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Testosterone and Alendronate in Hypogonadal Men

NCT01460654 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2023-10-12

Study results available
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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.

Conditions

Interventions

DRUG

Testosterone

Testosterone Gel (Fortesta) 40mg daily.

DRUG

Alendronate

Alendronate (Fosamax) 70mg every week.

DRUG

Placebo Alendronate

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

DRUG

Placebo Testosterone

Placebo testosterone gel will be applied daily by subjects in the Alendronate and Placebo Testosterone group.

Sponsors & Collaborators

  • Endo Pharmaceuticals

    collaborator INDUSTRY

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • Massachusetts General Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
85 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2014-05-31
Completion
2014-12-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01460654 on ClinicalTrials.gov