Phase 3 N=25 Randomized Quadruple-blind Treatment

Exercise and Testosterone Therapy in Elderly Men With Physical Frailty

Physical Frailty · Hip Fracture · Elective Hip Replacement · Hypogonadism

Bottom Line

View on ClinicalTrials.gov: NCT00345969 ↗

Enrolled (actual)

Serious AEs

4.0%

Results posted

Feb 2018

Primary outcome: Primary: Mean Change in Total Lean Body Mass — 0.5; 2.3 kg — p=0.01

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Transdermal Testosterone gel (1%) (Drug); Supervised exercise training (Behavioral)
Age: Older Adult · 65+ yrs
Sex: Male
Sponsor: Washington University School of Medicine
Primary completion: Feb 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Change in Total Lean Body Mass	0.5; 2.3	0.01 sig
PRIMARY Change in Skeletal Muscle Strength by 1-RM	59.2; 70.3	0.55
SECONDARY Change in Isokinetic Leg Extension Torque at 0 Deg/Sec	10.4; 19.8	0.23
SECONDARY Change in Leg Extension Torque at 60 Deg/Sec	12.7; 19.4	0.43
SECONDARY Change in Total Body Fat Mass	-0.51; -1.1	0.33
SECONDARY Change in Femoral Bone Mineral Density (BMD)	-0.008; 0.084	0.93
SECONDARY Change in Total Modified Physical Performance (mPPT) Score	5.0; 2.8	0.24
SECONDARY Change in Serum Testosterone Level	-15.3; 121.2	0.13

Summary

The primary aim of this study is to determine, in hypogonadal older men with physical frailty, whether exercise training combined with testosterone replacement therapy can improve skeletal muscle strength, and lean mass, to a greater degree than exercise training alone.

Eligibility Criteria

Inclusion Criteria

Male, age 65 years and older
Total serum testosterone level 4 ng/ml
Serum liver transaminase levels of greater than 2 standard deviations above normal
Use of drugs for osteoporosis for less than 1 year
Current participation in a vigorous exercise or weight-training program more than once per week
History of sleep apnea requiring use of CPAP
Uncontrolled thyroid disease
Diagnosis of cancer within the past 5 years other than superficial skin cancer (squamous or basal cell)
hematocrit > 50%
AUA symptom score > 16.
History of alcohol or substance abuse
Presence of severe facial acne
Active symptoms of depression with GDS score > 5 and symptoms severe enough to cause >5% weight loss in previous 3 months or interfere with research assessments

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Data sourced from ClinicalTrials.gov (NCT00345969). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.