Testosterone and Alendronate in Hypogonadal Men
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.
Drug: Placebo Alendronate
Drug: Placebo Testosterone
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||Testosterone and Alendronate in Hypogonadal Men|
- Spine Bone Mineral Density by DXA [ Time Frame: 12 months ] [ Designated as safety issue: No ]
|Study Start Date:||October 2011|
|Estimated Study Completion Date:||June 2015|
|Estimated Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
|Placebo Comparator: Testosterone and Placebo Alendronate||
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.
|Placebo Comparator: Alendronate and Placebo Testosterone||
Alendronate (Fosamax) 70mg every week.Drug: Placebo Testosterone
Placebo testosterone gel will be applied daily by subjects in the Alendronate and Placebo Testosterone group.
|Experimental: Tesosterone and Alendronate||
Testosterone Gel (Fortesta) 40mg daily.Drug: Alendronate
Alendronate (Fosamax) 70mg every week.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01460654
|Contact: Alexander V Uihlein, MDfirstname.lastname@example.org|
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Katelyn Foley, BA 617-726-2860 email@example.com|
|Principal Investigator: Benjamin Z Leder, MD|