A Study on Biosimilar Denosumab for Postmenopausal Osteoporosis
Objective
This study aimed to compare the safety and effectiveness of a biosimilar version of denosumab with the original product, Prolia, in Indian women with postmenopausal osteoporosis. Denosumab helps regulate bone turnover by decreasing bone loss.
Methods
This was a phase III, double-blind study involving postmenopausal women with osteoporosis. Participants were randomly divided into two groups: one received the biosimilar denosumab (Treatment A) and the other received Prolia (Treatment B). All participants also took daily vitamin D3 and calcium supplements. The main outcomes measured were changes in bone mineral density (BMD) at the lumbar spine and femoral neck over 12 months.
Results
After 6 months, the change in lumbar spine BMD was:
- Group A (Biosimilar): 5.69 ± 0.88
- Group B (Prolia): 5.08 ± 1.19
After 12 months:
- Group A: 7.26 ± 1.05
- Group B: 7.31 ± 1.40
Both groups showed significant improvements in femoral neck BMD at 12 months. No significant differences were found in key pharmacokinetic parameters.
Conclusion
The biosimilar denosumab was found to be as effective and safe as the reference denosumab. This means that it can potentially improve the quality of life for patients with osteoporosis at more affordable prices.
Value of Clinical Trials
Clinical trials are essential for developing safe treatments. Our AI-driven platform, DocSym, combines clinical guidelines and research into a single resource for healthcare providers.
Practical Solutions
To enhance patient care, our mobile apps assist with:
- Scheduling appointments
- Monitoring treatments
- Providing telemedicine services
By leveraging AI, clinics can improve workflows and patient outcomes while reducing paperwork. Discover more at aidevmd.com.
