Study of The Effects of Testosterone in Frail Elderly Men

Launched by MANCHESTER UNIVERSITY NHS FOUNDATION TRUST · Sep 11, 2005

Keywords

ClinConnect Summary

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 s...

Gender

MALE

Eligibility criteria

• 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