Teriparatide non-inferior to Alendronate for BMD in Osteoporosis
New research revealed that Teriparatide was non-inferior to Alendronate in increasing Bone Mineral Density (BMD) in the lumbar spine in Chinese Post-menopausal women. The study was published in the journal "Archives of Osteoporosis, 2022."
Osteoporosis is a progressive skeletal disease affecting the old age population, especially post-menopausal women, and causing low bone mineral density. Researchers from China conducted a study to determine if the efficacy of generic teriparatide is non-inferior to alendronate among Chinese postmenopausal women with osteoporosis.
A randomized open-label study was conducted by assigning eligible patients in the ratio of 2:1 to receive 20 µg sc daily teriparatide or 70 mg oral weekly alendronate. Patients were observed for 48 weeks. Percentage change in BMD at the lumbar spine from baseline to 48 weeks and assessment for non-inferiority was the primary outcome of the measurement. The same outcome was further assessed for superiority as a secondary endpoint.
Results:
- 391 and 196 participants were randomly assigned to the teriparatide or alendronate group, of whom 379 and 194 receiving at least one dose of teriparatide and alendronate treatment were eligible for the efficacy analysis.
- Teriparatide was non-inferior to alendronate for BMD change at the lumbar spine, which excluded the predefined non-inferiority margin of − 1.5%.
- However, teriparatide was not statistically superior to alendronate in improving BMD in the lumbar spine.
- At 48 weeks, changes in the BMD at the total hip were − 1.0% and 2.2% in the teriparatide and alendronate group, respectively (P < 0.001).
- There was no statistical difference between groups in the incidence of new fracture.
- Serum P1NP and β-CTX levels significantly increased in the teriparatide group and markedly decreased in the alendronate group.
- The adverse events (AEs) and serious AEs were more common in the teriparatide group than in the alendronate group, which were mainly teriparatide-related hypercalcemia, elevated alkaline phosphatase or parathyroid hormone, dizziness, and arthralgia.
Thus, the researchers concluded that Teriparatide increased BMD through a different mechanism from Alendronate and was not inferior to alendronate in increasing BMD in the lumbar spine in Chinese postmenopausal women.
For the full article, click here: https://doi.org/10.1007/s11657-022-01131-8
Li, M., Zhang, Z., Xue, Q. et al. Efficacy of generic teriparatide and alendronate in Chinese postmenopausal women with osteoporosis: a prospective study. Arch Osteoporos 17, 103 (2022).
