Testosterone and Alendronate in Hypogonadal Men
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01460654|
Recruitment Status : Suspended
First Posted : October 27, 2011
Last Update Posted : February 26, 2018
|Condition or disease||Intervention/treatment||Phase|
|Hypogonadism Osteopenia Osteoporosis||Drug: Testosterone Drug: Alendronate Drug: Placebo Alendronate Drug: Placebo Testosterone||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Testosterone and Alendronate in Hypogonadal Men|
|Study Start Date :||October 2011|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||June 2019|
|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: Testosterone and Alendronate||
Testosterone Gel (Fortesta) 40mg daily.Drug: Alendronate
Alendronate (Fosamax) 70mg every week.
- Spine Bone Mineral Density by DXA [ Time Frame: 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01460654
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|