Testosterone and Alendronate in Hypogonadal Men

Osteoporosis Clinical Trial

Official title:

Testosterone and Alendronate in Hypogonadal Men

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01460654
• Other study ID #: MGH-988
• Status: Terminated
• Phase: Phase 2
• Start date: October 2011
• Est. completion date: December 2014

Study information

• Verified date: October 2023
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 44
• Est. completion date: December 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 60 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Bone Diseases, Metabolic
• Hypogonadism
• Osteopenia
• Osteoporosis

Intervention

Drug:
• Testosterone
Testosterone Gel (Fortesta) 40mg daily.
• Alendronate
Alendronate (Fosamax) 70mg every week.
• Placebo Alendronate
A placebo alendronate tablet will be taken every week by subjects in the Testosterone and Placebo Alendronate Group.
• Placebo Testosterone
Placebo testosterone gel will be applied daily by subjects in the Alendronate and Placebo Testosterone group.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Endo Pharmaceuticals, Merck Sharp & Dohme LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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