NCT01460654
Terminated
Phase 2
Testosterone and Alendronate in Hypogonadal Men
Overview
- Phase
- Phase 2
- Intervention
- Testosterone
- Conditions
- Hypogonadism
- Sponsor
- Massachusetts General Hospital
- Enrollment
- 44
- Locations
- 1
- Primary Endpoint
- Percent Change in Spine Bone Density From Baseline to 12 Months
- Status
- Terminated
- Last Updated
- 2 years ago
Overview
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.
Investigators
Benjamin Leder, MD
Associate Professor of Medicine
Massachusetts General Hospital
Eligibility Criteria
Inclusion Criteria
- •Age 60 or above
- •Testosterone \<300 ng/dL
- •DXA T score \< -1 OR FRAX Score of 3% or greater for hip fracture or 20% or greater for major osteoporotic fracture
Exclusion Criteria
- •Significant liver or kidney disease
- •Elevated prolactin level
- •Abnormal TSH
- •Abnormal 25-Vitamin D
- •PSA \> 2.5
- •History of malignancy
- •Calcium \> 10.6
- •Alkaline Phosphatase \> 150
- •Fracture within the last 6 months
- •History of acute urinary retention
Arms & Interventions
Testosterone and Placebo Alendronate
Intervention: Testosterone
Testosterone and Placebo Alendronate
Intervention: Placebo Alendronate
Alendronate and Placebo Testosterone
Intervention: Alendronate
Alendronate and Placebo Testosterone
Intervention: Placebo Testosterone
Testosterone and Alendronate
Intervention: Testosterone
Testosterone and Alendronate
Intervention: Alendronate
Outcomes
Primary Outcomes
Percent Change in Spine Bone Density From Baseline to 12 Months
Time Frame: Baseline and 12 months
Percent Change in Spine Bone Density from Baseline (month 0) to Month 12
Study Sites (1)
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