Testosterone Replacement for Older Men With Sarcopenia
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 209
- 试验地点
- 2
- 主要终点
- Changes in Physical Performance Measured by an Exercise Testing Regimen
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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:
- •multiple sclerosis
- •Parkinson's disease
- •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
研究组 & 干预措施
Treatment
干预措施: Topical testosterone gel 1% (active formulation) (Drug)
Placebo
干预措施: Topical gel (placebo formulation) (Drug)
结局指标
主要结局
Changes in Physical Performance Measured by an Exercise Testing Regimen
时间窗: baseline and 6 months
Primary outcome was a change from baseline in leg-press strength at 6 months.
次要结局
- 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)
- Late Life Functional Disability Index (LLFDI)(baseline and 6 months)
- Total Lean Mass(baseline, 3 months, and 6 months)
- Total Fat Mass(baseline, 3 months, and 6 months)
- 50-Meter Walking Speed (With a Load)(baseline and 6 months)
研究者
Shalender Bhasin
Professor of Medicine
Boston Medical Center