Study of The Effects of Testosterone in Frail Elderly Men - Full Text View

Purpose

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

Condition	Intervention	Phase
Frailty Sarcopenia	Drug: Transdermal testosterone gel (Testogel 1% ) Drug: Matched transdermal placebo gel	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Study of The Effects of Testosterone on Muscle Function, Physical Performance, Body Composition and Quality of Life in Frail Elderly Men

Resource links provided by NLM:

MedlinePlus related topics: Bone Density Minerals

Drug Information available for: Testosterone propionate Methyltestosterone Testosterone cypionate Testosterone Testosterone enanthate

U.S. FDA Resources

Further study details as provided by Central Manchester University Hospitals NHS Foundation Trust:

Primary Outcome Measures:

Lower limb muscle strength at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Upper limb muscle strength at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Quality of life at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Total and regional lean body mass at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Improvement in physical performance [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Bone Mineral Density [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment:	262
Study Start Date:	October 2004
Study Completion Date:	March 2007

Arms	Assigned Interventions
Active Comparator: 1 Transdermal testosterone gel (Testogel 1% )	Drug: Transdermal testosterone gel (Testogel 1% ) Transdermal testosterone gel (Testogel 1% ), 50 mg/d for 6 months Other Name: Testogel 1%
Placebo Comparator: 2 Matched transdermal placebo gel	Drug: Matched transdermal placebo gel Matched transdermal placebo gel, 50mg/d for 6 months

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

Ages Eligible for Study:	65 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00190060

Locations

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

Sponsors and Collaborators

Central Manchester University Hospitals NHS Foundation Trust

University of Manchester

Bayer

Investigators

Principal Investigator:	Professor Frederick CW Wu, MD, FRCP	Central Manchester and Manchester Children's University Hospitals Trust & The University of Manchester
Principal Investigator:	Dr Martin Connolly, MD, FRCP	Central Manchester and Manchester Children's University Hospitals Trust
Principal Investigator:	Professor JA Oldham, PhD	The University of Manchester

More Information

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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Epub 2010 Nov 17.

Responsible Party:	Professor FCW Wu, Central Manchester and Manchester Children's University Hospitals NHS Trust
ClinicalTrials.gov Identifier:	NCT00190060 History of Changes
Other Study ID Numbers:	CMMCHUT PIN 9197, T0053/WTCRF
Study First Received:	September 11, 2005
Last Updated:	November 29, 2007
Health Authority:	United Kingdom: National Health Service

Keywords provided by Central Manchester University Hospitals NHS Foundation Trust:

Frailty
Muscle strength
Physical performance
Bone mineral density
Quality of life

Additional relevant MeSH terms:

Sarcopenia
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Signs and Symptoms
Testosterone
Testosterone enanthate
Testosterone undecanoate

Testosterone 17 beta-cypionate
Methyltestosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents

ClinicalTrials.gov processed this record on May 23, 2013