TOM: Testosterone in Older Men With Sarcopenia

NCT00240981 | Terminated Phase 4 Results DMC

• 2 other identifiers: AG0057U01AG014369
• Study Type: interventional
• Target: 209
• Locations: 1 country
• Sites: 2

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.

Conditions

Sarcopenia; Hypogonadism; Muscular Diseases

Keywords

Andropause; frailty; hormone replacement therapy; Aging

Outcome Measures

Primary Outcomes (1)

• Changes in Physical Performance Measured by an Exercise Testing Regimen

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

  baseline and 6 months

Secondary Outcomes (9)

• Chest-Press

  baseline and 6 months

• Stair-climbing Test (Without a Load)

  baseline and 6 month

• Grip Strength

  baseline and 6 months

• 50-Meter Walking Speed (Without a Load)

  baseline and 6 months

• Stair-climbing Test (Loaded)

  baseline and 6 months

Study Arms (2)

Treatment

EXPERIMENTAL

Drug: Topical testosterone gel 1% (active formulation)

Placebo

PLACEBO COMPARATOR

Drug: Topical gel (placebo formulation)

Interventions

Topical testosterone gel 1% (active formulation) DRUG

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.

Also known as: Testim®

Treatment

Topical gel (placebo formulation) DRUG

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

Placebo

Eligibility Criteria

• Age: 65 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Medical Center: lead
• National Institute on Aging (NIA): collaborator

Study Sites (2)

Boston University Medical Center

Boston, Massachusetts, 02118, United States

Location

VA Boston Healthcare System (Jamaica Plain Campus)

Boston, Massachusetts, 02130, United States

Location

Related Publications (12)

• 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.

  PMID: 12145025 BACKGROUND

• 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.

  PMID: 11320101 BACKGROUND

• 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.

  PMID: 11158037 BACKGROUND

• 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.

  PMID: 1829756 BACKGROUND

• 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.

  PMID: 20592293 RESULT

• Lee H, Hwang EC, Oh CK, Lee S, Yu HS, Lim JS, Kim HW, Walsh T, Kim MH, Jung JH, Dahm P. Testosterone replacement in men with sexual dysfunction. Cochrane Database Syst Rev. 2024 Jan 15;1(1):CD013071. doi: 10.1002/14651858.CD013071.pub2.

  PMID: 38224135 DERIVED

• 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.

  PMID: 29846604 DERIVED

• 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.

  PMID: 28981994 DERIVED

• 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.

  PMID: 28950424 DERIVED

• 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.

  PMID: 23292288 DERIVED

• 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.

  PMID: 21697501 DERIVED

• 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.

  PMID: 18996225 DERIVED

MeSH Terms

Conditions

Sarcopenia; Hypogonadism; Muscular Diseases; Frailty

Interventions

Testosterone; Gels

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Gonadal Disorders; Endocrine System Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Pathologic Processes

Intervention Hierarchy (Ancestors)

Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Results Point of Contact

• Title: Dr. Shalender Bhasin
• Organization: Brigham & Women's Hospital

sbhasin@partners.org

617-525-9150

Study Officials

• Shalender Bhasin, MD

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

  PRINCIPAL INVESTIGATOR

• Shehzad Basaria, MD

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

  STUDY DIRECTOR

• Wildon Farwell, MD, MPH

  VA Boston Healthcare System (Jamaica Plain Campus)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: October 14, 2005
• First Posted: October 18, 2005
• Study Start: January 1, 2005
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: February 23, 2017
• Results First Posted: February 23, 2017

Record last verified: 2017-02

Locations

US (2)