Trial Outcomes & Findings for TOM: Testosterone in Older Men With Sarcopenia (NCT NCT00240981)

NCT ID: NCT00240981

Last Updated: 2017-02-23

Results Overview

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

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 209 participants
• Primary outcome timeframe: baseline and 6 months
• Results posted on: 2017-02-23

Participant Flow

All participants provided written, informed consent. Recruitment took place at VAHCS, NERI, and BUMC. Outcome assessments were performed at BUMC. The study consisted of a 24- week intervention followed by a 12-week observation period. Enrollment took place between September 2005 and December 2009.

The participants were community-dwelling men, aged 65 years and older, with total testosterone between 100 and 350 ng/dL or free testosterone less than 50 pg/mL, and mobility limitation.

Participant milestones

Measure	Treatment	Placebo
Overall Study STARTED	106	103
Overall Study Intent to Treat Sample	82	83
Overall Study COMPLETED	68	70
Overall Study NOT COMPLETED	38	33

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

TOM: Testosterone in Older Men With Sarcopenia

Baseline characteristics by cohort

Measure	Treatment n=106 Participants 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.	Placebo n=103 Participants Topical gel (placebo formulation): Starting dose 15 g/day (3 tubes), applied to upper arms and shoulders each day.	Total n=209 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical >=65 years	106 Participants n=93 Participants	103 Participants n=4 Participants	209 Participants n=27 Participants
Age, Continuous	74 Years STANDARD_DEVIATION 6 • n=93 Participants	74 Years STANDARD_DEVIATION 5 • n=4 Participants	74 Years STANDARD_DEVIATION 5.4 • n=27 Participants
Sex: Female, Male Female	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Sex: Female, Male Male	106 Participants n=93 Participants	103 Participants n=4 Participants	209 Participants n=27 Participants
Region of Enrollment United States	106 participants n=93 Participants	103 participants n=4 Participants	209 participants n=27 Participants

PRIMARY outcome

Timeframe: baseline and 6 months

Population: Participants with baseline and at least one post baseline measure.

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

Outcome measures

Measure	Treatment n=49 Participants 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.	Placebo n=54 Participants 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	156.9 Newtons Interval 89.2 to 224.6	27.1 Newtons Interval -28.3 to 82.6

SECONDARY outcome

Timeframe: baseline and 6 months

Population: Participants with baseline and 1 post baseline measure.

Change from baseline in chest press strength at 6 months

Outcome measures

Measure	Treatment n=38 Participants 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.	Placebo n=44 Participants Topical gel (placebo formulation): Starting dose 15 g/day (3 tubes), applied to upper arms and shoulders each day.
Chest-Press	34.7 Newtons Interval 18.7 to 51.4	0.28 Newtons Interval -13.8 to 14.3

SECONDARY outcome

Timeframe: baseline and 6 month

Population: Participants with baseline and one post baseline measure.

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

Outcome measures

Measure	Treatment n=49 Participants 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.	Placebo n=52 Participants Topical gel (placebo formulation): Starting dose 15 g/day (3 tubes), applied to upper arms and shoulders each day.
Stair-climbing Test (Without a Load)	19.5 Watts Interval 7.4 to 31.5	10.7 Watts Interval -2.9 to 24.3

SECONDARY outcome

Timeframe: baseline and 6 months

Population: The participants with baseline and one post baseline measure are included.

Change from baseline in grip strength in the dominant hand.

Outcome measures

Measure	Treatment n=63 Participants 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.	Placebo n=70 Participants Topical gel (placebo formulation): Starting dose 15 g/day (3 tubes), applied to upper arms and shoulders each day.
Grip Strength	1.0 Kilograms Interval -0.1 to 2.0	0.7 Kilograms Interval -0.3 to 1.7

SECONDARY outcome

Timeframe: baseline and 6 months

Population: Participants with a baseline and one post baseline measure.

