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Testosterone and Alendronate in Hypogonadal Men

Primary Purpose

Hypogonadism, Osteopenia, Osteoporosis

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Testosterone

Alendronate

Placebo Alendronate

Placebo Testosterone

About this trial

This is an interventional treatment trial for Hypogonadism

Eligibility Criteria

60 Years - 85 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Arm Label

Testosterone and Placebo Alendronate

Alendronate and Placebo Testosterone

Testosterone and Alendronate

Arm Description

Outcomes

Primary Outcome Measures

Percent Change in Spine Bone Density From Baseline to 12 Months

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

Secondary Outcome Measures

Full Information

NCT ID

NCT01460654

First Posted

October 20, 2011

Last Updated

October 10, 2023

Sponsor

Massachusetts General Hospital

Collaborators

Endo Pharmaceuticals, Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT01460654

Brief Title

Testosterone and Alendronate in Hypogonadal Men

Official Title

Testosterone and Alendronate in Hypogonadal Men

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Terminated

Study Start Date

October 2011 (undefined)

Primary Completion Date

May 2014 (Actual)

Study Completion Date

December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Massachusetts General Hospital

Collaborators

Endo Pharmaceuticals, Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypogonadism, Osteopenia, Osteoporosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

44 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Testosterone and Placebo Alendronate

Arm Type

Placebo Comparator

Arm Title

Alendronate and Placebo Testosterone

Arm Type

Placebo Comparator

Arm Title

Testosterone and Alendronate

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Testosterone

Intervention Description

Testosterone Gel (Fortesta) 40mg daily.

Intervention Type

Drug

Intervention Name(s)

Alendronate

Intervention Description

Alendronate (Fosamax) 70mg every week.

Intervention Type

Drug

Intervention Name(s)

Placebo Alendronate

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo Testosterone

Intervention Description

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

Primary Outcome Measure Information:

Title

Percent Change in Spine Bone Density From Baseline to 12 Months

Description

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

Time Frame

Baseline and 12 months

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

60 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

Massachusetts General Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

12. IPD Sharing Statement

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Testosterone and Alendronate in Hypogonadal Men

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