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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01417364
• Date of registration: 12/08/2011
• Primary sponsor: The University of Texas, Galveston
• Public title: The Effects of Long Term Cyclic Testosterone Administration on Muscle Function and Bone in Older Men
• Scientific title: The Effects of Long Term Cyclic Testosterone Administration on Muscle Function and Bone in Older Men
• Date of first enrolment: September 2011
• Target sample size: 45
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01417364
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Charles R Gilkison, RN, MSN

Key inclusion & exclusion 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,
and/or frequent or repetitive arrhythmias (defined as =10 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, ALT, 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.



Age minimum: 60 Years
Age maximum: 75 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Sarcopenia

Intervention(s)

Drug: Placebo

Drug: Testosterone enanthate

Primary Outcome(s)

Bone density [Time Frame: 1 year]

Lean Body Mass and Muscle Volume [Time Frame: 1 year]

Muscle Strength [Time Frame: 1 year]

Secondary Outcome(s)

Assessment of bone metabolism. [Time Frame: 1 year]

Assessment of cardiac stiffness [Time Frame: 1 year]

Assessment of Inflammation [Time Frame: 1 year]

Assessment of muscle signaling [Time Frame: 1 year]

Assessment of Physical Performance [Time Frame: 1 year]

Assessment of risk factors [Time Frame: 1 year]

Secondary ID(s)

11-132

Source(s) of Monetary Support

Please refer to primary and secondary sponsors