Efficacy and safety of sodium RISedronate for glucocorticoid-induced OsTeoporosis with rheumaTOid arthritis (RISOTTO study): A multicentre, double-blind, randomized, placebo-controlled trial

Abstract

Objective

No evidence has shown the efficacy of Sodium Risedronate (Risedronate) for glucocorticoid-induced osteoporosis (GIO) in patients with Rheumatoid arthritis (RA). The aim of this study was to explore the effectiveness and safety of Risedronate for GIO complicated with RA.

Methods

This was a six-month randomized, double-blind, placebo-controlled trial of 95 patients with GIO complicated with RA from 19 centers. The primary endpoint was the change from baseline in lumbar spine bone mineral density (L-BMD). Secondary endpoints included changes in femoral neck and total hip BMD and bone turnover markers, as well as rheumatoid arthritis Disease Activity Score with 28-joint counts. Incident of non-traumatic spine fractures and adverse events were tracked as safety endpoints.

Results

Increase in L-BMD was significantly greater in the Risedronate group compared to the Placebo group (Risedronate: 3.49% [95% CI: 1.92–5.05] vs Placebo: 0.12% [95% CI: −2.07 to 2.30], p < .0001). No significant difference was found in the femoral neck and total hip BMD. Although adverse events were observed in 28 patients, none were considered serious. Non-traumatic vertebral fractures were identified in 10 patients.

Conclusion

Risedronate was effective in increasing L-BMD and was well tolerated in patients with GIO complicated with RA.

Keywords:

• Glucocorticoid-induced osteoporosis
• rheumatoid arthritis
• randomized control study
• sodium risedronate

Acknowledgments

We would like to thank the patients for participating and Nao Horie for supporting this study as a clinical research coordinator.

Conflict of interests

Dr. Atsumi reports personal fees from Eisai, during the conduct of the study; grants and personal fees from Astellas, grants and personal fees from Takeda, grants and personal fees from Mitsubishi Tanabe, grants and personal fees from Chugai, grants and personal fees from Pfizer, grants from Daiichi Sankyo, grants from Otsuka, personal fees from AbbVie, outside the submitted work. Dr. Yasuda reports grants from Bristol-Myers Squibb Co., personal fees from Chugai Pharmaceutical Co., Ltd., Mitsubishi Tanabe Pharma Co., Pfizer Inc., and GlaxoSmithKline, outside the submitted work. Dr. Kato has received research grants from AbbVie, Actelion, and GlaxoSmithKline and speaking fees from Eli Lilly. The other authors declare no conflict of interest associated with this manuscript.