Testosterone and Alendronate in Hypogonadal Men
Information source: Massachusetts General Hospital
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypogonadism; Osteopenia; Osteoporosis
Intervention: Testosterone (Drug); Alendronate (Drug); Placebo Alendronate (Drug); Placebo Testosterone (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Massachusetts General Hospital Overall contact:
Alexander V Uihlein, MD, Phone: 617-643-9720, Email: auihlein@partners.org
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.
Clinical Details
Official title: Testosterone and Alendronate in Hypogonadal Men
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Primary outcome: Spine Bone Mineral Density by DXA
Eligibility
Minimum age: 60 Years.
Maximum age: 85 Years.
Gender(s): Male.
Criteria:
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
Locations and Contacts
Alexander V Uihlein, MD, Phone: 617-643-9720, Email: auihlein@partners.org
Massachusetts General Hospital, Boston, Massachusetts 02114, United States; Recruiting
Katelyn Foley, BA, Phone: 617-726-2860, Email: kfoley11@partners.org
Benjamin Z Leder, MD, Principal Investigator
Additional Information
Starting date: October 2011
Last updated: June 25, 2014
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