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

NCT01417364 | Withdrawn Phase 4 DMC

• 1 other identifier: 11-132
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sarcopenia

Keywords

Sarcopenia; Aging muscle; Testosterone administration; Bone metabolism

Outcome Measures

Primary Outcomes (3)

• Muscle Strength

  Muscle strength will be measured using a Biodex 4. All strength measures will be normalized by dividing absolute strength by lean muscle mass.

  1 year

• Lean Body Mass and Muscle Volume

  Lean body mass will be determined by DEXA and muscle volume by MRI.

  1 year

• Bone density

  Bone density will be determined by DEXA.

  1 year

Secondary Outcomes (6)

• Assessment of risk factors

  1 year

• Assessment of Physical Performance

  1 year

• Assessment of muscle signaling

  1 year

• Assessment of bone metabolism.

  1 year

• Assessment of Inflammation

  1 year

Study Arms (3)

Testosterone weekly injections continuously

ACTIVE COMPARATOR

Testosterone enanthate 100 mg Intramuscular (IM) weekly injections throughout the study

Drug: Testosterone enanthate

Cyclic testosterone administration

EXPERIMENTAL

Testosterone injections 100 mg. IM weekly for one month alternating with placebo injections weekly for one month throughout the study

Drug: Testosterone enanthate

Placebo injections

PLACEBO COMPARATOR

Placebo injections weekly throughout the study.

Drug: Placebo

Interventions

Testosterone enanthate DRUG

100 mg. IM weekly throughout study

Testosterone weekly injections continuously

Placebo DRUG

Injected IM weekly throughout study

Placebo injections

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 60-75 years
• Availability of transportation (i.e., subjects must be able to provide their own transportation to UTMB)
• Mini Mental State Exam Score (MMSE) \> 26

You may not qualify if:

• 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.
• Subjects with a history of stroke will be excluded.
• Subjects with LDL cholesterol above 200 mg/dL will be excluded because testosterone administration may elevate LDL cholesterol levels further.
• Men with serum total testosterone concentrations greater than 500 ng/dL will be excluded.
• Subjects who engage in high intensity exercise training on a regular basis will be excluded.
• Any subject who has an established major medical illness such as chronic obstructive pulmonary disease, or untreated sleep apnea will be excluded.
• A hematocrit greater than 51%.
• 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.
• 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).
• Subjects currently taking anti-bone-resorptive agents such as bisphosphonates, parathyroid hormone, or calcitonin will be excluded from the study.
• Subjects with uncontrolled endocrine or metabolic disease (e.g. liver disease, renal disease, diabetes).
• Subjects that are HIV-seropositive or have active hepatitis\*.
• Subjects with a history of recent anabolic or corticosteroids use (within 3 months).
• Subjects with metal fragments or metal devices contained in their bodies.

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead

Study Sites (1)

The University of Texas Medical Branch, Galveston

Galveston, Texas, 77555, United States

Location

MeSH Terms

Conditions

Sarcopenia

Interventions

testosterone enanthate

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2011
• First Posted: August 16, 2011
• Study Start: January 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2017
• Last Updated: October 2, 2015

Record last verified: 2015-09

Locations

US (1)