drugset / Trial / NCT02602704

Effectiveness of Bazedoxifene for Prevention of Glucocorticoid-induced Bone Loss in RA Patients

NCT02602704 ↗

Phase 4 Completed 114 enrolled Hanyang University Pfizer · collab
RandomizedParallel-groupOpen-labelPrevention

Summary

* The purpose of this study is to study the effectiveness of bazedoxifene in preventing loss of bone mineral density (BMD) and trabecular bone score (TBS), and any fractures in postmenopausal rheumatoid arthritis (RA) patients receiving long-term GCs. * This is a randomized, controlled, open-label extension study for 48 or 56 weeks. At study entry, all patients will receive elemental calcium (1200 mg daily) and vitamin D (800 IU daily) and will be randomized by blocks of two to receive either bazedoxifene (20 mg/day) or none.

Timeline

Start
2015-12-29
Primary completion
2017-10-11
Completion
2018-12-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Bazedoxifene Other / unclassified 20 mg —
Comparator Calcium Small molecule 1200 mg —
Comparator Calcium/Vit D Unknown 800 iu —

Indications