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

Outcome measures

Measure	Treatment n=39 Participants 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.	Placebo n=43 Participants Topical gel (placebo formulation): Starting dose 15 g/day (3 tubes), applied to upper arms and shoulders each day.
50-Meter Walking Speed (Without a Load)	0.074 meters/second Interval -0.004 to 0.153	0.024 meters/second Interval -0.018 to 0.066

SECONDARY outcome

Timeframe: baseline and 6 months

Population: Participants with one baseline and one post baseline measure.

Change from baseline in Stair-climbing Test (loaded)

Outcome measures

Measure	Treatment n=46 Participants 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.	Placebo n=50 Participants Topical gel (placebo formulation): Starting dose 15 g/day (3 tubes), applied to upper arms and shoulders each day.
Stair-climbing Test (Loaded)	39.2 Watts Interval 14.4 to 64.0	9.0 Watts Interval -8.4 to 26.4

SECONDARY outcome

Timeframe: baseline and 6 months

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

Outcome measures

Measure	Treatment n=56 Participants 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.	Placebo n=55 Participants Topical gel (placebo formulation): Starting dose 15 g/day (3 tubes), applied to upper arms and shoulders each day.
Late Life Functional Disability Index (LLFDI)	61.2 units on a scale Interval 38.0 to 100.0	61.7 units on a scale Interval 38.0 to 100.0

SECONDARY outcome

Timeframe: baseline, 3 months, and 6 months

Outcome measures

Measure	Treatment n=82 Participants 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.	Placebo n=81 Participants Topical gel (placebo formulation): Starting dose 15 g/day (3 tubes), applied to upper arms and shoulders each day.
Total Lean Mass Baseline	55.1 Kilograms Standard Deviation 6.9	56.5 Kilograms Standard Deviation 6.5
Total Lean Mass 3 Months (N=73,75)	57.2 Kilograms Standard Deviation 7.1	56.7 Kilograms Standard Deviation 6.2
Total Lean Mass 6 Months (N=77,80)	56.1 Kilograms Standard Deviation 6.9	56.2 Kilograms Standard Deviation 6.3

SECONDARY outcome

Timeframe: baseline, 3 months, and 6 months

Outcome measures

Measure	Treatment n=82 Participants 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.	Placebo n=81 Participants Topical gel (placebo formulation): Starting dose 15 g/day (3 tubes), applied to upper arms and shoulders each day.
Total Fat Mass Baseline (N=82,81)	26.2 Kilograms Standard Deviation 7.5	28 Kilograms Standard Deviation 8.4
Total Fat Mass 3 Months (N=73,75)	24.9 Kilograms Standard Deviation 7.1	28 Kilograms Standard Deviation 8.1
Total Fat Mass 6 Months (N=77,80)	24.0 Kilograms Standard Deviation 6.8	27.5 Kilograms Standard Deviation 7.9

SECONDARY outcome

Timeframe: baseline and 6 months

Population: Participants with a baseline and one post baseline measure.

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

Outcome measures

Measure	Treatment n=26 Participants 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.	Placebo n=29 Participants Topical gel (placebo formulation): Starting dose 15 g/day (3 tubes), applied to upper arms and shoulders each day.
50-Meter Walking Speed (With a Load)	0.139 meters/second Interval 0.023 to 0.256	0.065 meters/second Interval 0.013 to 0.116

