Testosterone and Alendronate in Hypogonadal Men

Phase 2

Terminated

• Conditions: Hypogonadism; Osteopenia; Osteoporosis
• Interventions: Drug: Testosterone; Drug: Alendronate; Drug: Placebo Alendronate; Drug: Placebo Testosterone

• Registration Number: NCT01460654
• Lead Sponsor: Massachusetts General Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2011-10-20
• Study First Submitted QC: 2011-10-25
• Study First Posted: 2011-10-27
• Primary Completion: 2014-05
• Study Completion: 2014-12
• Results First Submitted: 2023-09-06
• Status Verified: 2023-10
• Results First Submitted QC: 2023-10-10
• Last Update Submitted: 2023-10-10
• Results First Posted: 2023-10-12
• Last Update Posted: 2023-10-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 44

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Testosterone and Placebo Alendronate	Placebo Alendronate	-
Alendronate and Placebo Testosterone	Placebo Testosterone	-
Testosterone and Placebo Alendronate	Testosterone	-
Alendronate and Placebo Testosterone	Alendronate	-
Testosterone and Alendronate	Testosterone	-
Testosterone and Alendronate	Alendronate	-

Primary Outcome Measures

Name	Time	Method
Percent Change in Spine Bone Density From Baseline to 12 Months	Baseline and 12 months	Percent Change in Spine Bone Density from Baseline (month 0) to Month 12

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States