Testosterone and Alendronate in Hypogonadal Men

Phase 2TerminatedNCT01460654

Massachusetts General Hospital44 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Hypogonadism Osteopenia Osteoporosis

Interventions

TestosteroneDRUG

Testosterone Gel (Fortesta) 40mg daily.

AlendronateDRUG

Alendronate (Fosamax) 70mg every week.

Placebo AlendronateDRUG

A placebo alendronate tablet will be taken every week by subjects in the Testosterone and Placebo Alendronate Group.

Eligibility

Sex: MALEMin age: 60 YearsMax age: 85 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Massachusetts General Hospital

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Percent Change in Spine Bone Density From Baseline to 12 Months

Percent Change in Spine Bone Density from Baseline (month 0) to Month 12

Time frame: Baseline and 12 months

Data from ClinicalTrials.gov

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