The Effects of Testosterone and Nutritional Supplementation in the Undernourished Elderly

NCT00117000 | Unknown Phase 3

• 1 other identifier: 030320
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Malnutrition; Aging

Keywords

testosterone; food, formulated; malnutrition; undernutrition; aging; aged; aged, 80 and over; frail elderly

Outcome Measures

Primary Outcomes (2)

• Days in hospital

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

Secondary Outcomes (5)

• Body composition

• Muscle strength

• Number of falls

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

• Mortality

Interventions

testosterone undecanoate DRUG

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Adelaide: lead
• Organon: collaborator

Study Sites (1)

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

Related Publications (70)

• Evans WJ, Campbell WW. Sarcopenia and age-related changes in body composition and functional capacity. J Nutr. 1993 Feb;123(2 Suppl):465-8. doi: 10.1093/jn/123.suppl_2.465.

  PMID: 8429405 BACKGROUND

• Tenover JS. Androgen replacement therapy to reverse and/or prevent age-associated sarcopenia in men. Baillieres Clin Endocrinol Metab. 1998 Oct;12(3):419-25. doi: 10.1016/s0950-351x(98)80153-5.

  PMID: 10332563 BACKGROUND

• Roshan S, Nader S, Orlander P. Review: Ageing and hormones. Eur J Clin Invest. 1999 Mar;29(3):210-3. doi: 10.1046/j.1365-2362.1999.00436.x.

  PMID: 10202377 BACKGROUND

• Volpi E, Sheffield-Moore M, Rasmussen BB, Wolfe RR. Basal muscle amino acid kinetics and protein synthesis in healthy young and older men. JAMA. 2001 Sep 12;286(10):1206-12. doi: 10.1001/jama.286.10.1206.

  PMID: 11559266 BACKGROUND

• Newman AB, Yanez D, Harris T, Duxbury A, Enright PL, Fried LP; Cardiovascular Study Research Group. Weight change in old age and its association with mortality. J Am Geriatr Soc. 2001 Oct;49(10):1309-18. doi: 10.1046/j.1532-5415.2001.49258.x.

  PMID: 11890489 BACKGROUND

• MacIntosh C, Morley JE, Chapman IM. The anorexia of aging. Nutrition. 2000 Oct;16(10):983-95. doi: 10.1016/s0899-9007(00)00405-6. No abstract available.

  PMID: 11054605 BACKGROUND

• Morley JE. Anorexia in older persons: epidemiology and optimal treatment. Drugs Aging. 1996 Feb;8(2):134-55. doi: 10.2165/00002512-199608020-00007.

  PMID: 8845587 BACKGROUND

• Visvanathan R, Macintosh C, Callary M, Penhall R, Horowitz M, Chapman I. The nutritional status of 250 older Australian recipients of domiciliary care services and its association with outcomes at 12 months. J Am Geriatr Soc. 2003 Jul;51(7):1007-11. doi: 10.1046/j.1365-2389.2003.51317.x.

  PMID: 12834523 BACKGROUND

• Morley JE. Testosterone replacement and the physiologic aspects of aging in men. Mayo Clin Proc. 2000 Jan;75 Suppl:S83-7.

  PMID: 10959223 BACKGROUND

• Melton LJ 3rd, Khosla S, Riggs BL. Epidemiology of sarcopenia. Mayo Clin Proc. 2000 Jan;75 Suppl:S10-2; discussion S12-3.

  PMID: 10959209 BACKGROUND

• Roubenoff R, Rall LC, Veldhuis JD, Kehayias JJ, Rosen C, Nicolson M, Lundgren N, Reichlin S. The relationship between growth hormone kinetics and sarcopenia in postmenopausal women: the role of fat mass and leptin. J Clin Endocrinol Metab. 1998 May;83(5):1502-6. doi: 10.1210/jcem.83.5.4809.

  PMID: 9589646 BACKGROUND

• Davis S. Androgen replacement in women: a commentary. J Clin Endocrinol Metab. 1999 Jun;84(6):1886-91. doi: 10.1210/jcem.84.6.5802.

