Testosterone and Alendronate in Hypogonadal Men

Mass General Brigham

Status and phase: Terminated; Phase 2

Conditions: Osteoporosis; Osteopenia; Hypogonadism

Treatments: Drug: Placebo Testosterone; Drug: Placebo Alendronate; Drug: Testosterone; Drug: Alendronate

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01460654

MGH-988

Details and patient eligibility

About

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.

Enrollment: 44 patients

Sex: Male

Ages: 60 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

44 participants in 3 patient groups, including a placebo group

Testosterone and Placebo Alendronate

Placebo Comparator group

Treatment:

Drug: Testosterone

Drug: Placebo Alendronate

Alendronate and Placebo Testosterone

Placebo Comparator group

Treatment:

Drug: Placebo Testosterone

Drug: Alendronate

Testosterone and Alendronate

Experimental group

Treatment:

Drug: Testosterone

Drug: Alendronate