8
Participants
Start Date
January 31, 2012
Primary Completion Date
October 31, 2014
Study Completion Date
October 31, 2014
Denosumab
"The dose of denosumab is 60 mg every 6 months by subcutaneous injection.~The 52 subjects will be randomly allocated (2:1) into treatment and placebo arms with the placebo group receiving a subcutaneous injection of vehicle in year 1. In year 2, those who were allocated to the study drug in year 1 will continue in year 2. Those who were allocated to placebo in year 1 will be crossed over to study drug in year 2.~Group # 1: Receive active drug for year 1 and year 2 of the study~Group #2: Receive placebo for year 1 and active drug for year 2 of the study"
Placebo
"The dose of denosumab is 60 mg every 6 months by subcutaneous injection. The placebo group will receive vehicle injections at the same time interval.~The 52 subjects will be randomly allocated (2:1) into treatment and placebo arms with the placebo group receiving a subcutaneous injection of vehicle in year 1. In year 2, those who were allocated to the study drug in year 1 will continue in year 2. Those who were allocated to placebo in year 1 will be crossed over to study drug in year 2.~Group # 1: Receive active drug for year 1 and year 2 of the study~Group #2: Receive placebo for year 1 and active drug for year 2 of the study"
Columbia University Medical Center, New York
Collaborators (1)
National Institutes of Health (NIH)
NIH
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Amgen
INDUSTRY
Columbia University
OTHER