A Study to Compare SB16 (Proposed Denosumab Biosimilar) to Prolia® in Postmenopausal Women With Osteoporosis
Phase 3
Completed
NCT04664959
| Condition | Postmenopausal Osteoporosis |
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| Phase | Phase 3 |
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| Sponsor | Samsung Bioepis Co., Ltd. |
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| Status | Completed |
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| Enrollment | 457 participants |
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| Interventions | SB16 (Proposed Denosumab Biosimilar), Prolia® (Denosumab) |
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| Start date | Nov 26, 2020 |
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| Completion date | Jun 20, 2022 |
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| Results posted | Jan 9, 2025 |
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Summary
This is a randomised, double-blind, multicentre study to evaluate the efficacy, safety, PK, PD, and immunogenicity of SB16 compared to Prolia® in postmenopausal women with osteoporosis.
Percent Change From Baseline in Lumbar Spine BMD at Month 12
Baseline and Month 12 · %Change of BMD
| SB16 | 5.63 ± 0.250 %Change of BMD |
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| Prolia | 5.30 ± 0.254 %Change of BMD |
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Open in BENITIONS
View on ClinicalTrials.gov
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