Effectiveness of bazedoxifene in preventing glucocorticoid-induced bone loss in rheumatoid arthritis patients

Arthritis Research & Therapy

Jiyoung Lee¹  Yun Young Choi²  Seunghun Lee³  Hyoungyoung Kim⁴  Eunwoo Nam⁴  Soo-Kyung Cho⁴  Yoon-Kyoung Sung⁴ 

[1] Clinical Research Center for Rheumatoid Arthritis (CRCRA), 222 wangsimni-ro, Seongdong-gu, 04763, Seoul, South Korea;Department of Nuclear Medicine, Hanyang University College of Medicine, 222 wangsimni-ro, Seongdong-gu, 04763, Seoul, South Korea;Department of Radiology, Hanyang University College of Medicine, 222 wangsimni-ro, Seongdong-gu, 04763, Seoul, South Korea;Hanyang University Hospital for Rheumatic Diseases, 222-1 wangsimni-ro, Seongdong-gu, 04763, Seoul, South Korea;

关键词: Bazedoxifene;    Rheumatoid arthritis;    Glucocorticoids;    Osteopenia;    Bone loss;   

DOI  :  10.1186/s13075-021-02564-1

来源: Springer

【 摘 要 】

ObjectiveTo evaluate the effectiveness of bazedoxifene in preventing bone loss in patients with rheumatoid arthritis (RA) receiving low-dose glucocorticoids (GCs).MethodsIn this randomized, controlled, open-label study, we assigned postmenopausal women with osteopenia who had been receiving low-dose GCs for RA to two groups: a group receiving bazedoxifene (20 mg/day) with elemental calcium 1200 mg and vitamin D 800 IU daily (bazedoxifene group) and a group receiving the same doses of calcium and vitamin D only (control group). As primary outcome, bone mineral density (BMD) change in the lumbar spine (L-spine) from baseline to 48 weeks was assessed. Changes in BMD in the femur, trabecular bone score, bone turnover markers, and development of fracture were assessed as secondary outcomes. For intention-to-treat analysis, 20 completed data sets were created by applying multiple imputations by chained equations.ResultsA total of 114 patients (57 patients in each group) were recruited. A significant increase in L-spine BMD (0.015 g/cm2, P = 0.007) was observed in the bazedoxifene group, and the increase was significantly higher than in the control group (0.013, 95% CI 0.0003–0.026, P = 0.047). Reductions in bone turnover markers in the bazedoxifene group were significantly greater than in the control group. Only one fracture was observed in the bazedoxifene group, while four fractures developed in the control group.ConclusionIn postmenopausal patients with RA receiving low-dose GCs, bazedoxifene improved BMD and reduced bone turnover markers. However, the change in BMD did not exceed the least significant change.Trial registrationClinicalTrials.gov, NCT02602704.

【 授权许可】

CC BY