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临床试验/NCT00190060
NCT00190060已完成4 期

Study of The Effects of Testosterone on Muscle Function, Physical Performance, Body Composition and Quality of Life in Frail Elderly Men

Manchester University NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 262 人开始时间: 2004年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
262
试验地点
1
主要终点
Lower limb muscle strength at 6 months

研究概览

简要总结

The study aims to determine the effects of testosterone on muscle function, mobility, activities of daily living and overall quality of life

详细描述

Ageing-associated loss of muscle mass and strength is a major cause of physical frailty, disability, morbidity and dependency in the elderly. This is associated with increased falls, fractures, loss of mobility, restricted activities of daily living and increased utilisation of healthcare resources. It is well known that serum testosterone levels fall with advancing age and this may be an important cause for muscle wasting and weakness (sarcopenia). Testosterone replacement increases muscle mass and improves muscle strength in young hypogonadal men. In relatively healthy elderly men, some short-term studies have also shown that testosterone can improve muscle strength. The potential beneficial effects of testosterone supplementation on muscle strength and functional capacity of frail elderly men has so far not been studies and forms the basis of this research. We hypothesise that testosterone supplementation is an effective, safe and economic anabolic intervention in frail elderly men with low circulating testosterone.

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
Quadruple (Participant, Care Provider, 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

入选标准

  • Frail elderly men (as defined by Freid's criteria of frailty)
  • Community - dwelling men aged 65 years and above
  • Total testosterone ≤12.0 nmol/L or calculated free T≤0.25nmol/L

排除标准

  • Carcinoma of prostate
  • Carcinoma of breast
  • PSA >4ng/mL
  • Severe symptomatic benign prostatic hypertrophy (IPSS >21)
  • Active liver disease
  • Renal impairment (serum creatinine >180 mmol/L)
  • Congestive heart failure
  • Unstable ischaemic heart disease
  • Polycythaemia
  • Evidence of systemic disease which may affect muscle/joint function
  • Moderate to severe peripheral vascular disease
  • Moderate to severe chronic obstructive airways disease
  • Alcohol consumption over 30 units per week
  • Medications that interfere with sex steroid metabolism
  • History of stroke causing persistent motor deficit
  • Cognitive deficit
  • Major psychiatric illness
  • Hospital admission in the past 6 weeks
  • Sleep apnoea

研究组 & 干预措施

1

Active Comparator

Transdermal testosterone gel (Testogel 1% )

干预措施: Transdermal testosterone gel (Testogel 1% ) (Drug)

2

Placebo Comparator

Matched transdermal placebo gel

干预措施: Matched transdermal placebo gel (Drug)

结局指标

主要结局

Lower limb muscle strength at 6 months

时间窗: 6 months

次要结局

  • Upper limb muscle strength at 6 months(6 months)
  • Improvement in physical performance(6 months)
  • Bone Mineral Density(6 months)
  • Quality of life at 6 months(6 months)
  • Total and regional lean body mass at 6 months(6 months)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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