drugset / Trial / NCT04177940
Denosumab (DMAB) Discontinuation And Switching In Glucocorticoid-Induced Osteoporosis (GIOP): A Pilot Study
Phase 4
Completed
45 enrolled
University of Alabama at Birmingham
Amgen · collabMaastricht University · collabVrije Universiteit Brussel · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
Investigators will test the hypothesis that an increase in bone turnover markers (e.g. carboxy-terminal collagen crosslinks (CTX) and P1NP) in patients currently taking chronic glucocorticoids will be attenuated more in those who switch from denosumab to "late" zoledronic acid (9 months after last denosumab dose) compared to participants randomized to "early" zoledronic acid (6 months after last denosumab dose) or weekly alendronate (6 months after last denosumab dose).
Timeline
- Start
- 2020-08-17
- Primary completion
- 2024-07-22
- Completion
- 2025-01-14
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Alendronic Acid | Small molecule | 70 mg | Oral |
| Comparator | Denosumab | Monoclonal antibody | 60 mg | Subcutaneous |
| Comparator | Zoledronic acid | Other / unclassified | 5 mg | — |