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| ID | Type | Description | Link |
|---|---|---|---|
| R01AG019339 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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The purpose of this study is to evaluate the effects of testosterone supplementation (AndroGel) on body composition, strength, endurance, cognition, and function in older men.
Studies suggest that testosterone (T) replacement in healthy elderly men has beneficial effects on body composition, muscle, bone, memory, and behavior, but the risks of chronic treatment, especially on the prostate, heart, and sleep quality, are not entirely clear. Therefore, it is most desirable to supplement into the lowest "effective" range in elderly men. However, the effects of lower than usual replacement T doses have not been well studied. Furthermore, the possible important interaction of exercise to enhance the positive effects of T supplementation, yet mitigate the possible side effects, has not been studied in older men.
This one-year study will enroll 150 men with low-normal to slightly below normal serum total T levels. Participants will be randomized into one of 6 treatment groups to receive T supplementation (AndroGel) of 25mg/day, 50 mg/day or a placebo crossed with progressive resistance training (PRT) exercise 3 times a week versus none. At the end of the study, participants in the exercise-control group will be offered PRT.
Please see link below for updated version of full protocol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LowT+Resistance Training | Experimental | Low Dose Testosterone Group applies one 2.5 gm active packet and one placebo packet, titrated to a target blood range of 400-550 pg/ml) 1 year standard Progressive Resistance Training(PRT) program |
|
| LowT+No Resistance training | Experimental | Low Dose Testosterone Group applies one 2.5 gm active packet and one placebo packet, titrated to a target blood range of 400-550 pg/ml) No exercise program |
|
| HighT+Resistance Training | Experimental | High Dose Testosterone Group applies two 2.5 gm active packets, titrated to a target blood range of 600-1000 pg/ml) 1 year standard Progressive Resistance Training(PRT) program |
|
| HighT+No Resistance Training | Experimental | High Dose Testosterone Group applies two 2.5 gm active packets, titrated to a target blood range of 600-1000 pg/ml) No exercise program |
|
| Placebo+Resistance Training | Active Comparator | Placebo Group applies two 2.5 gm placebo packets 1 year standard Progressive Resistance Training(PRT) program |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LowT | Drug | Low Dose Testosterone Group applies one 2.5 gm active packet and one placebo packet, titrated to a target blood range of 400-550 pg/ml)during the first 12 weeks. Total exposure duration is 52 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Physical Function (CS-PFP Total Score) | Continuous-scale physical function performance test (CS-PFP) which comprises 15 everyday tasks requiring upper and lower body strength and flexibility, balance, coordination and endurance. The CS-PFP was developed to measure performance in higher functioning adults with minimal floor or ceiling effects, and is valid, reliable and sensitive to change. Total and domain scores are scaled from 0 to 100, with higher scores indicating better function. | Baseline and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Upper Body Muscle Strength (1-RM, kg) | The maximal weight a participant could lift once (1-repetition maximum, 1-RM) was assessed at baseline and 12 months. The average of the difference from baseline in 4 upper-body 1-RM measures (bench press,incline press, overhead pull-down, and seated row) are represented. | Baseline and 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert S. Schwartz, MD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Health Sciences Center | Denver | Colorado | 80262 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 2229940 | Background | Schwartz RS, Shuman WP, Bradbury VL, Cain KC, Fellingham GW, Beard JC, Kahn SE, Stratton JR, Cerqueira MD, Abrass IB. Body fat distribution in healthy young and older men. J Gerontol. 1990 Nov;45(6):M181-5. doi: 10.1093/geronj/45.6.m181. | |
| 7552755 | Background | Porter MM, Vandervoort AA, Lexell J. Aging of human muscle: structure, function and adaptability. Scand J Med Sci Sports. 1995 Jun;5(3):129-42. doi: 10.1111/j.1600-0838.1995.tb00026.x. |
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see eligibility criteria
Recruitment from January 2005 through August 2009 of community dwelling men >=60 years of age in the Denver metropolitan area with active attempts to recruit men from all ethnic populations.
