Testosterone and Alendronate in Hypogonadal Men



Status:Suspended
Conditions:Osteoporosis, Endocrine, Gastrointestinal
Therapuetic Areas:Endocrinology, Gastroenterology, Rheumatology
Healthy:No
Age Range:60 - 85
Updated:12/2/2016
Start Date:October 2011
End Date:June 2017

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Trial Summary
Trial Overview
Inclusion Criteria
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.


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
We found this trial at
1
site
Massachusetts General Hospital
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Benjamin Z Leder, MD
Phone: 617-726-4650
?
mi
from
Boston, MA
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