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What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Hypogonadism

Osteopenia

Osteoporosis

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:TestosteroneTestosterone Gel (Fortesta) 40mg daily.

Drug:AlendronateAlendronate (Fosamax) 70mg every week.

Drug:Placebo AlendronateA placebo alendronate tablet will be taken every week by subjects in the Testosterone and Placebo Alendronate Group.

Drug:Placebo TestosteronePlacebo testosterone gel will be applied daily by subjects in the Alendronate and Placebo Testosterone group.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Testosterone and Placebo Alendronate

Alendronate and Placebo Testosterone

Testosterone and Alendronate

Study Status

Suspended

Start Date: October 2011

Completed Date: June 2019

Phase: Phase 2

Type: Interventional

Design:

Primary Outcome: Spine Bone Mineral Density by DXA

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator:

Lead Sponsor: Massachusetts General Hospital

Collaborator: Endo Pharmaceuticals

More information:https://clinicaltrials.gov/show/NCT01460654