  PMID: 10372681 BACKGROUND

• Zumoff B, Strain GW, Miller LK, Rosner W. Twenty-four-hour mean plasma testosterone concentration declines with age in normal premenopausal women. J Clin Endocrinol Metab. 1995 Apr;80(4):1429-30. doi: 10.1210/jcem.80.4.7714119.

  PMID: 7714119 BACKGROUND

• Burger HG, Dudley EC, Cui J, Dennerstein L, Hopper JL. A prospective longitudinal study of serum testosterone, dehydroepiandrosterone sulfate, and sex hormone-binding globulin levels through the menopause transition. J Clin Endocrinol Metab. 2000 Aug;85(8):2832-8. doi: 10.1210/jcem.85.8.6740.

  PMID: 10946891 BACKGROUND

• Morley JE. Testosterone replacement in older men and women. J Gend Specif Med. 2001;4(2):49-53.

  PMID: 11480098 BACKGROUND

• Morley JE. Androgens and aging. Maturitas. 2001 Feb 28;38(1):61-71; discussion 71-3. doi: 10.1016/s0378-5122(00)00192-4.

  PMID: 11311591 BACKGROUND

• Davis SR, Burger HG. The rationale for physiological testosterone replacement in women. Baillieres Clin Endocrinol Metab. 1998 Oct;12(3):391-405. doi: 10.1016/s0950-351x(98)80115-8.

  PMID: 10332561 BACKGROUND

• Tenover JL. Testosterone replacement therapy in older adult men. Int J Androl. 1999 Oct;22(5):300-6. doi: 10.1046/j.1365-2605.1999.00184.x.

  PMID: 10509230 BACKGROUND

• Ly LP, Jimenez M, Zhuang TN, Celermajer DS, Conway AJ, Handelsman DJ. A double-blind, placebo-controlled, randomized clinical trial of transdermal dihydrotestosterone gel on muscular strength, mobility, and quality of life in older men with partial androgen deficiency. J Clin Endocrinol Metab. 2001 Sep;86(9):4078-88. doi: 10.1210/jcem.86.9.7821.

  PMID: 11549629 BACKGROUND

• Amory JK, Chansky HA, Chansky KL, Camuso MR, Hoey CT, Anawalt BD, Matsumoto AM, Bremner WJ. Preoperative supraphysiological testosterone in older men undergoing knee replacement surgery. J Am Geriatr Soc. 2002 Oct;50(10):1698-701. doi: 10.1046/j.1532-5415.2002.50462.x.

  PMID: 12366624 BACKGROUND

• 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.

  PMID: 10811549 BACKGROUND

• Chakravarti S, Collins WP, Forecast JD, Newton JR, Oram DH, Studd JW. Hormonal profiles after the menopause. Br Med J. 1976 Oct 2;2(6039):784-7. doi: 10.1136/bmj.2.6039.784.

  PMID: 974609 BACKGROUND

• 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.

  PMID: 6447161 BACKGROUND

• Davis SR, McCloud P, Strauss BJ, Burger H. Testosterone enhances estradiol's effects on postmenopausal bone density and sexuality. Maturitas. 1995 Apr;21(3):227-36. doi: 10.1016/0378-5122(94)00898-h.

  PMID: 7616872 BACKGROUND

• Davis SR, Tran J. Testosterone influences libido and well being in women. Trends Endocrinol Metab. 2001 Jan-Feb;12(1):33-7. doi: 10.1016/s1043-2760(00)00333-7.

  PMID: 11137039 BACKGROUND

• 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.

  PMID: 10714911 BACKGROUND

• Gruber DM, Sator MO, Kirchengast S, Joura EA, Huber JC. Effect of percutaneous androgen replacement therapy on body composition and body weight in postmenopausal women. Maturitas. 1998 Jun 17;29(3):253-9. doi: 10.1016/s0378-5122(98)00031-0.

