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| Name | Class |
|---|---|
| Solvay Pharmaceuticals | INDUSTRY |
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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.
Decreases in physical abilities, including losses of strength, endurance, balance, and coordination are major causes of disability and loss of independence in older men. Such individuals are at high risk for injurious falls, hospitalization, and use of supportive services. Age-associated testosterone deficiency may contribute to deficits in muscle mass and strength that are common in this patient population.
The primary aim of this study is to determine, in hypogonadal older men with physical frailty, whether six months of exercise training combined with testosterone replacement therapy can improve skeletal muscle mass and skeletal muscle strength, to a greater degree than six months of exercise training alone.
Secondary study aims are to determine in hypogonadal older men with physical frailty, whether six months of exercise training combined with testosterone replacement therapy can improve physical function, bone mineral density, and quality of life, to a greater degree than six months of exercise training alone.
Comparison: Men age 65 years and older who meet criteria for physical frailty and have a serum testosterone level below 350 ng/dl are randomly assigned to one of two groups: 1) transdermal testosterone replacement therapy + supervised exercise training for six months vs. 2) inactive placebo gel + supervised exercise training for six months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Isokinetic Leg Extension Torque at 0 Deg/Sec | Leg Extension Torque measured with Cybex dynamometer at 0 deg/sec | Baseline and Six Months |
| Change in Leg Extension Torque at 60 Deg/Sec |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Serum Prostate Specific Antigen (PSA) Level | Baseline and Six Months | |
| Change in Hematocrit | Percentage of the volume of whole blood composed of Red Blood Cells | Baseline and Six Months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ellen F. Binder, MD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
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Participants were carefully screened for exclusion criteria prior to randomization.
Participants were recruited from orthopedic units of local hospitals, rehabilitation facilities (both acute rehabilitation units and SNFs), home care programs, and the community-at-large.
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| ID | Title | Description |
|---|---|---|
| FG000 | Exercise + Placebo | Participants assigned to this group were prescribed an inactive topical gel for 6 months, and also performed a supervised exercise training program three times per week for 6 months. |
| FG001 | Exercise + Testosterone | Participants assigned to this group were prescribed transdermal testosterone (Androgel 1%) for six months, and performed a supervised exercise training program three times per week for six months. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Men who completed the intervention and provided baseline and follow-up data for primary outcome measures.
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| ID | Title | Description |
|---|---|---|
| BG000 | Exercise + Placebo | Participants assigned to this group were prescribed an inactive topical gel for 6 months, and also performed a supervised exercise training program three times per week for 6 months. |
| BG001 | Exercise + Testosterone |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Change in Total Lean Body Mass | Total Lean Mass measured by Dual X-ray Absorptiometry (DXA) | Posted | Mean | Standard Deviation | kg | Baseline and Six Months |
|
12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Exercise + Placebo | Participants assigned to this group were prescribed an inactive topical gel for 6 months, and also performed a supervised exercise training program three times per week for 6 months. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | Non-systematic Assessment | Participant experienced new onset atrial fibrillation that required acute care hospitalization. The patient's symptoms occurred at rest and were not coincident with performing exercise. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Elevated serum PSA level | Renal and urinary disorders | Systematic Assessment | Participant had elevated PSA level (7.2 ng/mL) at month 6 of study, which returned to normal at 30-day follow up. |
Small number of subjects enrolled, single site trial, included both hip fracture patients and a few patients with elective hip joint replacement.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ellen F. Binder, MD | Washington University School of Medicine | 314-286-2707 | ebinder@wustl.edu |
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| ID | Term |
|---|---|
| D006620 | Hip Fractures |
| D007006 | Hypogonadism |
| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
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| ID | Term |
|---|---|
| D013739 | Testosterone |
| ID | Term |
|---|---|
| D000737 | Androstenols |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 |
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|
| 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. |
|
Leg Extension Torque measured with Cybex dynamometry at 60 deg/sec
| Baseline and Six Months |
| Change in Total Body Fat Mass | Total Body Fat Mass as measured by DXA | Baseline and Six Months |
| Change in Femoral Bone Mineral Density (BMD) | Femoral Bone Mineral Density measured with Dual X-ray Absorptiometry (DXA) | Baseline and Six Months |
| Change in Total Modified Physical Performance (mPPT) Score | The Modified Physical Performance Test (mPPT) is a direct observational test that assesses multiple dimensions of physical function (basic and complex activities of daily living [ADL]) with different levels of difficulty. The test consists of 9 performance tasks. The total score range is 0-36 (min-max), with higher scores indicating better performance. Sub-scores are assigned for each of 9 item tasks; sub-score range is 0-4 (min-max) with higher scores indicating better performance. The sub-scores are summed to compute the total score. | Baseline and Six Months |
