walking Speed (with a load) at 6 months

Full Information

NCT ID

NCT00240981

First Posted

October 14, 2005

Last Updated

February 22, 2017

Sponsor

Boston Medical Center

Collaborators

National Institute on Aging (NIA)

1. Study Identification

Unique Protocol Identification Number

NCT00240981

Brief Title

TOM: Testosterone in Older Men With Sarcopenia

Official Title

Testosterone Replacement for Older Men With Sarcopenia

Study Type

Interventional

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Terminated

Why Stopped

Higher incidence of cardiovascular events in the testosterone arm of the trial. Decision taken by the DSMB on December 31st, 2009.

Study Start Date

January 2005 (undefined)

Primary Completion Date

December 2009 (Actual)

Study Completion Date

December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Boston Medical Center

Collaborators

National Institute on Aging (NIA)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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 well being, and reduce fatigue.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sarcopenia, Hypogonadism, Muscular Diseases

Keywords

Andropause, frailty, hormone replacement therapy, Aging

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

209 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Topical testosterone gel 1% (active formulation)

Other Intervention Name(s)

Testim®

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Topical gel (placebo formulation)

Intervention Description

Starting dose 15 g/day (3 tubes), applied to upper arms and shoulders each day.

Primary Outcome Measure Information:

Title

Changes in Physical Performance Measured by an Exercise Testing Regimen

Description

Primary outcome was a change from baseline in leg-press strength at 6 months.

Time Frame

baseline and 6 months

Secondary Outcome Measure Information:

Title

Chest-Press

Description

Change from baseline in chest press strength at 6 months

Time Frame

baseline and 6 months

Title

Stair-climbing Test (Without a Load)

Description

Change from baseline in the stair-climbing test (without a load) at 6 months.

Time Frame

baseline and 6 month

Title

Grip Strength

Description

Change from baseline in grip strength in the dominant hand.

Time Frame

baseline and 6 months

Title

50-Meter Walking Speed (Without a Load)

Description

Change from baseline 50-Meter Walking Speed (without a load) at 6 months

Time Frame

baseline and 6 months

Title

Stair-climbing Test (Loaded)

Description

Change from baseline in Stair-climbing Test (loaded)

Time Frame

baseline and 6 months

Title

Late Life Functional Disability Index (LLFDI)

Description

Percent change from baseline in the late life functional disability index at 6 months

Time Frame

baseline and 6 months

Title

Total Lean Mass

Time Frame

baseline, 3 months, and 6 months

Title

Total Fat Mass

Time Frame

baseline, 3 months, and 6 months

Title

50-Meter Walking Speed (With a Load)

Description

Change from baseline 50-Meter Walking Speed (with a load) at 6 months

Time Frame

baseline and 6 months

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shalender Bhasin, MD

Organizational Affiliation

Boston University Medical Center, Section of Endocrinology, Diabetes, and Nutrition

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Shehzad Basaria, MD

Organizational Affiliation

Boston University Medical Center, Section of Endocrinology, Diabetes, and Nutrition

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Wildon Farwell, MD, MPH

Organizational Affiliation

VA Boston Healthcare System (Jamaica Plain Campus)

Official's Role

Principal Investigator

Facility Information:

Facility Name

Boston University Medical Center

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02118

Country

United States

Facility Name

VA Boston Healthcare System (Jamaica Plain Campus)

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02130

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

12145025

Citation

Hughes VA, Frontera WR, Roubenoff R, Evans WJ, Singh MA. Longitudinal changes in body composition in older men and women: role of body weight change and physical activity. Am J Clin Nutr. 2002 Aug;76(2):473-81. doi: 10.1093/ajcn/76.2.473.

Results Reference

background

PubMed Identifier

11320101

Citation

Hughes VA, Frontera WR, Wood M, Evans WJ, Dallal GE, Roubenoff R, Fiatarone Singh MA. Longitudinal muscle strength changes in older adults: influence of muscle mass, physical activity, and health. J Gerontol A Biol Sci Med Sci. 2001 May;56(5):B209-17. doi: 10.1093/gerona/56.5.b209.

Results Reference

background

PubMed Identifier

11158037

Citation

Harman SM, Metter EJ, Tobin JD, Pearson J, Blackman MR; Baltimore Longitudinal Study of Aging. Longitudinal effects of aging on serum total and free testosterone levels in healthy men. Baltimore Longitudinal Study of Aging. J Clin Endocrinol Metab. 2001 Feb;86(2):724-31. doi: 10.1210/jcem.86.2.7219.

