Study of The Effects of Testosterone in Frail Elderly Men

Sarcopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00190060
• Other study ID #: CMMCHUT PIN 9197
• Secondary ID: T0053/WTCRF
• Status: Completed
• Phase: Phase 4
• Start date: October 2004
• Est. completion date: December 31, 2008

Study information

• Verified date: August 2018
• Source: Manchester University NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 262
• Est. completion date: December 31, 2008
• Est. primary completion date: December 31, 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Frailty
• Sarcopenia

Intervention

Drug:
• Transdermal testosterone gel (Testogel 1% )
Transdermal testosterone gel (Testogel 1% ), 50 mg/d for 6 months
• Matched transdermal placebo gel
Matched transdermal placebo gel, 50mg/d for 6 months

Locations

Country	Name	City	State
United Kingdom	Wellcome Trust Clinical Research Facility, Manchester Royal Infirmary	Manchester

Sponsors (3)

Lead Sponsor	Collaborator
Manchester University NHS Foundation Trust	Bayer, University of Manchester

Country where clinical trial is conducted

United Kingdom, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lower limb muscle strength at 6 months		6 months
Secondary	Upper limb muscle strength at 6 months		6 months
Secondary	Quality of life at 6 months		6 months
Secondary	Total and regional lean body mass at 6 months		6 months
Secondary	Improvement in physical performance		6 months
Secondary	Bone Mineral Density		6 months