Testosterone and Alendronate in Hypogonadal Men

ID: NCT01460654
Status: Suspended
Phase: Phase 2
Start Date: October 01, 2011
First Submitted: October 20, 2011
Last Updated: February 22, 2018
Results: N/A
Sponsors & Collaborators: Massachusetts General Hospital, Endo Pharmaceuticals, Merck Sharp & Dohme Corp.
Location: United States
Conditions: Hypogonadism, Osteopenia, Osteoporosis
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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.

Detailed Description

Condition or disease Intervention/treatment Phase

Hypogonadism

Osteopenia

Osteoporosis

Drug: Testosterone
Other Names
Drug: Alendronate
Other Names
Drug: Placebo Alendronate
Other Names
Drug: Placebo Testosterone
Other Names
Phase 2

Tracking Information

First Submitted DateOctober 20, 2011
Last Update Posted DateFebruary 22, 2018
Start DateOctober 01, 2011
Anticipated Completion DateJune 01, 2019
Primary Completion DateJune 01, 2019
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • Spine Bone Mineral Density by DXA [Time Frame: 12 months]

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

Not Available

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleTestosterone and Alendronate in Hypogonadal Men
Official TitleTestosterone and Alendronate in Hypogonadal Men
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

Study TypeInterventional
Study PhasePhase 2
Estimated Enrollment
100
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
Single
Primary Purpose
Treatment
Conditions
Hypogonadism
Osteopenia
Osteoporosis
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Drug: Testosterone

Testosterone Gel (Fortesta) 40mg daily.

Other Names
Drug: Alendronate

Alendronate (Fosamax) 70mg every week.

Other Names
Drug: Placebo Alendronate

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

Other Names
Drug: Placebo Testosterone

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

Other Names
Study Groups/Cohorts
Testosterone and Placebo Alendronate

Alendronate and Placebo Testosterone

Testosterone and Alendronate

Study Arms
Placebo Comparator Alendronate and Placebo Testosterone
Drug : Alendronate
Alendronate (Fosamax) 70mg every week.

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

Experimental Testosterone and Alendronate
Drug : Alendronate
Alendronate (Fosamax) 70mg every week.

Experimental Testosterone and Alendronate
Drug : Testosterone
Testosterone Gel (Fortesta) 40mg daily.

Placebo Comparator Testosterone and Placebo Alendronate
Drug : Testosterone
Testosterone Gel (Fortesta) 40mg daily.

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

Arm Intervention/Treatment
Placebo Comparator Alendronate and Placebo Testosterone
Drug : Alendronate
Placebo Comparator Alendronate and Placebo Testosterone
Drug : Placebo Testosterone
Experimental Testosterone and Alendronate
Drug : Alendronate
Experimental Testosterone and Alendronate
Drug : Testosterone
Placebo Comparator Testosterone and Placebo Alendronate
Drug : Testosterone
Placebo Comparator Testosterone and Placebo Alendronate
Drug : Placebo Alendronate

Recruitment Information

Recruitment Status:Suspended
Enrollment100
Completion DateJune 01, 2019
Eligibility 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
GenderMale
Age60 Years to 85 Years
Accepts Healthy VolunteersAccepts Healthy Volunteers
Contacts
Not Available
Listed Location Countries
United States

Administrative Information

NCT Number:NCT01460654
Other Study ID Numbers
MGH-988
Has Data Monitoring CommitteeYes
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible PartyBenjamin Leder, MD, Massachusetts General Hospital
Study Sponsor
Massachusetts General Hospital
Collaborators
Endo Pharmaceuticals
Merck Sharp & Dohme Corp.
Investigators
Not Available