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

Autor: Yuichiro Fujieda, Tetsuya Horita, Naoki Nishimoto, Kazuhide Tanimura, Yoshiharu Amasaki, Hideki Kasahara, Shin Furukawa, Tsuyoshi Takeda, Shinji Fukaya, Kazuo Matsui, Akito Tsutsumi, Akira Furusaki, Akira Sagawa, Kou Katayama, Kaoru Takeuchi, Kazuaki Katsumata, Takashi Kurita, Shane, Peter, Masaru Kato, Kenji Oku
Předmět:
Zdroj: Modern Rheumatology; May 2021, Vol. 31 Issue 3, p593-599, 7p
Abstrakt: 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. [ABSTRACT FROM AUTHOR]
Databáze: Complementary Index