Adverse Events

Treatment

Serious events: 16 serious events

Other events: 35 other events

Deaths: 0 deaths

Placebo

Serious events: 8 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Measure	Treatment n=106 participants at risk 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.	Placebo n=103 participants at risk Topical gel (placebo formulation): Starting dose 15 g/day (3 tubes), applied to upper arms and shoulders each day.
Cardiac disorders Acute coronary syndrome	0.94% 1/106 • Number of events 1 • Adverse event data were collected throughout the entire study period (4 years and 3 months)	0.00% 0/103 • Adverse event data were collected throughout the entire study period (4 years and 3 months)
Metabolism and nutrition disorders Diabetic foot ulcer	0.94% 1/106 • Number of events 1 • Adverse event data were collected throughout the entire study period (4 years and 3 months)	0.00% 0/103 • Adverse event data were collected throughout the entire study period (4 years and 3 months)
Investigations Prostate cancer	0.94% 1/106 • Number of events 1 • Adverse event data were collected throughout the entire study period (4 years and 3 months)	0.00% 0/103 • Adverse event data were collected throughout the entire study period (4 years and 3 months)
Infections and infestations Cholecystitis	0.94% 1/106 • Number of events 1 • Adverse event data were collected throughout the entire study period (4 years and 3 months)	0.00% 0/103 • Adverse event data were collected throughout the entire study period (4 years and 3 months)
Cardiac disorders Myocardial infarction treated with angioplasty, pacemaker placement	0.94% 1/106 • Number of events 1 • Adverse event data were collected throughout the entire study period (4 years and 3 months)	0.00% 0/103 • Adverse event data were collected throughout the entire study period (4 years and 3 months)
Cardiac disorders Myocardial infarction	0.94% 1/106 • Number of events 1 • Adverse event data were collected throughout the entire study period (4 years and 3 months)	0.00% 0/103 • Adverse event data were collected throughout the entire study period (4 years and 3 months)
Cardiac disorders Panic attack	0.94% 1/106 • Number of events 1 • Adverse event data were collected throughout the entire study period (4 years and 3 months)	0.00% 0/103 • Adverse event data were collected throughout the entire study period (4 years and 3 months)
Infections and infestations Appendicitis	0.94% 1/106 • Number of events 1 • Adverse event data were collected throughout the entire study period (4 years and 3 months)	0.00% 0/103 • Adverse event data were collected throughout the entire study period (4 years and 3 months)
Surgical and medical procedures Angioplasty and coronary artery bypass grafting	0.94% 1/106 • Number of events 1 • Adverse event data were collected throughout the entire study period (4 years and 3 months)	0.00% 0/103 • Adverse event data were collected throughout the entire study period (4 years and 3 months)
Cardiac disorders Congestive heart failure	0.94% 1/106 • Number of events 1 • Adverse event data were collected throughout the entire study period (4 years and 3 months)	0.00% 0/103 • Adverse event data were collected throughout the entire study period (4 years and 3 months)
Injury, poisoning and procedural complications Fracture of the tibia	0.94% 1/106 • Number of events 1 • Adverse event data were collected throughout the entire study period (4 years and 3 months)	0.00% 0/103 • Adverse event data were collected throughout the entire study period (4 years and 3 months)
Nervous system disorders Stroke	0.94% 1/106 • Number of events 1 • Adverse event data were collected throughout the entire study period (4 years and 3 months)	0.00% 0/103 • Adverse event data were collected throughout the entire study period (4 years and 3 months)
Cardiac disorders Death, suspected myocardial infarction	0.94% 1/106 • Number of events 1 • Adverse event data were collected throughout the entire study period (4 years and 3 months)	0.00% 0/103 • Adverse event data were collected throughout the entire study period (4 years and 3 months)
Nervous system disorders Bupropion toxicity	0.94% 1/106 • Number of events 1 • Adverse event data were collected throughout the entire study period (4 years and 3 months)	0.00% 0/103 • Adverse event data were collected throughout the entire study period (4 years and 3 months)
Surgical and medical procedures Peripheral angioplasty and stenting	0.94% 1/106 • Number of events 1 • Adverse event data were collected throughout the entire study period (4 years and 3 months)	0.00% 0/103 • Adverse event data were collected throughout the entire study period (4 years and 3 months)
Injury, poisoning and procedural complications Clozapine toxicity	0.94% 1/106 • Number of events 1 • Adverse event data were collected throughout the entire study period (4 years and 3 months)	0.00% 0/103 • Adverse event data were collected throughout the entire study period (4 years and 3 months)
Cardiac disorders Congestive heart failure exacerbation	0.94% 1/106 • Number of events 1 • Adverse event data were collected throughout the entire study period (4 years and 3 months)	0.00% 0/103 • Adverse event data were collected throughout the entire study period (4 years and 3 months)
Infections and infestations Community acquired pneumonia	0.94% 1/106 • Number of events 1 • Adverse event data were collected throughout the entire study period (4 years and 3 months)	0.97% 1/103 • Number of events 1 • Adverse event data were collected throughout the entire study period (4 years and 3 months)
Nervous system disorders Syncope resulting in hospitalization	0.00% 0/106 • Adverse event data were collected throughout the entire study period (4 years and 3 months)	0.97% 1/103 • Number of events 1 • Adverse event data were collected throughout the entire study period (4 years and 3 months)
Nervous system disorders Painful neuropathy	0.00% 0/106 • Adverse event data were collected throughout the entire study period (4 years and 3 months)	0.97% 1/103 • Number of events 1 • Adverse event data were collected throughout the entire study period (4 years and 3 months)
Hepatobiliary disorders Hepatocellular carcinoma	0.00% 0/106 • Adverse event data were collected throughout the entire study period (4 years and 3 months)	0.97% 1/103 • Number of events 1 • Adverse event data were collected throughout the entire study period (4 years and 3 months)
Gastrointestinal disorders Intestinal obstruction	0.00% 0/106 • Adverse event data were collected throughout the entire study period (4 years and 3 months)	0.97% 1/103 • Number of events 1 • Adverse event data were collected throughout the entire study period (4 years and 3 months)
Surgical and medical procedures Transurethral resection of prostate	0.00% 0/106 • Adverse event data were collected throughout the entire study period (4 years and 3 months)	0.97% 1/103 • Number of events 1 • Adverse event data were collected throughout the entire study period (4 years and 3 months)
Gastrointestinal disorders Abdominal pain	0.00% 0/106 • Adverse event data were collected throughout the entire study period (4 years and 3 months)	0.97% 1/103 • Number of events 1 • Adverse event data were collected throughout the entire study period (4 years and 3 months)
Injury, poisoning and procedural complications Splenic rupture	0.00% 0/106 • Adverse event data were collected throughout the entire study period (4 years and 3 months)	0.97% 1/103 • Number of events 1 • Adverse event data were collected throughout the entire study period (4 years and 3 months)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Inflammatory colonic mass related to Crohn's Disease	0.00% 0/106 • Adverse event data were collected throughout the entire study period (4 years and 3 months)	0.97% 1/103 • Number of events 1 • Adverse event data were collected throughout the entire study period (4 years and 3 months)
Gastrointestinal disorders Rectal bleeding from Crohn's Disease	0.00% 0/106 • Adverse event data were collected throughout the entire study period (4 years and 3 months)	0.97% 1/103 • Number of events 1 • Adverse event data were collected throughout the entire study period (4 years and 3 months)

