This study will compare the effectiveness of denosumab treatment every 6 months with once yearly zoledronic acid treatment on bone mineral density (BMD) at various skeletal sites.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
643
Denosumab 60 mg administered by subcutaneous injection once every 6 months.
Zoledronic acid 5 mg administered by intravenous infusion once a year
Administered by subcutaneous injection once every 6 months
Percent Change From Baseline in Lumbar Spine Bone Mineral Density at Month 12 - Non-inferiority Analysis
Bone mineral density (BMD) of the lumbar spine was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging facility.
Time frame: Baseline and Month 12
Percent Change From Baseline in Total Hip BMD at Month 12 - Non-inferiority Analysis
BMD of the hip was measured by DXA. DXA scans were analyzed by a central imaging facility.
Time frame: Baseline and Month 12
Percent Change From Baseline in Lumbar Spine BMD at Month 12 - Superiority Analysis
Time frame: Baseline and Month 12
Percent Change From Baseline in Total Hip BMD at Month 12 - Superiority Analysis
Time frame: Baseline and Month 12
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Administered by intravenous infusion once a year
Research Site
Santa Monica, California, United States
Research Site
Lakewood, Colorado, United States
Research Site
Longmont, Colorado, United States
Research Site
Washington D.C., District of Columbia, United States
Research Site
Bethesda, Maryland, United States
Research Site
Hagerstown, Maryland, United States
Research Site
Detroit, Michigan, United States
Research Site
West Haverstraw, New York, United States
Research Site
Houston, Texas, United States
Research Site
Maroubra, New South Wales, Australia
...and 35 more locations