Study of The Effects of Testosterone in Frail Elderly Men

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

Detailed Description
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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.

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

Conditions
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Frailty, Sarcopenia

Intervention / Treatment
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* Drug: Transdermal testosterone gel (Testogel 1% )
* Drug: Matched transdermal placebo gel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Transdermal testosterone gel (Testogel 1% ) | Drug: Transdermal testosterone gel (Testogel 1% )<br>* Transdermal testosterone gel (Testogel 1% ), 50 mg/d for 6 months<br>* Other names: Testogel 1%;|
| Placebo Comparator: 2<br>Matched transdermal placebo gel | Drug: Matched transdermal placebo gel<br>* Matched transdermal placebo gel, 50mg/d for 6 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lower limb muscle strength at 6 months |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Upper limb muscle strength at 6 months |  | 6 months | 
| Quality of life at 6 months |  | 6 months | 
| Total and regional lean body mass at 6 months |  | 6 months | 
| Improvement in physical performance |  | 6 months | 
| Bone Mineral Density |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Frailty, Muscle strength, Physical performance, Bone mineral density, Quality of life