  PMID: 9699197 BACKGROUND

• 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.

  PMID: 12110078 BACKGROUND

• 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.

  PMID: 11466487 BACKGROUND

• 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.

  PMID: 69876 BACKGROUND

• 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.

  PMID: 8550780 BACKGROUND

• 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.

  PMID: 8768824 BACKGROUND

• Burger HG, Hailes J, Menelaus M, Nelson J, Hudson B, Balazs N. The management of persistent menopausal symptoms with oestradiol-testosterone implants: clinical, lipid and hormonal results. Maturitas. 1984 Dec;6(4):351-8. doi: 10.1016/0378-5122(84)90008-2.

  PMID: 6442755 BACKGROUND

• Burger H, Hailes J, Nelson J, Menelaus M. Effect of combined implants of oestradiol and testosterone on libido in postmenopausal women. Br Med J (Clin Res Ed). 1987 Apr 11;294(6577):936-7. doi: 10.1136/bmj.294.6577.936. No abstract available.

  PMID: 3107663 BACKGROUND

• Miller K, Corcoran C, Armstrong C, Caramelli K, Anderson E, Cotton D, Basgoz N, Hirschhorn L, Tuomala R, Schoenfeld D, Daugherty C, Mazer N, Grinspoon S. Transdermal testosterone administration in women with acquired immunodeficiency syndrome wasting: a pilot study. J Clin Endocrinol Metab. 1998 Aug;83(8):2717-25. doi: 10.1210/jcem.83.8.5051.

  PMID: 9709937 BACKGROUND

• Mortola JF, Yen SS. The effects of oral dehydroepiandrosterone on endocrine-metabolic parameters in postmenopausal women. J Clin Endocrinol Metab. 1990 Sep;71(3):696-704. doi: 10.1210/jcem-71-3-696.

  PMID: 2144295 BACKGROUND

• 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.

  PMID: 9660430 BACKGROUND

• 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.

  PMID: 9385494 BACKGROUND

• 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.

  PMID: 10566625 BACKGROUND

• Diamond P, Cusan L, Gomez JL, Belanger A, Labrie F. Metabolic effects of 12-month percutaneous dehydroepiandrosterone replacement therapy in postmenopausal women. J Endocrinol. 1996 Sep;150 Suppl:S43-50.

  PMID: 8943786 BACKGROUND

• 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.

  PMID: 10974131 BACKGROUND

• Dobs AS, Nguyen T, Pace C, Roberts CP. Differential effects of oral estrogen versus oral estrogen-androgen replacement therapy on body composition in postmenopausal women. J Clin Endocrinol Metab. 2002 Apr;87(4):1509-16. doi: 10.1210/jcem.87.4.8362.

  PMID: 11932273 BACKGROUND

• Myers LS, Dixen J, Morrissette D, Carmichael M, Davidson JM. Effects of estrogen, androgen, and progestin on sexual psychophysiology and behavior in postmenopausal women. J Clin Endocrinol Metab. 1990 Apr;70(4):1124-31. doi: 10.1210/jcem-70-4-1124.

  PMID: 1690746 BACKGROUND

• Watts NB, Notelovitz M, Timmons MC, Addison WA, Wiita B, Downey LJ. Comparison of oral estrogens and estrogens plus androgen on bone mineral density, menopausal symptoms, and lipid-lipoprotein profiles in surgical menopause. Obstet Gynecol. 1995 Apr;85(4):529-37. doi: 10.1016/0029-7844(94)00448-m.

  PMID: 7898828 BACKGROUND

• Penotti M, Sironi L, Cannata L, Vigano P, Casini A, Gabrielli L, Vignali M. Effects of androgen supplementation of hormone replacement therapy on the vascular reactivity of cerebral arteries. Fertil Steril. 2001 Aug;76(2):235-40. doi: 10.1016/s0015-0282(01)01923-9.

  PMID: 11476766 BACKGROUND

• Morley JE. Anorexia of aging: physiologic and pathologic. Am J Clin Nutr. 1997 Oct;66(4):760-73. doi: 10.1093/ajcn/66.4.760.

