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NCT01460654 Clinical Trial

Testosterone and Alendronate in Hypogonadal Men

Osteoporosis Clinical Trial

Official title:
Testosterone and Alendronate in Hypogonadal Men

Clinical Trial Details — Status: Terminated

Administrative data
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

Study information
Verified date October 2023
Source Massachusetts General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Testosterone
Testosterone Gel (Fortesta) 40mg daily.
• Alendronate
Alendronate (Fosamax) 70mg every week.
• Placebo Alendronate
A placebo alendronate tablet will be taken every week by subjects in the Testosterone and Placebo Alendronate Group.
• Placebo Testosterone
Placebo testosterone gel will be applied daily by subjects in the Alendronate and Placebo Testosterone group.

Locations
Country Name City State
United States Massachusetts General Hospital Boston Massachusetts

Sponsors (3)
Lead Sponsor Collaborator
Massachusetts General Hospital Endo Pharmaceuticals, Merck Sharp & Dohme LLC

Country where clinical trial is conducted

United States, 

Outcome
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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