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Testosterone and Alendronate in Hypogonadal Men

This study is currently recruiting participants.
Verified December 2012 by Massachusetts General Hospital
Sponsor:
Collaborators:
Endo Pharmaceuticals
Merck
Information provided by (Responsible Party):
Benjamin Leder, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01460654
First received: October 20, 2011
Last updated: December 13, 2012
Last verified: December 2012
History of Changes
  Purpose

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 Intervention Phase
Hypogonadism
Osteopenia
Osteoporosis
 Drug: Testosterone
Drug: Alendronate
Drug: Placebo Alendronate
Drug: Placebo Testosterone
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Testosterone and Alendronate in Hypogonadal Men

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Spine Bone Mineral Density by DXA [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: October 2011
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: Tesosterone and Alendronate Drug: Testosterone
Testosterone Gel (Fortesta) 40mg daily.
Drug: Alendronate
Alendronate (Fosamax) 70mg every week.

  Eligibility

Ages Eligible for Study:   60 Years to 85 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01460654

Contacts
Contact: Alexander V Uihlein, MD 617-643-9720 auihlein@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Alexander V Uihlein, MD     617-643-9720     auihlein@partners.org    
Principal Investigator: Benjamin Z Leder, MD            
Sponsors and Collaborators
Massachusetts General Hospital
Endo Pharmaceuticals
Merck
  More Information

No publications provided

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
Study First Received: October 20, 2011
Last Updated: December 13, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 22, 2013