drugset / Trial / NCT02602704
Effectiveness of Bazedoxifene for Prevention of Glucocorticoid-induced Bone Loss in RA Patients
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
Publications
- Cho SK, Song YJ, Kim HW, Nam E, Jeon JY, Yoo HJ, Sung YK. Comparative effectiveness of tofacitinib and tumour necrosis factor inhibitors in patients with rheumatoid arthritis in real-world practice: a prospective observational study. Rheumatology (Oxford). 2025 Feb 1;64(2):541-547. doi: 10.1093/rheumatology/keae109.
- Cho SK, Kim H, Lee J, Nam E, Lee S, Choi YY, Sung YK. Effectiveness of bazedoxifene in preventing glucocorticoid-induced bone loss in rheumatoid arthritis patients. Arthritis Res Ther. 2021 Jul 2;23(1):176. doi: 10.1186/s13075-021-02564-1.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Bazedoxifene | Other / unclassified | 20 mg | — |
| Comparator | Calcium carbonate | Other / unclassified | 1200 mg | — |
| Comparator | Calcium/Vit D | Unknown | 800 iu | — |