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

NCT02679274 | Terminated Early Phase 1 Results

• 1 other identifier: 15-0176
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Aging

Keywords

Aging, Frailty, Hypogonadism

Outcome Measures

Primary Outcomes (1)

• Change in Fat-free Mass as Measured by Bioelectric Impediance Analysis (BIA)

  Fat-free Mass (kg) calculated from total weight (kg) and percent body fat (%) obtained during bioelectric impedance analysis (BIA).

  0 to 10 Weeks

Secondary Outcomes (12)

• Change in Handgrip Strength

  0 to 10 Weeks

• Change in Knee Extension Strength (Seated)

  0 to 10 Weeks

• Change in Hip Abduction Strength (Supine)

  0 to 10 Weeks

• Side by Side Balance as Measured by Short Physical Performance Battery (SPPB) at Baseline

  baseline

• Side by Side Balance as Measured by Short Physical Performance Battery (SPPB) at 10 Weeks

  10 Weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo injection (saline) to be received on weeks 0, 1, 4, 5, 8 and 9.

Drug: Placebo

Testosterone

EXPERIMENTAL

Testosterone Enanthate injections (25mg/injection females; 100mg/injection males) to be received on weeks 0, 1, 4, 5, 8 and 9.

Drug: Testosterone

Interventions

Placebo DRUG

Intermittent intramuscular injections of saline (males and females).

Also known as: Saline

Placebo

Testosterone DRUG

Intermittent intramuscular injections of 100 mg Testosterone Enanthate (males) or 25 mg Testosterone Enanthate (females).

Also known as: Testosterone Enanthate

Testosterone

Eligibility Criteria

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

You may qualify if:

• Male or Female
• Ages: 60 years or older
• Starting rehabilitative care

You may not qualify if:

• Inability to perform the functional tests specific to the study protocol
• Diagnosed with carcinomas of the breast or with known or suspected carcinomas of the prostate.
• Uncontrolled endocrine or metabolic disease (e.g. liver disease, renal disease, diabetes).
• 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.
• 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.
• History of angina that occurs with exertion or at rest or a myocardial infarction within the last 12 months.
• 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.
• Hematocrit greater than 51%.
• Established chronic obstructive pulmonary disease, or untreated sleep apnea.
• Implanted artificial pacemaker/defibrillator. BIA uses small currents and is not recommended for participants with a pacemaker.
• Diagnosed systemic fungal infections.
• Positive screening for HIV or active hepatitis\*.
• Use of or history of recent anabolic steroid use (within 3 months).
• Alcohol or drug abuse.
• Vulnerable populations including: individuals unable to consent on their own behalf, prisoners and pregnant women.

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead

Study Sites (2)

Gulf Health Care Center

Galveston, Texas, 77555, United States

Location

Gulf Health Care Center

Texas City, Texas, 77590, United States

Location

MeSH Terms

Conditions

Frailty; Hypogonadism

Interventions

Sodium Chloride; Testosterone; testosterone enanthate

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: Dr. Edgar L. Dillon
• Organization: University of Texas Medical Branch

eldillon@utmb.edu

409 772 8701

Study Officials

• Edgar L Dillon, PhD

  University of Texas Medical Branch (UTMB)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2015
• First Posted: February 10, 2016
• Study Start: February 16, 2016
• Primary Completion: September 20, 2016
• Study Completion: September 20, 2016
• Last Updated: February 18, 2019
• Results First Posted: February 18, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)