Real-world efficacy of a teriparatide biosimilar (RGB-10) compared with reference teriparatide on bone mineral density, trabecular bone score, and bone parameters assessed using quantitative ultrasound, 3D-SHAPER® and high-resolution peripheral computer tomography in postmenopausal women with osteoporosis and very high fracture risk
Authors' conclusion
The results of the analysis demonstrate the therapeutic equivalence of the teriparatide biosimilar (RGB-10) to reference teriparatide for the treatment of osteoporosis in postmenopausal women at very high risk of fracture.
Study context
- Population
- Postmenopausal women with osteoporosis at very high fracture riskmatched cohort
- Participants
- 25 vs 25
- Exposure
- Teriparatide biosimilar vs reference teriparatide
- RGB-10n = 25
- Reference teriparatiden = 25reference
- Outcome
- BMD (lumbar spine, femoral neck, total hip by DXA; 3D-SHAPER), trabecular bone score (TBS), quantitative ultrasound (QUS) and high-resolution peripheral quantitative computed tomography (HRpQCT) of radius and tibia
- Follow-up
- Baseline, 12 and 24 months
Methodological detailsmatched cohort
- Matched cohort
Main finding
As reported in the abstract
BMD and bone health parameters · 12 and 24 months
- No significant differences between treatment groups in any measured bone mineral density (BMD) or bone health parameter at baseline or any timepoint
- Both compounds provided equivalent significant improvements from baseline in measures of osteoporosis and fracture risk
- Matched cohort
Observational data: associations, not effects.
Original publication
Real-world efficacy of a teriparatide biosimilar (RGB-10) compared with reference teriparatide on bone mineral density, trabecular bone score, and bone parameters assessed using quantitative ultrasound, 3D-SHAPER® and high-resolution peripheral computer tomography in postmenopausal women with osteoporosis and very high fracture risk. Osteoporos Int. Published 2 August 2024. doi:10. 1007/ s00198-024-07208-z
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