  PMID: 9322549 BACKGROUND

• Mathey MF, Siebelink E, de Graaf C, Van Staveren WA. Flavor enhancement of food improves dietary intake and nutritional status of elderly nursing home residents. J Gerontol A Biol Sci Med Sci. 2001 Apr;56(4):M200-5. doi: 10.1093/gerona/56.4.m200.

  PMID: 11283191 BACKGROUND

• Rolls BJ, McDermott TM. Effects of age on sensory-specific satiety. Am J Clin Nutr. 1991 Dec;54(6):988-96. doi: 10.1093/ajcn/54.6.988.

  PMID: 1957832 BACKGROUND

• Ritchie CS, Burgio KL, Locher JL, Cornwell A, Thomas D, Hardin M, Redden D. Nutritional status of urban homebound older adults. Am J Clin Nutr. 1997 Oct;66(4):815-8. doi: 10.1093/ajcn/66.4.815.

  PMID: 9322555 BACKGROUND

• Omran ML, Morley JE. Assessment of protein energy malnutrition in older persons, Part II: Laboratory evaluation. Nutrition. 2000 Feb;16(2):131-40. doi: 10.1016/s0899-9007(99)00251-8.

  PMID: 10696638 BACKGROUND

• Lumbers M, New SA, Gibson S, Murphy MC. Nutritional status in elderly female hip fracture patients: comparison with an age-matched home living group attending day centres. Br J Nutr. 2001 Jun;85(6):733-40. doi: 10.1079/bjn2001350.

  PMID: 11430778 BACKGROUND

• Middleton MH, Nazarenko G, Nivison-Smith I, Smerdely P. Prevalence of malnutrition and 12-month incidence of mortality in two Sydney teaching hospitals. Intern Med J. 2001 Nov;31(8):455-61. doi: 10.1046/j.1445-5994.2001.00109.x.

  PMID: 11720058 BACKGROUND

• Sullivan DH, Walls RC, Lipschitz DA. Protein-energy undernutrition and the risk of mortality within 1 y of hospital discharge in a select population of geriatric rehabilitation patients. Am J Clin Nutr. 1991 Mar;53(3):599-605. doi: 10.1093/ajcn/53.3.599.

  PMID: 1900382 BACKGROUND

• Abbasi AA, Rudman D. Undernutrition in the nursing home: prevalence, consequences, causes and prevention. Nutr Rev. 1994 Apr;52(4):113-22. doi: 10.1111/j.1753-4887.1994.tb01403.x.

  PMID: 8028816 BACKGROUND

• de Jong N, Chin A Paw MJ, de Groot LC, de Graaf C, Kok FJ, van Staveren WA. Functional biochemical and nutrient indices in frail elderly people are partly affected by dietary supplements but not by exercise. J Nutr. 1999 Nov;129(11):2028-36. doi: 10.1093/jn/129.11.2028.

  PMID: 10539780 BACKGROUND

• Lauque S, Arnaud-Battandier F, Mansourian R, Guigoz Y, Paintin M, Nourhashemi F, Vellas B. Protein-energy oral supplementation in malnourished nursing-home residents. A controlled trial. Age Ageing. 2000 Jan;29(1):51-6. doi: 10.1093/ageing/29.1.51.

  PMID: 10690696 BACKGROUND

• Gray-Donald K, Payette H, Boutier V, Page S. Evaluation of the dietary intake of homebound elderly and the feasibility of dietary supplementation. J Am Coll Nutr. 1994 Jun;13(3):277-84. doi: 10.1080/07315724.1994.10718409.

  PMID: 8077577 BACKGROUND

• Tkatch L, Rapin CH, Rizzoli R, Slosman D, Nydegger V, Vasey H, Bonjour JP. Benefits of oral protein supplementation in elderly patients with fracture of the proximal femur. J Am Coll Nutr. 1992 Oct;11(5):519-25. doi: 10.1080/07315724.1992.10718256.