| Change in Serum Testosterone Level | Total Serum Testosterone Level (ng/mL) | Baseline and Six Months |
| Change in Serum Total Cholesterol Level | Baseline and Six Months |
| Change in Serum HDL Cholesterol Level | Baseline and Six Months |
| Change in Serum LDL Cholesterol Level | Baseline and Six Months |
Participants assigned to this group were prescribed transdermal testosterone (Androgel 1%) for six months, and performed a supervised exercise training program three times per week for six months. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Total Modified Physical Performance (mPPT) score | Range 0-36, (min-max); higher scores indicate better physical performance. The Total mPPT score is constructed by summing sub-scores of 9 performance tasks. Sub-scores have a range of 0-4 (min-max); higher sub-scores indicate better performance. | Mean | Standard Deviation | units on a scale |
|
| Total Testosterone level (ng/dL) | Mean | Standard Deviation | ng/dL |
|
| BMI (kg/m2) | Mean | Standard Deviation | kg/m2 |
|
| Body Weight (lbs.) | Mean | Standard Deviation | lbs. |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Primary | Change in Skeletal Muscle Strength by 1-RM | One-repetition maximum strength for leg extension | Only 8 participants in the Exercise+Testosterone group provided Leg Extension 1-RM measurements at baseline and 6-month follow-up. | Posted | Mean | Standard Deviation | lbs. | Baseline and Six Months |
|
|
|
|
| Secondary | Change in Isokinetic Leg Extension Torque at 0 Deg/Sec | Leg Extension Torque measured with Cybex dynamometer at 0 deg/sec | Only 10 participants in Exercise+Placebo group, and 8 participants in Exercise+Testosterone group, provided Leg Extension torque measurements at baseline and 6-month follow-up. | Posted | Mean | Standard Deviation | ft/lb | Baseline and Six Months |
|
|
|
|
| Secondary | Change in Leg Extension Torque at 60 Deg/Sec | Leg Extension Torque measured with Cybex dynamometry at 60 deg/sec | Only 10 participants in the Exercise+Placebo group, and 8 participants in the Exercise+Testosterone group, provided Leg extension torque measurements at baseline and 6 month follow-up. | Posted | Mean | Standard Deviation | ft/lb | Baseline and Six Months |
|
|
|
|
| Secondary | Change in Total Body Fat Mass | Total Body Fat Mass as measured by DXA | Posted | Mean | Standard Deviation | kg | Baseline and Six Months |
|
|
|
|
| Secondary | Change in Femoral Bone Mineral Density (BMD) | Femoral Bone Mineral Density measured with Dual X-ray Absorptiometry (DXA) | Only 10 participants in the Exercise+Placebo group, and 10 participants in the Exercise+Testosterone group, provided femoral bone density measurements at baseline and the 6 month follow-up. | Posted | Mean | Standard Deviation | g/cm2 | Baseline and Six Months |
|
|
|
|
| Secondary | Change in Total Modified Physical Performance (mPPT) Score | The Modified Physical Performance Test (mPPT) is a direct observational test that assesses multiple dimensions of physical function (basic and complex activities of daily living [ADL]) with different levels of difficulty. The test consists of 9 performance tasks. The total score range is 0-36 (min-max), with higher scores indicating better performance. Sub-scores are assigned for each of 9 item tasks; sub-score range is 0-4 (min-max) with higher scores indicating better performance. The sub-scores are summed to compute the total score. | Only 10 participants in the Exercise+Placebo group, and 9 participants in the Exercise+Testosterone group, provided baseline and follow-up mPPT measurements. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Six Months |
|
|
|
|
| Other Pre-specified | Change in Serum Prostate Specific Antigen (PSA) Level | Only 10 participants in the Exercise+Placebo group, and 9 participants in the Exercise+Testosterone group, provided serum PSA level measurements at baseline and 6 month follow-up. | Posted | Mean | Standard Deviation | ng/mL | Baseline and Six Months |
|
|
|
|
| Other Pre-specified | Change in Hematocrit | Percentage of the volume of whole blood composed of Red Blood Cells | Only 10 participants in the Exercise+Placebo group, and 9 participants in the Exercise+Testosterone group, provided hematocrit measurements at baseline and 6-month follow-up. | Posted | Mean | Standard Deviation | percent | Baseline and Six Months |
|
|
|
|
| Other Pre-specified | Change in Serum Total Cholesterol Level | Only 9 participants in the Exercise+Placebo group, and 9 participants in the Exercise+Testosterone group, provided serum for cholesterol measurements at baseline and 6 months. | Posted | Mean | Standard Deviation | mg/dL | Baseline and Six Months |
|
|
|
|
| Other Pre-specified | Change in Serum HDL Cholesterol Level | Only 9 participants in the Exercise+Placebo group, and 9 participants in the Exercise+Testosterone group, provided serum for HDL cholesterol measurements at baseline and 6 months. | Posted | Mean | Standard Deviation | mg/dL | Baseline and Six Months |
|
|
|
|
| Other Pre-specified | Change in Serum LDL Cholesterol Level | Only 9 participants in the Exercise+Placebo group, and 9 participants in the Exercise+Testosterone group, provided serum for LDL cholesterol measurements at baseline and 6 months. | Posted | Mean | Standard Deviation | mg/dL | Baseline and Six Months |
|
|
|
|
| Secondary | Change in Serum Testosterone Level | Total Serum Testosterone Level (ng/mL) | Only 9 participants in the Exercise+Testosterone group provided serum testosterone levels at baseline and 6-month follow-up. | Posted | Mean | Standard Deviation | ng/mL | Baseline and Six Months |
|
|
|
|
| 0 |
| 12 |
| 1 |
| 12 |
| EG001 | Exercise + Testosterone | Participants assigned to this group were prescribed transdermal testosterone (Androgel 1%) for six months, and performed a supervised exercise training program three times per week for six months. | 1 | 13 | 1 | 13 |
|
|
| Fall | General disorders | Non-systematic Assessment | Participant experienced a fall during balance testing; no injury sustained. |
|
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| D007869 |
| Leg Injuries |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045165 | Testosterone Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |