This study will compare the effect of denosumab produced by two different manufacturing processes on bone mineral density at the lumbar spine in postmenopausal women with osteoporosis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
394
Denosumab produced by a process referred to as CP2, administered subcutaneously from a prefilled syringe.
Denosumab produced by a process referred to as CP4, administered subcutaneously from a prefilled syringe.
Research Site
Santa Maria, California, United States
Research Site
South Lake Tahoe, California, United States
Percent Change From Baseline in Lumbar Spine BMD
Lumbar spine bone mineral density (BMD) was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.
Time frame: Baseline and Month 12
Percent Change From Baseline in Serum Type I Collagen C-telopeptide (sCTX)
Time frame: Baseline, month 1, month 6 and month 12
Percent Change From Baseline in Serum Procollagen Type 1 N-terminal Propeptide (P1NP)
Time frame: Baseline, month 1, month 6 and month 12
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Research Site
Lakewood, Colorado, United States
Research Site
Gainesville, Georgia, United States
Research Site
Bethesda, Maryland, United States
Research Site
Detroit, Michigan, United States
Research Site
Albuquerque, New Mexico, United States
Research Site
Akron, Ohio, United States
Research Site
Bend, Oregon, United States
Research Site
Duncansville, Pennsylvania, United States
...and 13 more locations