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| Name | Class |
|---|---|
| Endo USA Inc., a Keenova Therapeutics Company | INDUSTRY |
| Merck Sharp & Dohme LLC | INDUSTRY |
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This study will investigate the hypothesis that the combination of testosterone replacement and alendronate will improve bone density and parameters of bone quality more than either medication alone in older men with low testosterone levels and low bone density.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Testosterone and Placebo Alendronate | Placebo Comparator |
| |
| Alendronate and Placebo Testosterone | Placebo Comparator |
| |
| Testosterone and Alendronate | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Testosterone | Drug | Testosterone Gel (Fortesta) 40mg daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Spine Bone Density From Baseline to 12 Months | Percent Change in Spine Bone Density from Baseline (month 0) to Month 12 | Baseline and 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Testosterone and Placebo Alendronate | Testosterone: Testosterone Gel (Fortesta) 40mg daily. Placebo Alendronate: A placebo alendronate tablet will be taken every week by subjects in the Testosterone and Placebo Alendronate Group. |
| FG001 | Alendronate and Placebo Testosterone | Alendronate: Alendronate (Fosamax) 70mg every week. Placebo Testosterone: Placebo testosterone gel will be applied daily by subjects in the Alendronate and Placebo Testosterone group. |
| FG002 | Testosterone and Alendronate | Testosterone: Testosterone Gel (Fortesta) 40mg daily. Alendronate: Alendronate (Fosamax) 70mg every week. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Testosterone and Placebo Alendronate | Testosterone: Testosterone Gel (Fortesta) 40mg daily. Placebo Alendronate: A placebo alendronate tablet will be taken every week by subjects in the Testosterone and Placebo Alendronate Group. |
| BG001 | Alendronate and Placebo Testosterone |
| 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 | Percent Change in Spine Bone Density From Baseline to 12 Months | Percent Change in Spine Bone Density from Baseline (month 0) to Month 12 | Posted | Mean | Standard Deviation | percent change of bone mineral density | Baseline and 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 | Testosterone and Placebo Alendronate | Testosterone: Testosterone Gel (Fortesta) 40mg daily. Placebo Alendronate: A placebo alendronate tablet will be taken every week by subjects in the Testosterone and Placebo Alendronate Group. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| nephrolithiasis | Renal and urinary disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| chest discomfort | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Benjamin Leder | Massachusetts General Hospital | 6177266723 | bzleder@partners.org |
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| ID | Term |
|---|---|
| D007006 | Hypogonadism |
| D001851 | Bone Diseases, Metabolic |
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D013739 | Testosterone |
| D019386 | Alendronate |
| ID | Term |
|---|---|
| D000737 | Androstenols |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 |
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| Alendronate | Drug | Alendronate (Fosamax) 70mg every week. |
|
| Placebo Alendronate | Drug | A placebo alendronate tablet will be taken every week by subjects in the Testosterone and Placebo Alendronate Group. |
|
| Placebo Testosterone | Drug | Placebo testosterone gel will be applied daily by subjects in the Alendronate and Placebo Testosterone group. |
|
Alendronate: Alendronate (Fosamax) 70mg every week. Placebo Testosterone: Placebo testosterone gel will be applied daily by subjects in the Alendronate and Placebo Testosterone group. |
| BG002 | Testosterone and Alendronate | Testosterone: Testosterone Gel (Fortesta) 40mg daily. Alendronate: Alendronate (Fosamax) 70mg every week. |
| BG003 | 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 | Testosterone and Alendronate | Testosterone: Testosterone Gel (Fortesta) 40mg daily. Alendronate: Alendronate (Fosamax) 70mg every week. |
|
|
| 2 |
| 19 |
| 13 |
| 19 |
| EG001 | Alendronate and Placebo Testosterone | Alendronate: Alendronate (Fosamax) 70mg every week. Placebo Testosterone: Placebo testosterone gel will be applied daily by subjects in the Alendronate and Placebo Testosterone group. | 1 | 10 | 8 | 10 |
| EG002 | Testosterone and Alendronate | Testosterone: Testosterone Gel (Fortesta) 40mg daily. Alendronate: Alendronate (Fosamax) 70mg every week. | 0 | 15 | 7 | 15 |
| bladder cancer | Renal and urinary disorders | Systematic Assessment |
|
| spinal stenosis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| dizziness | Nervous system disorders | Systematic Assessment |
|
| hypertension | Cardiac disorders | Systematic Assessment |
|
| glaucoma | Eye disorders | Systematic Assessment |
|
| Shingles | Infections and infestations | Systematic Assessment |
|
| Sinus surgery | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| upper respiratory infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| hypoglycemia | Endocrine disorders | Systematic Assessment |
|
| Elevated hematocrit | Blood and lymphatic system disorders | Systematic Assessment |
|
| Sciatic nerve pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| prostate nodule | Renal and urinary disorders | Systematic Assessment |
|
| hematuria | Renal and urinary disorders | Systematic Assessment |
|
| constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Elevated creatinine | Renal and urinary disorders | Systematic Assessment |
|
| Elevated prostrate screen antigen | Renal and urinary disorders | Systematic Assessment |
|
| Crohns disease | Gastrointestinal disorders | Systematic Assessment |
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| plantar fascitis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| muscle ache | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| achilles tendon tear | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
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| D008659 |
| Metabolic Diseases |
| D009750 | Nutritional and Metabolic 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 |
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |