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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01AG025099-05 | U.S. NIH Grant/Contract | View source | |
| 1R01AG025099-1A1 |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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The purpose of the study is to assess the effects of sustained aromatase inhibitor therapy to reduce estrogen levels in elderly men with mild hypogonadism (a decreased level of sex hormones).
It has long been accepted that aging in men is associated with a slow, steady decline in gonadal androgen (male sex hormone) production. Several studies have explored androgen replacement, but the safety and efficacy of testosterone administration remains controversial. Aromatase inhibitors may provide a particularly useful way to restore normal androgen production in aging men.
This study will recruit 150 male volunteers, 60 years of age or older, to be randomized to receive either anastrozole or a placebo for 24 months. Six visits are planned over the 96-week treatment period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| anastrozole | Experimental | anastrozole |
|
| placebo | Placebo Comparator | placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| anastrozole | Drug | 1 mg QD |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Lean Body Mass | Baseline and 1 year |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Benjamin Z. Leder, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General Clinical Research Center, Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15001605 | Background | Leder BZ, Rohrer JL, Rubin SD, Gallo J, Longcope C. Effects of aromatase inhibition in elderly men with low or borderline-low serum testosterone levels. J Clin Endocrinol Metab. 2004 Mar;89(3):1174-80. doi: 10.1210/jc.2003-031467. | |
| 11397902 | Background | Taxel P, Kennedy DG, Fall PM, Willard AK, Clive JM, Raisz LG. The effect of aromatase inhibition on sex steroids, gonadotropins, and markers of bone turnover in older men. J Clin Endocrinol Metab. 2001 Jun;86(6):2869-74. doi: 10.1210/jcem.86.6.7541. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Anastrozole | anastrozole anastrozole: 1 mg QD |
| FG001 | Placebo | placebo anastrozole: 1 mg QD |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Anastrozole | anastrozole anastrozole: 1 mg QD |
| BG001 | Placebo | placebo anastrozole: 1 mg QD |
| 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 | Change in Lean Body Mass | Posted | Mean | Standard Deviation | grams | Baseline and 1 year |
|
|
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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 | Anastrozole | anastrozole anastrozole: 1 mg QD |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| prostate cancer | Renal and urinary disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| PSA increase | Renal and urinary disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Benjamin Leder | Massachusetts General Hospital | 617-726-6723 | bzleder@partners.org |
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| ID | Term |
|---|---|
| D007006 | Hypogonadism |
| ID | Term |
|---|---|
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000077384 | Anastrozole |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 |
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| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| 4 |
| 34 |
| 3 |
| 34 |
| EG001 | Placebo | placebo anastrozole: 1 mg QD | 1 | 35 | 3 | 35 |
| pancreatic cancer | Endocrine disorders |
|
| hepatitis A | Gastrointestinal disorders |
|
| pulmonary embolism | Blood and lymphatic system disorders |
|
| embolic stroke | Cardiac disorders |
|
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| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |