Testosterone and Alendronate in Hypogonadal Men

Massachusetts General Hospital (Other)
Overall Status
CT.gov ID
Endo Pharmaceuticals (Industry), Merck Sharp & Dohme LLC (Industry)

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
Phase 2

Study Design

Study Type:
Actual Enrollment :
44 participants
Intervention Model:
Parallel Assignment
Single (Participant)
Primary Purpose:
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.

Outcome Measures

Primary Outcome Measures

  1. Spine Bone Mineral Density by DXA [12 months]

Eligibility Criteria


Ages Eligible for Study:
60 Years to 85 Years
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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

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

  • Hematocrit < 32% or > 50%

  • Fracture within the past 6 months

  • American Urological Association BPH symptom index > 21

  • Sleep apnea

  • Abnormalities of the esophagus which delay esophageal emptying

  • Significant cardiopulmonary disease

Contacts and 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


None specified.

Study Documents (Full-Text)

None provided.

More Information


None provided.
Responsible Party:
Benjamin Leder, MD, Associate Professor of Medicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
Other Study ID Numbers:
  • MGH-988
First Posted:
Oct 27, 2011
Last Update Posted:
Aug 18, 2022
Last Verified:
Aug 1, 2022

Study Results

No Results Posted as of Aug 18, 2022