Testosterone and Alendronate in Hypogonadal Men
1 other identifier
interventional
44
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Oct 2011
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 20, 2011
CompletedFirst Posted
Study publicly available on registry
October 27, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedResults Posted
Study results publicly available
October 12, 2023
CompletedOctober 12, 2023
October 1, 2023
2.6 years
October 20, 2011
September 6, 2023
October 10, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Percent Change in Spine Bone Density From Baseline to 12 Months
Percent Change in Spine Bone Density from Baseline (month 0) to Month 12
Baseline and 12 months
Study Arms (3)
Testosterone and Placebo Alendronate
PLACEBO COMPARATORAlendronate and Placebo Testosterone
PLACEBO COMPARATORTestosterone and Alendronate
EXPERIMENTALInterventions
Testosterone Gel (Fortesta) 40mg daily.
Alendronate (Fosamax) 70mg every week.
A placebo alendronate tablet will be taken every week by subjects in the Testosterone and Placebo Alendronate Group.
Placebo testosterone gel will be applied daily by subjects in the Alendronate and Placebo Testosterone group.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Massachusetts General Hospitallead
- Endo Pharmaceuticalscollaborator
- Merck Sharp & Dohme LLCcollaborator
Study Sites (1)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Benjamin Leder
- Organization
- Massachusetts General Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Medicine
Study Record Dates
First Submitted
October 20, 2011
First Posted
October 27, 2011
Study Start
October 1, 2011
Primary Completion
May 1, 2014
Study Completion
December 1, 2014
Last Updated
October 12, 2023
Results First Posted
October 12, 2023
Record last verified: 2023-10