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Testosterone and Alendronate in Hypogonadal Men

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01460654
Recruitment Status : Suspended
First Posted : October 27, 2011
Last Update Posted : December 1, 2016
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Hypogonadism Osteopenia Osteoporosis Drug: Testosterone Drug: Alendronate Drug: Placebo Alendronate Drug: Placebo Testosterone Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Testosterone and Alendronate in Hypogonadal Men
Study Start Date : October 2011
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Placebo Comparator: Testosterone and Placebo Alendronate Drug: Testosterone
Testosterone Gel (Fortesta) 40mg daily.
Drug: Placebo Alendronate
A placebo alendronate tablet will be taken every week by subjects in the Testosterone and Placebo Alendronate Group.
Placebo Comparator: Alendronate and Placebo Testosterone Drug: Alendronate
Alendronate (Fosamax) 70mg every week.
Drug: Placebo Testosterone
Placebo testosterone gel will be applied daily by subjects in the Alendronate and Placebo Testosterone group.
Experimental: Testosterone and Alendronate Drug: Testosterone
Testosterone Gel (Fortesta) 40mg daily.
Drug: Alendronate
Alendronate (Fosamax) 70mg every week.

Outcome Measures

Primary Outcome Measures :
  1. Spine Bone Mineral Density by DXA [ Time Frame: 12 months ]

Eligibility Criteria

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Ages Eligible for Study:   60 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01460654

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Endo Pharmaceuticals
Merck Sharp & Dohme Corp.
More Information

Responsible Party: Benjamin Leder, MD, Associate Professor of Medicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01460654     History of Changes
Other Study ID Numbers: MGH-988
First Posted: October 27, 2011    Key Record Dates
Last Update Posted: December 1, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Gonadal Disorders
Endocrine System Diseases
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents
Bone Density Conservation Agents