Efficacy and safety of sodium RISedronate for glucocorticoid-induced OsTeoporosis with rheumaTOid arthritis (RISOTTO study): A multicentre, double-blind, randomized, placebo-controlled trial.
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.
['Fujieda|Yuichiro|Y|https://orcid.org/0000-0003-4705-341X', 'Horita|Tetsuya|T|', 'Nishimoto|Naoki|N|', 'Tanimura|Kazuhide|K|', 'Amasaki|Yoshiharu|Y|', 'Kasahara|Hideki|H|', 'Furukawa|Shin|S|', 'Takeda|Tsuyoshi|T|', 'Fukaya|Shinji|S|', 'Matsui|Kazuo|K|', 'Tsutsumi|Akito|A|', 'Furusaki|Akira|A|', 'Sagawa|Akira|A|', 'Katayama|Kou|K|', 'Takeuchi|Kaoru|K|', 'Katsumata|Kazuaki|K|', 'Kurita|Takashi|T|', 'Shane|Peter|P|', 'Kato|Masaru|M|', 'Oku|Kenji|K|', 'Yasuda|Shinsuke|S|', 'Takahata|Masahiko|M|', 'Iwasaki|Norimasa|N|', 'Atsumi|Tatsuya|T|']
D000368:Aged D001172:Arthritis, Rheumatoid D015519:Bone Density D050071:Bone Density Conservation Agents D004311:Double-Blind Method D005260:Female D005938:Glucocorticoids D006801:Humans D008159:Lumbar Vertebrae D008297:Male D008875:Middle Aged D010024:Osteoporosis D000068296:Risedronic Acid
sodium risedronate Glucocorticoid-induced osteoporosis rheumatoid arthritis randomized control study