DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Testosterone and Alendronate in Hypogonadal Men

Information source: Massachusetts General Hospital
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypogonadism; Osteopenia; Osteoporosis

Intervention: Testosterone (Drug); Alendronate (Drug); Placebo Alendronate (Drug); Placebo Testosterone (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Massachusetts General Hospital

Overall contact:
Alexander V Uihlein, MD, Phone: 617-643-9720, Email: auihlein@partners.org


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.

Clinical Details

Official title: Testosterone and Alendronate in Hypogonadal Men

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Primary outcome: Spine Bone Mineral Density by DXA


Minimum age: 60 Years. Maximum age: 85 Years. Gender(s): Male.


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

Locations and Contacts

Alexander V Uihlein, MD, Phone: 617-643-9720, Email: auihlein@partners.org

Massachusetts General Hospital, Boston, Massachusetts 02114, United States; Recruiting
Katelyn Foley, BA, Phone: 617-726-2860, Email: kfoley11@partners.org
Benjamin Z Leder, MD, Principal Investigator
Additional Information

Starting date: October 2011
Last updated: June 25, 2014

Page last updated: August 20, 2015

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017