Osteoporosis Clinical Trial
Official title:
Testosterone and Alendronate in Hypogonadal Men
NCT number | NCT01460654 |
Other study ID # | MGH-988 |
Secondary ID | |
Status | Terminated |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | October 2011 |
Est. completion date | December 2014 |
Verified date | October 2023 |
Source | Massachusetts General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 44 |
Est. completion date | December 2014 |
Est. primary completion date | May 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 60 Years to 85 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Massachusetts General Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Massachusetts General Hospital | Endo Pharmaceuticals, Merck Sharp & Dohme LLC |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percent Change in Spine Bone Density From Baseline to 12 Months | Percent Change in Spine Bone Density from Baseline (month 0) to Month 12 | Baseline and 12 months |
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