Study Complete
Sponsor ID
20150120

A Comparison of Subject-administered Romosozumab with Healthcare Provider-administered Romosozumab for Osteoporosis

Sponsor ID
20150120
Clinicaltrials.gov ID
NCT03432533
EUCTIS ID
N/A
EudraCT ID
2017-003512-40

Study Details

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)

Additional Study Details

Phase
Phase 3
Product
romosozumab
Type
Interventional
Masking
None (Open Label)
Enrollment
283
Additional Study Details

Protocol Summary

Primary Outcome Measures

Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Month 6

Timeframe: Baseline, Month 6

Secondary Outcome Measures

Percent Change From Baseline in Total Hip BMD at Month 6

Timeframe: Baseline, Month 6

Percent Change From Baseline in Femoral Neck BMD at Month 6

Timeframe: Baseline, Month 6

Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Device-Related AEs, Discontinuations Due to AEs, and Deaths

Timeframe: up to Month 9 (-7/+3 days)

Number of Participants Developing Anti-Romosozumab Antibodies

Timeframe: up to Month 9 (-7/+3 days)

Locations

Location
Status
Contact Us
Location
Research Site
Duncansville, PA, United States, 16635
Status
Recruiting
Location
Research Site
Summerville, SC, United States, 29486
Status
Recruiting
Location
Research Site
Danville, VA, United States, 24541
Status
Recruiting
Location
Research Site
Golden, CO, United States, 80401
Status
Recruiting
Location
Research Site
Wyomissing, PA, United States, 19610
Status
Recruiting
Location
Research Site
Laguna Hills, CA, United States, 92653
Status
Recruiting
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