Hanyang University Hospital for Rheumatic Diseases, 222-1 wangsimni-ro, Seongdong-gu, Seoul, 04763, South Korea.
Clinical Research Center for Rheumatoid Arthritis (CRCRA), 222 wangsimni-ro, Seongdong-gu, Seoul, 04763, South Korea.
Arthritis Res Ther. 2021 Jul 2;23(1):176. doi: 10.1186/s13075-021-02564-1.
To evaluate the effectiveness of bazedoxifene in preventing bone loss in patients with rheumatoid arthritis (RA) receiving low-dose glucocorticoids (GCs).
In 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.
A total of 114 patients (57 patients in each group) were recruited. A significant increase in L-spine BMD (0.015 g/cm, 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.
In 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.
ClinicalTrials.gov, NCT02602704 .
评估巴多昔芬预防接受低剂量糖皮质激素（GCs）治疗的类风湿关节炎（RA）患者骨丢失的疗效。
在这项随机、对照、开放标签研究中，我们将接受低剂量 GCs 治疗的绝经后骨质疏松症 RA 患者分为两组：一组接受巴多昔芬（20mg/天）联合元素钙 1200mg 和维生素 D 800IU （巴多昔芬组），另一组仅接受相同剂量的钙和维生素 D（对照组）。主要结局是从基线到 48 周时腰椎（L 脊柱）的骨矿物质密度（BMD）变化。次要结局包括股骨、小梁骨评分、骨转换标志物的变化以及骨折的发生。对于意向治疗分析，通过链方程多重插补创建了 20 个完整数据集。
共纳入 114 例患者（每组 57 例）。巴多昔芬组 L 脊柱 BMD 显著增加（0.015g/cm，P=0.007），且高于对照组（0.013，95%CI 0.0003-0.026，P=0.047）。巴多昔芬组骨转换标志物的降低明显大于对照组。巴多昔芬组仅发生 1 例骨折，对照组发生 4 例骨折。
在接受低剂量 GCs 治疗的绝经后 RA 患者中，巴多昔芬可提高 BMD 并降低骨转换标志物。然而，BMD 的变化未超过最小有意义的变化。
ClinicalTrials.gov，NCT02602704。
