Testosterone and Alendronate in Hypogonadal Men

• Status: Suspended
• Trial end date: 2019-06-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Massachusetts General Hospital
• Collaborators: Endo Pharmaceuticals; Merck Sharp & Dohme Corp.
• Treatments: Alendronate; Methyltestosterone; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

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