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| ID | Title | Description |
|---|---|---|
| FG000 | LowT+Resistance Training | Low Dose Testosterone Group applies one 2.5 gm active packet and one placebo packet, titrated to a target blood range of 400-550 pg/ml) 1 year standard Progressive Resistance Training(PRT) program |
| FG001 | LowT+No Resistance Training | Low Dose Testosterone Group applies one 2.5 gm active packet and one placebo packet, titrated to a target blood range of 400-550 pg/ml) No exercise program |
| FG002 | HighT+Resistance Training | High Dose Testosterone Group applies two 2.5 gm active packets, titrated to a target blood range of 600-1000 pg/ml) 1 year standard Progressive Resistance Training(PRT) program |
| FG003 | HighT+No Resistance Training | High Dose Testosterone Group applies two 2.5 gm active packets, titrated to a target blood range of 600-1000 pg/ml) No exercise program |
| FG004 | Placebo+Resistance Training | Placebo Group applies two 2.5 gm placebo packets 1 year standard Progressive Resistance Training(PRT) program |
| FG005 | Placebo+No Resistance Training | Placebo group applies two 2.5 gm placebo packets No exercise program |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | LowT+Resistance Training | Low Dose Testosterone Group applies one 2.5 gm active packet and one placebo packet, titrated to a target blood range of 400-550 pg/ml) 1 year standard Progressive Resistance Training(PRT) program |
| BG001 | LowT+No Resistance Training |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Physical Function (CS-PFP Total Score) | Continuous-scale physical function performance test (CS-PFP) which comprises 15 everyday tasks requiring upper and lower body strength and flexibility, balance, coordination and endurance. The CS-PFP was developed to measure performance in higher functioning adults with minimal floor or ceiling effects, and is valid, reliable and sensitive to change. Total and domain scores are scaled from 0 to 100, with higher scores indicating better function. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 12 months |
|
1 year
Systematic assessments were done at baseline, 4, 12, 26 and 52 weeks. As prespecified, adverse events were analyzed according to T dosing (e.g. placebo, lower-range T, and higher-range T).
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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 | Placebo | Placebo gel with or without progressive resistance training |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Total serious cardiovascular adverse events | Cardiac disorders | Non-systematic Assessment | Includes acute coronary syndrome, arrhythmia, aortic aneurysm, syncope/presyncope |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Persistently elevated HCT >= 54% | Blood and lymphatic system disorders | Systematic Assessment | Polycythemia or persistent elevated hematocrit >= 54% |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Robert S. Schwartz, Head, Division of Geriatric Medicine | Univeristy of Colorado at Denver | 303-724-1919 | robert.schwartz@ucdenver.edu |
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| ID | Term |
|---|---|
| D007006 | Hypogonadism |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D013739 | Testosterone |
| D055070 | Resistance Training |
| ID | Term |
|---|---|
| D000737 | Androstenols |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 |
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|
| Placebo+No Resistance Training | Placebo Comparator | Placebo group applies two 2.5 gm placebo packets No exercise program |
|
|
| Resistance Training | Behavioral | Weight training 45-60 minutes 3 times per week |
|
|
| Placebo | Drug | 2.5 gm gel packets applied once daily. Sham adjustments made during the first 12 weeks. Duration is 52 weeks. |
|
| HighT | Drug | High Dose Testosterone Group applies two 2.5 gm active packets, titrated to a target blood range of 600-1000 pg/ml)during the first 12 weeks. Total exposure duration is 52 weeks. |
|
|
| Lower Body Muscle Strength (1-RM, kg) |
The maximal weight a participant could lift once [1-repetition maximum, 1-RM] was assessed at baseline and 12 months. The average of the difference from baseline in 3 lower-body 1-RM measures (knee extension, knee flexion, and seated leg press)) are represented. |
| Baseline and 12 months |
| Power (Power Rig, Watts) | Leg extensor power was evaluated using a Nottingham leg extensor power rig (watts). | Baseline and 12 months |
| Fat Mass (kg) | Total change in Fat mass (kg) as evaluated by DXA | Baseline and 12 months |
| Fat Free Mass (kg) | Total change in Fat free mass (kg) as evaluated by DXA | Baseline and 12 months |
| 8601053 | Background | Jolles J, Verhey FR, Riedel WJ, Houx PJ. Cognitive impairment in elderly people. Predisposing factors and implications for experimental drug studies. Drugs Aging. 1995 Dec;7(6):459-79. doi: 10.2165/00002512-199507060-00006. |
| 6602143 | Background | Davidson JM, Chen JJ, Crapo L, Gray GD, Greenleaf WJ, Catania JA. Hormonal changes and sexual function in aging men. J Clin Endocrinol Metab. 1983 Jul;57(1):71-7. doi: 10.1210/jcem-57-1-71. |
| 9224429 | Background | Vitiello MV. Sleep disorders and aging: understanding the causes. J Gerontol A Biol Sci Med Sci. 1997 Jul;52(4):M189-91. doi: 10.1093/gerona/52a.4.m189. No abstract available. |
| 8684716 | Background | Myers BL, Badia P. Changes in circadian rhythms and sleep quality with aging: mechanisms and interventions. Neurosci Biobehav Rev. 1995 Winter;19(4):553-71. doi: 10.1016/0149-7634(95)00018-6. |
