Clinical trial NCT00190060: Study of The Effects of Testosterone in Frail Elderly Men
Official title: Study of The Effects of Testosterone on Muscle Function, Physical Performance, Body Composition and Quality of Life in Frail Elderly Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Frailty
Sarcopenia
Keywords: Frailty
Muscle strength
Physical performance
Bone mineral density
Quality of life
Lead sponsor: Manchester University NHS Foundation Trust
Sponsor class: OTHER_GOV
Collaborators: name: University of Manchester
name: Bayer
First posted: 2005-09-19
Enrollment: 262
Sex: MALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

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

Primary outcomes:
measure: Lower limb muscle strength at 6 months
timeFrame: 6 months
Secondary outcomes:
measure: Upper limb muscle strength at 6 months
timeFrame: 6 months
measure: Quality of life at 6 months
timeFrame: 6 months
measure: Total and regional lean body mass at 6 months
timeFrame: 6 months
measure: Improvement in physical performance
timeFrame: 6 months
measure: Bone Mineral Density
timeFrame: 6 months
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Wellcome Trust Clinical Research Facility, Manchester Royal Infirmary
Study officials:
affiliation: Central Manchester and Manchester Children's University Hospitals Trust & The University of Manchester
name: Professor Frederick CW Wu, MD, FRCP
role: PRINCIPAL_INVESTIGATOR
affiliation: Central Manchester and Manchester Children's University Hospitals Trust
name: Dr Martin Connolly, MD, FRCP
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Manchester
name: Professor JA Oldham, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1093/gerona/56.3.m146.
citation: 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. doi: 10.1210/jcem-59-5-955.
citation: 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. doi: 10.1046/j.1365-2605.1999.00177.x.
citation: 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. doi: 10.1152/ajpendo.2001.281.6.E1172.
citation: O'Connell MD, Roberts SA, Srinivas-Shankar U, Tajar A, Connolly MJ, Adams JE, Oldham JA, Wu FC. Do the effects of testosterone on muscle strength, physical function, body composition, and quality of life persist six months after treatment in intermediate-frail and frail elderly men? J Clin Endocrinol Metab. 2011 Feb;96(2):454-8. doi: 10.1210/jc.2010-1167. Epub 2010 Nov 17.