The Effects of Testosterone and Nutritional Supplementation in the Undernourished Elderly

• Status: Unknown status
• Trial end date: 2007-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine what effect treatment for one year with testosterone and a nutritional supplement, alone and combined, has on the adverse effects of under-nutrition in community-dwelling older men and women.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Adelaide
• Collaborator: Organon
• Treatments: Methyltestosterone; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

Criteria

Inclusion Criteria:

• Men and women aged 65 years or older who are under-nourished, as defined by a Mini Nutritional Assessment (MNA) score <24 AND 1 or more of the following: *a body mass index (BMI) of less than 22 kg/m2; *weight loss of > 7.5% in the 3 months before enrolling in the study

• Living independently in the community (not in a hospital, nursing home or hostel)

• Understand and sign informed consent document, able to communicate with the investigator, and understand and comply with the requirements of the study.

• Women who are taking oestrogen or other hormone replacement therapy (HRT) may take part (see exclusion criteria for exceptions), as may women who are not taking HRT. If a woman is taking HRT she must have been on a stable dose for at least 3 months before enrolment in the study. If not on HRT, she must not have been taking it for at least 3 months before enrolment.

Exclusion Criteria:

• Dementia as indicated by a Folstein's Mini Mental State Examination (MMSE) score of < 23

• Elevated haematocrit (HCT) levels (>50%)

• Past or present history of prostatic cancer in men (Prostate Specific Antigen (PSA) levels [> age-related normal range and/or irregular prostate on prostate examination]) or breast cancer.

• Pre-existing androgenic signs or symptoms in women of concern to either subject or investigator (deep voice, hirsutism, acne, androgenic hair loss).

• Depression (Yesavage Geriatric Depression Scale (GDS) Score > 11)

• Inability to attend DEXA scan or complete other requirements of the study

• Significant cardiac failure (NYHA Class III and above)

• Significantly abnormal liver function tests (ALT, GGT, bilirubin or ALP more than 2 times the upper limit of normal)

• Nephrotic syndrome; 24h urine protein excretion > 3 grams (if baseline urinalysis reveals > 1+ proteinuria, quantification will be performed) AND/OR calculated creatinine clearance (by the equation of Baracskay and Jarjoura for ambulatory elderly subjects [Cr clearance = 4.4/serum creatinine (mmol/L) + (88-age)](63) < 30 ml/min) AND/OR serum creatinine concentration > 0.2mmol/l.

• Amputee (body mass index, creatinine clearance and body composition estimations inaccurate).

• Any disease, which in the opinion of the investigator is likely to lead to death within one year

• Testosterone or other androgen therapy (including DHEA and tibolone) in the four months before starting the study.

• Medication with cyclosporin or barbiturates