Low Dose Testosterone Group applies one 2.5 gm active packet and one placebo packet, titrated to a target blood range of 400-550 pg/ml) No exercise program |
| BG002 | HighT+Resistance Training | High Dose Testosterone Group applies two 2.5 gm active packets, titrated to a target blood range of 600-1000 pg/ml) 1 year standard Progressive Resistance Training(PRT) program |
| BG003 | HighT+No Resistance Training | High Dose Testosterone Group applies two 2.5 gm active packets, titrated to a target blood range of 600-1000 pg/ml) No exercise program |
| BG004 | Placebo+Resistance Training | Placebo Group applies two 2.5 gm placebo packets 1 year standard Progressive Resistance Training(PRT) program |
| BG005 | Placebo+No Resistance Training | Placebo group applies two 2.5 gm placebo packets No exercise program |
| BG006 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Any T + No PRT | T gel supplementation (lower or higher-range); no exercise |
| OG003 | Any T + PRT | T gel supplementation (lower or higher-range) plus progressive resistance training |
|
|
|
| Secondary | Upper Body Muscle Strength (1-RM, kg) | The maximal weight a participant could lift once (1-repetition maximum, 1-RM) was assessed at baseline and 12 months. The average of the difference from baseline in 4 upper-body 1-RM measures (bench press,incline press, overhead pull-down, and seated row) are represented. | Posted | Mean | Standard Deviation | kg | Baseline and 12 months |
|
|
|
|
| Secondary | Lower Body Muscle Strength (1-RM, kg) | The maximal weight a participant could lift once [1-repetition maximum, 1-RM] was assessed at baseline and 12 months. The average of the difference from baseline in 3 lower-body 1-RM measures (knee extension, knee flexion, and seated leg press)) are represented. | Posted | Mean | Standard Deviation | kg | Baseline and 12 months |
|
|
|
|
| Secondary | Power (Power Rig, Watts) | Leg extensor power was evaluated using a Nottingham leg extensor power rig (watts). | Posted | Mean | Standard Deviation | Watts | Baseline and 12 months |
|
|
|
|
| Secondary | Fat Mass (kg) | Total change in Fat mass (kg) as evaluated by DXA | Posted | Mean | Standard Deviation | kg | Baseline and 12 months |
|
|
|
|
| Secondary | Fat Free Mass (kg) | Total change in Fat free mass (kg) as evaluated by DXA | Posted | Mean | Standard Deviation | kg | Baseline and 12 months |
|
|
|
|
| 30 |
| 47 |
| 23 |
| 47 |
| EG001 | Lower-range T | T gel supplementation targeting a total serum T concentration of 400-550ng/dL, with our without progressive resistance training | 33 | 47 | 14 | 47 |
| EG002 | Higher-range T | T gel supplementation targeting a total serum T concentration of 600-1000ng/dL, with our without progressive resistance training | 38 | 49 | 25 | 49 |
|
| Other noncardiovascular serious adverse events | General disorders | Non-systematic Assessment |
|
|
| Persistently elevated PSA | Renal and urinary disorders | Systematic Assessment | Persistent elevated PSA representing an increase of >=0.75 ng/mL over baseline |
|
| Elevated AUA | Renal and urinary disorders | Systematic Assessment | American Urological Association (AUA) BPH Symptom Score Index >= 20 |
|
| Persistently elevated liver function tests | Hepatobiliary disorders | Systematic Assessment | Alanine aminotransferase or aspartate aminotransferase > 2 times the upper limit of normal |
|
| Daytime somnolence/hypoxia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Somnolence = Epworth Sleepiness Score > 16; hypoxia is daytime arterial oxygen saturation by pulse oximetry < 88% |
|
| Other nonserious adverse events | General disorders | Non-systematic Assessment | Other nonserious adverse events |
|
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| 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 |
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
As prespecified, the lower- and higher-range T groups were combined (Any T). The analysis compared change from baseline to 12 months in average upper body strength with any T to placebo in subjects assigned to no PRT.
| Regression, Linear |
| <0.05 |
| 2-Sided |
| Superiority or Other (legacy) |
As prespecified, the lower- and higher-range T groups were combined (Any T). The analysis compared change from baseline to 12 months in average lower body strength with any T to placebo in subjects assigned to no PRT.
| Regression, Linear |
| <0.05 |
| 2-Sided |
| Superiority or Other (legacy) |
As prespecified, the lower- and higher-range T groups were combined (Any T). The analysis compared change from baseline to 12 months in leg extensor power with any T to placebo in subjects assigned to no PRT.
| Regression, Linear |
| <0.05 |
| 2-Sided |
| Superiority or Other (legacy) |
As prespecified, the lower- and higher-range T groups were combined (Any T). The analysis compared change from baseline to 12 months in fat mass measured by dual x-ray absorptiometry (DXA) with any T to placebo in subjects assigned to no PRT. |
| Regression, Linear |
| <0.05 |
| 2-Sided |
| Superiority or Other (legacy) |
As prespecified, the lower- and higher-range T groups were combined (Any T). The analysis compared change from baseline to 12 months in fat free mass measured by dual x-ray absorptiometry (DXA) with any T to placebo in subjects assigned to no PRT. |
| Regression, Linear |
| <0.05 |
| 2-Sided |
| Superiority or Other (legacy) |