Cycled Testosterone Therapy to Improve Physical Function in Frail Nursing Home Residents

• Status: Terminated
• Trial end date: 2016-09-20
• Target enrollment: 0
• Participant gender: All

Summary

Frailty is a recognized cause for disability, hospitalization, and mortality in nursing home residents. Testosterone treatment is among the potentially beneficial treatments in addition to resistance exercise for improving muscle strength and mass in frail adults. The investigators have demonstrated that cycled administration of testosterone improves muscle mass and strength in healthy adults. It is proposed that cycled testosterone administration may be an effective adjuvant therapy for frail older men and women during rehabilitation programs. The hypothesis is that testosterone treatment in addition to standard-of-care (SOC) rehabilitation will result in improved muscle mass and physical function when compared to patients receiving SOC only. Therefore, in a randomized, double-blind, placebo controlled study, the investigators will test the effects of cycled testosterone administration (2 week on treatment, 2 weeks off treatment) on body composition and physical function in male and female nursing home residents undergoing rehabilitative care. Primary outcomes will be assessed before and after 10 weeks of treatment using bioelectric impedance, handgrip dynamometers, short physical performance battery (SPPB), and quality of life (QOL) questionnaires. Data from this pilot project will become the foundation for the development of a larger long-term project solicitation to the NIH aimed at elucidating the efficacy of testosterone treatment on physical function and independence in frail older adults.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: The University of Texas Medical Branch, Galveston
• Treatments: Methyltestosterone; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

Criteria

Inclusion Criteria:

1. Male or Female

2. Ages: 60 years or older

3. Starting rehabilitative care

Exclusion Criteria:

1. Inability to perform the functional tests specific to the study protocol

2. Diagnosed with carcinomas of the breast or with known or suspected carcinomas of the prostate.

3. Uncontrolled endocrine or metabolic disease (e.g. liver disease, renal disease, diabetes).

4. Uncontrolled hypertension. Systolic blood pressure =/> 160mm Hg or a diastolic blood pressure =/> 100mm Hg on three consecutive measurements taken at one-week intervals. Testosterone, other anabolic steroids and glucocorticoids can cause fluid retention that could worsen uncontrolled hypertension. Subjects will be included if they are on two or less blood pressure medications and have a blood pressure below these criteria.

5. History of significant liver disorders or a 3-fold elevation of liver function tests (Alk phos, ALT, AST). Testosterone can have hepatotoxic effects in some subjects and should be used with careful monitoring of LFTs (liver function), though injections of testosterone at a 100 mg dose is not typically sufficient to negatively affect LFTs.

6. History of angina that occurs with exertion or at rest or a myocardial infarction within the last 12 months.

7. LDL cholesterol greater than 200 mg/dL as testosterone administration may elevate LDL cholesterol levels further, though this is not anticipated with testosterone injections of 100 mg/wk.

8. Hematocrit greater than 51%.

9. Established chronic obstructive pulmonary disease, or untreated sleep apnea.

10. Implanted artificial pacemaker/defibrillator. BIA uses small currents and is not recommended for participants with a pacemaker.

11. Diagnosed systemic fungal infections.

12. Positive screening for HIV or active hepatitis*.

13. Use of or history of recent anabolic steroid use (within 3 months).

14. Alcohol or drug abuse.

15. Any other condition or event considered exclusionary by the PI and covering faculty physician.

16. Vulnerable populations including: individuals unable to consent on their own behalf, prisoners and pregnant women.

• Subjects excluded due to positive screening results, including HIV, HBV or HCV, will be immediately scheduled for counseling and follow-up testing as needed, and will be advised to consult their primary physician.