Exercise and Testosterone Therapy in Elderly Men With Physical Frailty

NCT00345969 | Completed Phase 3 Results

• 1 other identifier: HSC 02-1108
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Physical Frailty; Hip Fracture; Elective Hip Replacement; Hypogonadism

Keywords

Testosterone Replacement Therapy; Physical Frailty; Hip Fracture

Outcome Measures

Primary Outcomes (2)

• Mean Change in Total Lean Body Mass

  Total Lean Mass measured by Dual X-ray Absorptiometry (DXA)

  Baseline and Six Months

• Change in Skeletal Muscle Strength by 1-RM

  One-repetition maximum strength for leg extension

  Baseline and Six Months

Secondary Outcomes (6)

• Change in Isokinetic Leg Extension Torque at 0 Deg/Sec

  Baseline and Six Months

• Change in Leg Extension Torque at 60 Deg/Sec

  Baseline and Six Months

• Change in Total Body Fat Mass

  Baseline and Six Months

• Change in Femoral Bone Mineral Density (BMD)

  Baseline and Six Months

• Change in Total Modified Physical Performance (mPPT) Score

  Baseline and Six Months

Other Outcomes (5)

• Change in Serum Prostate Specific Antigen (PSA) Level

  Baseline and Six Months

• Change in Hematocrit

  Baseline and Six Months

• Change in Serum Total Cholesterol Level

  Baseline and Six Months

Study Arms (2)

Transdermal Testosterone gel (1%)

ACTIVE COMPARATOR

Transdermal testosterone 1% gel (Androgel) provided as 2.5 gm and/or 5 gm gel packets with dose titration and monthly dose adjustments to achieve and maintain serum total testosterone level between 500-900 mg/dL. Gel to be applied daily by participants. Participants are blinded to the contents of the gel packets. Participants in this arm also perform supervised exercise training for 6 months.

Drug: Transdermal Testosterone gel (1%); Behavioral: Supervised exercise training

Placebo gel

PLACEBO COMPARATOR

Inactive topical gel identical in appearance to the active medication, provided in packets identical to the packaging for the active medication. Gel to be applied daily by participants. Participants are blinded to the contents of the gel packets. Participants in this arm also perform supervised exercise training for 6 months.

Behavioral: Supervised exercise training

Interventions

Transdermal Testosterone gel (1%) DRUG

Transdermal testosterone replacement therapy with Androgel(TM). Daily application of gel at 5 mg, 7.5 gm, or 10 gm for six months. Target serum total testosterone level between 500-900 ng/dl.

Also known as: Androgel

Transdermal Testosterone gel (1%)

Supervised exercise training BEHAVIORAL

Supervised exercise training performed on site at academic medical center exercise facility. Exercise training consisted of 2 months of flexibility, balance, treadmill walking, and physical therapy-type exercises, followed by 4 months of progressive resistance training.

Placebo gel; Transdermal Testosterone gel (1%)

Eligibility Criteria

• Age: 65 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Male, age 65 years and older
• Total serum testosterone level \< 350 ng/dl
• Total Modified Physical Performance Test Score \<28

You may not qualify if:

• Inability to walk 50 feet independently
• Current use of estrogen, progestin, or androgen containing compound
• Diagnosis of dementia of severity sufficient to interfere with informed consent or compliance with the protocol, or a score of 11 or greater on the Short Blessed Test of Orientation, Memory and Concentration
• Visual or hearing impairments that interfere with following directions
• Cardiopulmonary disease (recent MI, unstable angina or CHF, etc.), neuromuscular impairments, or unstable medical condition that would contraindicate progressive resistance exercise training
• History of prostate cancer or hormone dependent neoplasia
• PSA 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Solvay Pharmaceuticals: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Hip Fractures; Hypogonadism

Interventions

Testosterone

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Limitations and Caveats

Small number of subjects enrolled, single site trial, included both hip fracture patients and a few patients with elective hip joint replacement.

Results Point of Contact

• Title: Ellen F. Binder, MD
• Organization: Washington University School of Medicine

ebinder@wustl.edu

314-286-2707

Study Officials

• Ellen F. Binder, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 27, 2006
• First Posted: June 29, 2006
• Study Start: November 1, 2004
• Primary Completion: February 1, 2009
• Study Completion: August 1, 2009
• Last Updated: February 22, 2018
• Results First Posted: February 22, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)