Testosterone and Alendronate in Hypogonadal Men
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
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Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Placebo Comparator: Testosterone and Placebo Alendronate
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Drug: Testosterone
Testosterone Gel (Fortesta) 40mg daily.
Drug: Placebo Alendronate
A placebo alendronate tablet will be taken every week by subjects in the Testosterone and Placebo Alendronate Group.
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Placebo Comparator: Alendronate and Placebo Testosterone
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Drug: Alendronate
Alendronate (Fosamax) 70mg every week.
Drug: Placebo Testosterone
Placebo testosterone gel will be applied daily by subjects in the Alendronate and Placebo Testosterone group.
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Experimental: Testosterone and Alendronate
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Drug: Testosterone
Testosterone Gel (Fortesta) 40mg daily.
Drug: Alendronate
Alendronate (Fosamax) 70mg every week.
|
Outcome Measures
Primary Outcome Measures
- Spine Bone Mineral Density by DXA [12 months]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male sex
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Age 60 or above
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Testosterone <300 ng/dL
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DXA T score < -1 OR FRAX Score of 3% or greater for hip fracture or 20% or greater for major osteoporotic fracture
Exclusion Criteria:
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Significant liver or kidney disease
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Elevated prolactin level
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Abnormal TSH
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Abnormal 25-Vitamin D
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PSA > 2.5
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History of malignancy
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Calcium > 10.6
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Alkaline Phosphatase > 150
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Fracture within the last 6 months
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History of acute urinary retention
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Hematocrit < 32% or > 50%
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Fracture within the past 6 months
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American Urological Association BPH symptom index > 21
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Sleep apnea
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Abnormalities of the esophagus which delay esophageal emptying
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Significant cardiopulmonary disease
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Massachusetts General Hospital | Boston | Massachusetts | United States | 02114 |
Sponsors and Collaborators
- Massachusetts General Hospital
- Endo Pharmaceuticals
- Merck Sharp & Dohme LLC
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MGH-988