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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00117000

Registration number

NCT00117000

Ethics application status

Date submitted

30/06/2005

Date registered

1/07/2005

Date last updated

11/09/2006

Titles & IDs

Public title

The Effects of Testosterone and Nutritional Supplementation in the Undernourished Elderly

Scientific title

The Effects of Testosterone and Nutritional Supplementation, Alone and Combined, on the Adverse Effects of Under-Nutrition in the Elderly

Secondary ID [1]

030320

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Malnutrition

Aging

Condition category

Condition code

Diet and Nutrition

Other diet and nutrition disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

Days in hospital

Timepoint [1]

Primary outcome [2]

SF-36 quality of life scores (composite physical component score and composite mental component score).

Timepoint [2]

Secondary outcome [1]

Body composition

Timepoint [1]

Secondary outcome [2]

Muscle strength

Timepoint [2]

Secondary outcome [3]

Number of falls

Timepoint [3]

Secondary outcome [4]

Functional status (living arrangements, activities of daily living and frailty scale scores)

Timepoint [4]

Secondary outcome [5]

Mortality

Timepoint [5]

Eligibility

Key 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.

Minimum age

65 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key 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

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

Intervention assignment

Factorial

Other design features

Phase

Phase 3

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

UNKNOWN

Data analysis

Reason for early stopping/withdrawal

Other reasons

Date of first participant enrolment

Anticipated

Actual

1/07/2003

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

Royal Adelaide Hospital - Adelaide

Recruitment postcode(s) [1]

5000 - Adelaide

Funding & Sponsors

Primary sponsor type

Other

Name

University of Adelaide

Address

Country

Other collaborator category [1]

Commercial sector/industry

Name [1]

Organon

Address [1]

Country [1]

Ethics approval

Ethics application status

Summary

Brief 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.

Trial website

https://clinicaltrials.gov/study/NCT00117000

Trial related presentations / publications

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Morley JE. Testosterone replacement in older men and women. J Gend Specif Med. 2001;4(2):49-53.
Morley JE. Androgens and aging. Maturitas. 2001 Feb 28;38(1):61-71; discussion 71-3. doi: 10.1016/s0378-5122(00)00192-4.
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Bakhshi V, Elliott M, Gentili A, Godschalk M, Mulligan T. Testosterone improves rehabilitation outcomes in ill older men. J Am Geriatr Soc. 2000 May;48(5):550-3. doi: 10.1111/j.1532-5415.2000.tb05002.x.
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Zumoff B, Rosenfeld RS, Strain GW, Levin J, Fukushima DK. Sex differences in the twenty-four-hour mean plasma concentrations of dehydroisoandrosterone (DHA) and dehydroisoandrosterone sulfate (DHAS) and the DHA to DHAS ratio in normal adults. J Clin Endocrinol Metab. 1980 Aug;51(2):330-3. doi: 10.1210/jcem-51-2-330.
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Castelo-Branco C, Vicente JJ, Figueras F, Sanjuan A, Martinez de Osaba MJ, Casals E, Pons F, Balasch J, Vanrell JA. Comparative effects of estrogens plus androgens and tibolone on bone, lipid pattern and sexuality in postmenopausal women. Maturitas. 2000 Feb 15;34(2):161-8. doi: 10.1016/s0378-5122(99)00096-1.
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Padero MC, Bhasin S, Friedman TC. Androgen supplementation in older women: too much hype, not enough data. J Am Geriatr Soc. 2002 Jun;50(6):1131-40. doi: 10.1046/j.1532-5415.2002.50273.x.
Lobo RA. Androgens in postmenopausal women: production, possible role, and replacement options. Obstet Gynecol Surv. 2001 Jun;56(6):361-76. doi: 10.1097/00006254-200106000-00022.
Westaby D, Ogle SJ, Paradinas FJ, Randell JB, Murray-Lyon IM. Liver damage from long-term methyltestosterone. Lancet. 1977 Aug 6;2(8032):262-3.
Raisz LG, Wiita B, Artis A, Bowen A, Schwartz S, Trahiotis M, Shoukri K, Smith J. Comparison of the effects of estrogen alone and estrogen plus androgen on biochemical markers of bone formation and resorption in postmenopausal women. J Clin Endocrinol Metab. 1996 Jan;81(1):37-43. doi: 10.1210/jcem.81.1.8550780.
Davis SR, Burger HG. Clinical review 82: Androgens and the postmenopausal woman. J Clin Endocrinol Metab. 1996 Aug;81(8):2759-63. doi: 10.1210/jcem.81.8.8768824. No abstract available.
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Casson PR, Santoro N, Elkind-Hirsch K, Carson SA, Hornsby PJ, Abraham G, Buster JE. Postmenopausal dehydroepiandrosterone administration increases free insulin-like growth factor-I and decreases high-density lipoprotein: a six-month trial. Fertil Steril. 1998 Jul;70(1):107-10. doi: 10.1016/s0015-0282(98)00121-6.
Phillips E, Bauman C. Safety surveillance of esterified estrogens-methyltestosterone (Estratest and Estratest HS) replacement therapy in the United States. Clin Ther. 1997 Sep-Oct;19(5):1070-84. doi: 10.1016/s0149-2918(97)80060-4.
Barnhart KT, Freeman E, Grisso JA, Rader DJ, Sammel M, Kapoor S, Nestler JE. The effect of dehydroepiandrosterone supplementation to symptomatic perimenopausal women on serum endocrine profiles, lipid parameters, and health-related quality of life. J Clin Endocrinol Metab. 1999 Nov;84(11):3896-902. doi: 10.1210/jcem.84.11.6153.
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Shifren JL, Braunstein GD, Simon JA, Casson PR, Buster JE, Redmond GP, Burki RE, Ginsburg ES, Rosen RC, Leiblum SR, Caramelli KE, Mazer NA. Transdermal testosterone treatment in women with impaired sexual function after oophorectomy. N Engl J Med. 2000 Sep 7;343(10):682-8. doi: 10.1056/NEJM200009073431002.
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Public notes

Contacts

Principal investigator

Name

Ian M Chapman, MBBS, PhD

Address

University of Adelaide

Country

Phone

Fax

Contact person for public queries

Name

Address

Country

Phone

Fax

Contact person for scientific queries

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00117000

Trial Review

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00117000