Testosterone and Alendronate in Hypogonadal Men

Sponsor

Massachusetts General Hospital (Other)

Overall Status

Terminated

CT.gov ID

NCT01460654

Collaborator

Endo Pharmaceuticals (Industry), Merck Sharp & Dohme LLC (Industry)

Enrollment

Location

Arms

Duration (Months)

1.2

Patients Per Site Per Month

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
Hypogonadism Osteopenia Osteoporosis	Drug: Testosterone Drug: Alendronate Drug: Placebo Alendronate Drug: Placebo Testosterone	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

44 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Testosterone and Alendronate in Hypogonadal Men

Study Start Date :

Oct 1, 2011

Actual Primary Completion Date :

May 1, 2014

Actual Study Completion Date :

Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Testosterone and Placebo Alendronate	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.
Placebo Comparator: Alendronate and Placebo Testosterone	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.
Experimental: Testosterone and Alendronate	Drug: Testosterone Testosterone Gel (Fortesta) 40mg daily. Drug: Alendronate Alendronate (Fosamax) 70mg every week.

Arm

Intervention/Treatment

Placebo Comparator: Testosterone and Placebo Alendronate

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.

Placebo Comparator: Alendronate and Placebo Testosterone

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.

Experimental: Testosterone and Alendronate

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

Ages Eligible for Study:

60 Years to 85 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Male sex
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