Status:
TERMINATED
Testosterone and Alendronate in Hypogonadal Men
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Endo Pharmaceuticals
Merck Sharp & Dohme LLC
Conditions:
Hypogonadism
Osteopenia
Eligibility:
MALE
60-85 years
Phase:
PHASE2
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 i...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT01460654
Start Date
October 1 2011
End Date
December 1 2014
Last Update
October 12 2023
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114