Study of The Effects of Testosterone in Frail Elderly Men

Condition(s) targeted: Frailty; Sarcopenia

Intervention: Transdermal testosterone gel (Testogel 1% ) (Drug); Matched transdermal placebo gel (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Central Manchester and Manchester Children's University hospitals NHS Trust

Official(s) and/or principal investigator(s):
Professor Frederick CW Wu, MD, FRCP, Principal Investigator, Affiliation: Central Manchester and Manchester Children's University Hospitals Trust & The University of Manchester
Dr Martin Connolly, MD, FRCP, Principal Investigator, Affiliation: Central Manchester and Manchester Children's University Hospitals Trust
Professor JA Oldham, PhD, Principal Investigator, Affiliation: The University of Manchester

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

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

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome: Lower limb muscle strength at 6 months

Secondary outcome:

Upper limb muscle strength at 6 months

Quality of life at 6 months

Total and regional lean body mass at 6 months

Improvement in physical performance

Bone Mineral Density

Detailed description: 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.

Minimum age: 65 Years. Maximum age: N/A. Gender(s): Male.

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

Wellcome Trust Clinical Research Facility, Manchester Royal Infirmary, Manchester M13 9WL, United Kingdom

Related publications:

Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56.

Deslypere JP, Vermeulen A. Leydig cell function in normal men: effect of age, life-style, residence, diet, and activity. J Clin Endocrinol Metab. 1984 Nov;59(5):955-62.

Clague JE, Wu FC, Horan MA. Difficulties in measuring the effect of testosterone replacement therapy on muscle function in older men. Int J Androl. 1999 Aug;22(4):261-5.

Bhasin S, Woodhouse L, Casaburi R, Singh AB, Bhasin D, Berman N, Chen X, Yarasheski KE, Magliano L, Dzekov C, Dzekov J, Bross R, Phillips J, Sinha-Hikim I, Shen R, Storer TW. Testosterone dose-response relationships in healthy young men. Am J Physiol Endocrinol Metab. 2001 Dec;281(6):E1172-81.

Starting date: October 2004
Ending date: March 2007
Last updated: November 29, 2007