The Effects of Long Term Cyclic Testosterone Administration on Muscle Function and Bone in Older Men

• Status: Withdrawn
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: Male

Summary

The general hypothesis is that administration of testosterone to healthy, older men for 52 weeks (1 year) following a cycle of 4 weeks of testosterone administration and 4 weeks without testosterone (i.e., monthly cycled regimen) will provide the same gains in muscle strength, muscle mass, and bone density as standard of care (SOC), continuous administration of testosterone for 52 weeks.

• Phase: Phase 4
• 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. Age: 60-75 years

2. Availability of transportation (i.e., subjects must be able to provide their own transportation to UTMB)

3. Mini Mental State Exam Score (MMSE) > 26

Exclusion Criteria:

1. Exclusionary medications will be an anticoagulant (Coumadin) because of the risk of bleeding during the biopsy procedure and weekly injections and glucocorticoids because of the risk of myopathy.

2. Subjects must be able to successfully complete an exercise stress test using the Bruce protocol because the muscle biopsies in the protocol are stressful and muscle strength measurements will be done. Subjects will be excluded without exercise testing with a history of angina that occurs with exertion or at rest or a myocardial infarction within the last 12 months. Subjects that demonstrate ≥0.1 mV horizontal or downsloping ST segment depression, a drop in systolic blood pressure of ≥10 mm Hg millimeters mercury), and/or frequent or repetitive arrhythmias (defined as ≥10 premature ventricular contractions (PVC)/min, or couplets) during the stress test will be excluded.

3. Subjects with a history of stroke will be excluded.

4. Subjects with LDL cholesterol above 200 mg/dL will be excluded because testosterone administration may elevate LDL cholesterol levels further.

5. Diagnosed prostate cancer or prostatic intraepithelial neoplasia (PIN) or, by the Prostate Cancer Risk Calculator, a >30% risk of having overall prostate cancer or >7% risk of having high grade prostate cancer. This is the current exclusion criteria employed by The National Institute on Aging sponsored Testosterone Trial.

6. Men with serum total testosterone concentrations greater than 500 ng/dL will be excluded.

7. Subjects who engage in high intensity exercise training on a regular basis will be excluded.

8. Any subject who has an established major medical illness such as chronic obstructive pulmonary disease, or untreated sleep apnea will be excluded.

9. A hematocrit greater than 51%.

10. Any subject with a blood pressure on three consecutive measurements taken at one week intervals that has a systolic pressure ≥ 160mm Hg or a diastolic blood pressure ≥ 100mmHg will be excluded. Subjects will be included if they are on two or less blood pressure medications and have a blood pressure below these criteria.

11. Any subject with a history of significant liver disorders or a 3-fold elevation of liver function tests (Alk phos, alanine aminotransferase) (ALT), aspartate aminotransferase (AST).

12. Subjects currently taking anti-bone-resorptive agents such as bisphosphonates, parathyroid hormone, or calcitonin will be excluded from the study.

13. Subjects with uncontrolled endocrine or metabolic disease (e.g. liver disease, renal disease, diabetes).

14. Subjects that are HIV-seropositive or have active hepatitis*.

15. Subjects with a history of recent anabolic or corticosteroids use (within 3 months).

16. Subjects with metal fragments or metal devices contained in their bodies.

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