NCT05091086

The Optimal Long Term Treatment Strategy of Anti-resorptive Medications

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: National Taiwan University Hospital · Academic / Other
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study is to investigate whether the alternating use of Prolia (Denosumab) and Aclasta (Zoledronic acid) can continue to increase bone density.

Detailed description

This study intends to use a randomized trial to test whether the long-term treatment of Denosumab and Zoledronic acid can achieve sustained bone density progress and avoid the risk of rapid bone loss after the withdrawal of Denosumab.

Conditions

• Osteoporosis
• Bone Mineral Density

Interventions

Type	Name	Description
DRUG	Continuous Denosumab	Active comparator: persistent treatment of denosumab.
DRUG	Administer zoledronate and denosumab on an alternating schedule	In the experimental group, zoledronic acid was administered for one year, followed by two years of denosumab. This cycle was repeated, with the regimen concluding with one year of zoledronic acid.

Timeline

• Start date: 2021-11-20
• Primary completion: 2025-12-31
• Completion: 2030-12-31
• First posted: 2021-10-25
• Last updated: 2025-05-22

Locations

1 site across 1 country: Taiwan

Regulatory

• FDA-regulated drug study