  PMID: 1452950 BACKGROUND

• Delmi M, Rapin CH, Bengoa JM, Delmas PD, Vasey H, Bonjour JP. Dietary supplementation in elderly patients with fractured neck of the femur. Lancet. 1990 Apr 28;335(8696):1013-6. doi: 10.1016/0140-6736(90)91073-j.

  PMID: 1970070 BACKGROUND

• Schurch MA, Rizzoli R, Slosman D, Vadas L, Vergnaud P, Bonjour JP. Protein supplements increase serum insulin-like growth factor-I levels and attenuate proximal femur bone loss in patients with recent hip fracture. A randomized, double-blind, placebo-controlled trial. Ann Intern Med. 1998 May 15;128(10):801-9. doi: 10.7326/0003-4819-128-10-199805150-00002.

  PMID: 9599191 BACKGROUND

• Sullivan DH, Patch GA, Walls RC, Lipschitz DA. Impact of nutrition status on morbidity and mortality in a select population of geriatric rehabilitation patients. Am J Clin Nutr. 1990 May;51(5):749-58. doi: 10.1093/ajcn/51.5.749.

  PMID: 2110413 BACKGROUND

• Baracskay D, Jarjoura D, Cugino A, Blend D, Rutecki GW, Whittier FC. Geriatric renal function: estimating glomerular filtration in an ambulatory elderly population. Clin Nephrol. 1997 Apr;47(4):222-8.

  PMID: 9128788 BACKGROUND

• Vellas B, Guigoz Y, Garry PJ, Nourhashemi F, Bennahum D, Lauque S, Albarede JL. The Mini Nutritional Assessment (MNA) and its use in grading the nutritional state of elderly patients. Nutrition. 1999 Feb;15(2):116-22. doi: 10.1016/s0899-9007(98)00171-3.

  PMID: 9990575 BACKGROUND

• Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. doi: 10.1016/0022-3956(75)90026-6. No abstract available.

  PMID: 1202204 BACKGROUND

• Yesavage JA, Brink TL, Rose TL, Lum O, Huang V, Adey M, Leirer VO. Development and validation of a geriatric depression screening scale: a preliminary report. J Psychiatr Res. 1982-1983;17(1):37-49. doi: 10.1016/0022-3956(82)90033-4.

  PMID: 7183759 BACKGROUND

• Reuben DB, Siu AL. An objective measure of physical function of elderly outpatients. The Physical Performance Test. J Am Geriatr Soc. 1990 Oct;38(10):1105-12. doi: 10.1111/j.1532-5415.1990.tb01373.x.

  PMID: 2229864 BACKGROUND

• 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.

  PMID: 11253156 BACKGROUND

• Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.

  PMID: 1593914 BACKGROUND

• Mazess RB, Barden HS, Bisek JP, Hanson J. Dual-energy x-ray absorptiometry for total-body and regional bone-mineral and soft-tissue composition. Am J Clin Nutr. 1990 Jun;51(6):1106-12. doi: 10.1093/ajcn/51.6.1106.

  PMID: 2349926 BACKGROUND

• Chapman IM, Visvanathan R, Hammond AJ, Morley JE, Field JB, Tai K, Belobrajdic DP, Chen RY, Horowitz M. Effect of testosterone and a nutritional supplement, alone and in combination, on hospital admissions in undernourished older men and women. Am J Clin Nutr. 2009 Mar;89(3):880-9. doi: 10.3945/ajcn.2008.26538. Epub 2009 Jan 14.

  PMID: 19144729 DERIVED

MeSH Terms

Conditions

Malnutrition

Interventions

testosterone undecanoate

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Ian M Chapman, MBBS, PhD

  University of Adelaide

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 30, 2005
• First Posted: July 1, 2005
• Study Start: July 1, 2003
• Study Completion: February 1, 2007
• Last Updated: September 11, 2006

Record last verified: 2006-09

Locations

AU (1)