To evaluate the noninferiority of a 6-month treatment with 210 mg romosozumab at 90 mg/mL administered subcutaneously (SC) once a month (QM) in postmenopausal women with osteoporosis either by healthcare provider (HCP) administration with prefilled syringe (PFS) or by subject self-administration with autoinjector/pen (AI/Pen)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
283
210 mg romosozumab SC QM by HCP administration with 2 PFS
210 mg romosozumab SC QM by self-administration with 2 AI/Pens
Percent Change From Baseline in Lumbar Spine BMD at Month 6
Percent change from baseline in BMD at the lumbar spine as measured by dual-energy x-ray absorptiometry (DXA).
Time frame: Baseline, Month 6
Percent Change From Baseline in Total Hip BMD at Month 6
Percent change from baseline in BMD for total hip as measured by DXA.
Time frame: Baseline, Month 6
Percent Change From Baseline in Femoral Neck BMD at Month 6
Percent change from baseline in BMD at femoral neck as measured by DXA.
Time frame: Baseline, Month 6
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Device-Related AEs, Discontinuations Due to AEs, and Deaths
AE: any untoward medical occurrence irrespective of a causal relationship with the study treatment. SAE: any untoward medical occurrence that meets at least 1 of the following criteria: results in death; is immediately life-threatening; requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a medically important serious event. Adverse device effect: any AE related to the use of a combination product or medical device. TEAEs are those AEs occurring after first dose of study drug.
Time frame: up to Month 9 (-7/+3 days)
Number of Participants Developing Anti-Romosozumab Antibodies
Participants with a negative or no result at baseline (BL) developing anti-romosozumab antibodies postbaseline, including those who were binding antibody-positive or neutralizing antibody-positive postbaseline. 'Transient' positive results are those with a negative result at the participant's last time point tested within the study period.
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Research Site
Birmingham, Alabama, United States
Research Site
Birmingham, Alabama, United States
Research Site
Huntsville, Alabama, United States
Research Site
Tuscaloosa, Alabama, United States
Research Site
Chandler, Arizona, United States
Research Site
Mesa, Arizona, United States
Research Site
Cypress, California, United States
Research Site
Fullerton, California, United States
Research Site
Glendale, California, United States
Research Site
Laguna Hills, California, United States
...and 36 more locations
Time frame: up to Month 9 (-7/+3 days)