In patients with osteoporosis, biosimilar RGB-10 and reference teriparatide showed equivalent lumbar spine L2-L4 BMD efficacy.
In plain wordsIn patients with osteoporosis, biosimilar RGB-10 and reference teriparatide had equivalent effects on spine bone density.
- Peptide
- Teriparatide (PTH 1-34)
- Outcome
- No significant changeLumbar spine L2-L4 BMD
- Study
n = 250
- Comparator
- Reference teriparatide
- Analysis
- Primary
- Outcome group
- Bone and joint · Musculoskeletal
- Studied dose
- 20 μg once daily · subcutaneous · 52 weeksAs given in this study (human).
Measurements
- BMD change
- 8.94%
- RGB-10
- BMD change
- 9.65%
- reference teriparatide
- Between-group difference in BMD change
- −0.65%
- RGB-10 minus reference teriparatide
Source sentences
The estimated between-group difference (95% confidence interval) was - 0.65% (- 2.17% to - 0.87%) within the pre-specified equivalence margin (± 2.8%), which indicates equivalence in efficacy between the two groups.
3 context sentences(design, population, supporting numbers)
The percent change from baseline to 52 weeks in lumbar spine (L2-L4) BMD (mean ± standard deviation) was 8.94% ± 6.19% in the RGB-10 group and 9.65% ± 6.22% in the reference teriparatide group.
The primary efficacy endpoint was the percent change from baseline to 52 weeks in lumbar spine (L2-L4) bone mineral density (BMD).
Ambulatory postmenopausal women and men (≥ 55 years of age) with osteoporosis at high risk of fracture were randomized 1:1 to receive either RGB-10 or reference teriparatide 20 μg once daily via subcutaneous self-injection for 52 weeks.