Results Reference

background

PubMed Identifier

1829756

Citation

Gray A, Berlin JA, McKinlay JB, Longcope C. An examination of research design effects on the association of testosterone and male aging: results of a meta-analysis. J Clin Epidemiol. 1991;44(7):671-84. doi: 10.1016/0895-4356(91)90028-8.

Results Reference

background

PubMed Identifier

20592293

Citation

Basaria S, Coviello AD, Travison TG, Storer TW, Farwell WR, Jette AM, Eder R, Tennstedt S, Ulloor J, Zhang A, Choong K, Lakshman KM, Mazer NA, Miciek R, Krasnoff J, Elmi A, Knapp PE, Brooks B, Appleman E, Aggarwal S, Bhasin G, Hede-Brierley L, Bhatia A, Collins L, LeBrasseur N, Fiore LD, Bhasin S. Adverse events associated with testosterone administration. N Engl J Med. 2010 Jul 8;363(2):109-22. doi: 10.1056/NEJMoa1000485. Epub 2010 Jun 30.

Results Reference

result

PubMed Identifier

29846604

Citation

Traustadottir T, Harman SM, Tsitouras P, Pencina KM, Li Z, Travison TG, Eder R, Miciek R, McKinnon J, Woodbury E, Basaria S, Bhasin S, Storer TW. Long-Term Testosterone Supplementation in Older Men Attenuates Age-Related Decline in Aerobic Capacity. J Clin Endocrinol Metab. 2018 Aug 1;103(8):2861-2869. doi: 10.1210/jc.2017-01902.

Results Reference

derived

PubMed Identifier

28981994

Citation

Bhasin S, Travison TG, O'Brien L, MacKrell J, Krishnan V, Ouyang H, Pencina K, Basaria S. Contributors to the substantial variation in on-treatment testosterone levels in men receiving transdermal testosterone gels in randomized trials. Andrology. 2018 Jan;6(1):151-157. doi: 10.1111/andr.12428. Epub 2017 Oct 5.

Results Reference

derived

PubMed Identifier

28950424

Citation

Gagliano-Juca T, Storer TW, Pencina KM, Travison TG, Li Z, Huang G, Hettwer S, Dahinden P, Bhasin S, Basaria S. Testosterone does not affect agrin cleavage in mobility-limited older men despite improvement in physical function. Andrology. 2018 Jan;6(1):29-36. doi: 10.1111/andr.12424. Epub 2017 Sep 26.

Results Reference

derived

PubMed Identifier

23292288

Citation

Huang G, Bhasin S, Tang ER, Aakil A, Anderson SW, Jara H, Davda M, Travison TG, Basaria S. Effect of testosterone administration on liver fat in older men with mobility limitation: results from a randomized controlled trial. J Gerontol A Biol Sci Med Sci. 2013 Aug;68(8):954-9. doi: 10.1093/gerona/gls259. Epub 2013 Jan 4.

Results Reference

derived

PubMed Identifier

21697501

Citation

Travison TG, Basaria S, Storer TW, Jette AM, Miciek R, Farwell WR, Choong K, Lakshman K, Mazer NA, Coviello AD, Knapp PE, Ulloor J, Zhang A, Brooks B, Nguyen AH, Eder R, LeBrasseur N, Elmi A, Appleman E, Hede-Brierley L, Bhasin G, Bhatia A, Lazzari A, Davis S, Ni P, Collins L, Bhasin S. Clinical meaningfulness of the changes in muscle performance and physical function associated with testosterone administration in older men with mobility limitation. J Gerontol A Biol Sci Med Sci. 2011 Oct;66(10):1090-9. doi: 10.1093/gerona/glr100. Epub 2011 Jun 22.

Results Reference

derived

PubMed Identifier

18996225

Citation

LeBrasseur NK, Lajevardi N, Miciek R, Mazer N, Storer TW, Bhasin S. Effects of testosterone therapy on muscle performance and physical function in older men with mobility limitations (The TOM Trial): design and methods. Contemp Clin Trials. 2009 Mar;30(2):133-40. doi: 10.1016/j.cct.2008.10.005. Epub 2008 Oct 29.

Results Reference

derived

Learn more about this trial

TOM: Testosterone in Older Men With Sarcopenia

We'll reach out to this number within 24 hrs