Other adverse events

Measure	Treatment n=106 participants at risk 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.	Placebo n=103 participants at risk Topical gel (placebo formulation): Starting dose 15 g/day (3 tubes), applied to upper arms and shoulders each day.
General disorders General disorders and administration site conditions	4.7% 5/106 • Number of events 5 • Adverse event data were collected throughout the entire study period (4 years and 3 months)	0.00% 0/103 • Adverse event data were collected throughout the entire study period (4 years and 3 months)
Infections and infestations Infections and infestations	4.7% 5/106 • Number of events 5 • Adverse event data were collected throughout the entire study period (4 years and 3 months)	3.9% 4/103 • Number of events 4 • Adverse event data were collected throughout the entire study period (4 years and 3 months)
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorders	10.4% 11/106 • Number of events 11 • Adverse event data were collected throughout the entire study period (4 years and 3 months)	5.8% 6/103 • Number of events 6 • Adverse event data were collected throughout the entire study period (4 years and 3 months)
Reproductive system and breast disorders Reproductive system and breast disorders	4.7% 5/106 • Number of events 5 • Adverse event data were collected throughout the entire study period (4 years and 3 months)	0.00% 0/103 • Adverse event data were collected throughout the entire study period (4 years and 3 months)
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders	8.5% 9/106 • Number of events 9 • Adverse event data were collected throughout the entire study period (4 years and 3 months)	0.00% 0/103 • Adverse event data were collected throughout the entire study period (4 years and 3 months)

Additional Information

Dr. Shalender Bhasin

Brigham & Women's Hospital

Phone: 617-525-9150

Email: sbhasin@partners.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place