How effective is bazedoxifene in preventing bone loss due to glucocorticoids in patients with rheumatoid arthritis?

This study assessed the effectiveness of bazedoxifene (Duavee) in the prevention of bone loss in patients with rheumatoid arthritis (RA) while receiving low-dose glucocorticoid (GC) treatments. The data showed improved bone mineral density (BMD) and reduced bone turnover markers (BTMs) in these patients.

RA is a chronic, inflammatory disease that increases the risk of patients developing weakened, brittle bones (osteoporosis) and broken bones (fractures). Osteoporosis is defined as reduced bone mineral density (BMD). Also, in patients with osteoporosis, there is an increase in bone turnover markers (BTM) in the blood. BTMs are proteins released in the blood when bone is destroyed in osteoporosis. 

GCs are given to patients during the early stages of RA to manage inflammation. However, prolonged GC treatment contributes to osteoporosis. Although oral bisphosphonates are an effective first-line therapy for preventing fractures when given with calcium and vitamin D supplements, long-term use is associated with side effects.

Selective estrogen receptor modulators (SERMs) such as raloxifene (Evista) and bazedoxifene have been shown to prevent bone loss and reduce the risk of fractures in postmenopausal women with osteoporosis. However, the effectiveness of SERMs in the prevention of osteoporosis resulting from GCs is currently unknown. 

This study included 114 postmenopausal women with RA. All patients were receiving low-dose GCs for RA. Patients were divided in 2 groups. One group received bazedoxifene 20 mg daily with 1200 mg calcium and 800 IU of vitamin D. Group 2 received calcium and vitamin D only (control group). The study lasted for 56 weeks.

A significant BMD improvement in the lumbar spine was seen in the bazedoxifene group compared to the control group after 48 weeks. Also, BTMs were significantly reduced after 24 weeks in the patients that received bazedoxifene compared to those in the control group. These changes in BTMs were maintained after 48 weeks. 

One patient in the bazedoxifene group had a fracture during the study compared to 4 patients in the control group. Serious side effects were more common in the control group (17.5%) compared to the bazedoxifene group (12.3%).

The study showed that bazedoxifene improved BMD in postmenopausal women with RA that received low-dose GCs.

The study had a small number of participants. Funding support was provided through a grant from Pfizer, the developers of bazedoxifene.