- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01460654
Testosterone and Alendronate in Hypogonadal Men
October 10, 2023 updated by: Benjamin Leder, MD, Massachusetts General Hospital
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
44
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Testosterone and Placebo Alendronate
|
Testosterone Gel (Fortesta) 40mg daily.
A placebo alendronate tablet will be taken every week by subjects in the Testosterone and Placebo Alendronate Group.
|
Placebo Comparator: Alendronate and Placebo Testosterone
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Alendronate (Fosamax) 70mg every week.
Placebo testosterone gel will be applied daily by subjects in the Alendronate and Placebo Testosterone group.
|
Experimental: Testosterone and Alendronate
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Testosterone Gel (Fortesta) 40mg daily.
Alendronate (Fosamax) 70mg every week.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent Change in Spine Bone Density From Baseline to 12 Months
Time Frame: Baseline and 12 months
|
Percent Change in Spine Bone Density from Baseline (month 0) to Month 12
|
Baseline and 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2011
Primary Completion (Actual)
May 1, 2014
Study Completion (Actual)
December 1, 2014
Study Registration Dates
First Submitted
October 20, 2011
First Submitted That Met QC Criteria
October 25, 2011
First Posted (Estimated)
October 27, 2011
Study Record Updates
Last Update Posted (Actual)
October 12, 2023
Last Update Submitted That Met QC Criteria
October 10, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Metabolic Diseases
- Endocrine System Diseases
- Gonadal Disorders
- Musculoskeletal Diseases
- Bone Diseases
- Osteoporosis
- Hypogonadism
- Bone Diseases, Metabolic
- Physiological Effects of Drugs
- Antineoplastic Agents
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Bone Density Conservation Agents
- Androgens
- Anabolic Agents
- Alendronate
- Testosterone
- Methyltestosterone
- Testosterone undecanoate
- Testosterone enanthate
- Testosterone 17 beta-cypionate
Other Study ID Numbers
- MGH-988
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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