Efficacy and safety of sodium RISedronate for glucocorticoid-induced OsTeoporosis with rheumaTOid arthritis (RISOTTO study): A multicentre, double-blind, randomized, placebo-controlled trial
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. This was a six-month randomiz...
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| creator | Fujieda, Yuichiro Horita, Tetsuya Nishimoto, Naoki Tanimura, Kazuhide Amasaki, Yoshiharu Kasahara, Hideki Furukawa, Shin Takeda, Tsuyoshi Fukaya, Shinji Matsui, Kazuo Tsutsumi, Akito Furusaki, Akira Sagawa, Akira Katayama, Kou Takeuchi, Kaoru Katsumata, Kazuaki Kurita, Takashi Shane, Peter Kato, Masaru Oku, Kenji Yasuda, Shinsuke Takahata, Masahiko Iwasaki, Norimasa Atsumi, Tatsuya |
| description | 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. 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. 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 Risedronate was effective in increasing L-BMD and was well tolerated in patients with GIO complicated with RA. |
| doi_str_mv | 10.6084/m9.figshare.13041891 |
| format | Dataset |
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The aim of this study was to explore the effectiveness and safety of Risedronate for GIO complicated with RA. 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. 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 Risedronate was effective in increasing L-BMD and was well tolerated in patients with GIO complicated with RA.</description><identifier>DOI: 10.6084/m9.figshare.13041891</identifier><language>eng</language><publisher>Taylor & Francis</publisher><subject>Biochemistry ; Biotechnology ; Cell Biology ; Ecology ; FOS: Biological sciences ; FOS: Clinical medicine ; Immunology ; Physiology</subject><creationdate>2020</creationdate><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>780,1894</link.rule.ids><linktorsrc>$$Uhttps://commons.datacite.org/doi.org/10.6084/m9.figshare.13041891$$EView_record_in_DataCite.org$$FView_record_in_$$GDataCite.org$$Hfree_for_read</linktorsrc></links><search><creatorcontrib>Fujieda, Yuichiro</creatorcontrib><creatorcontrib>Horita, Tetsuya</creatorcontrib><creatorcontrib>Nishimoto, Naoki</creatorcontrib><creatorcontrib>Tanimura, Kazuhide</creatorcontrib><creatorcontrib>Amasaki, Yoshiharu</creatorcontrib><creatorcontrib>Kasahara, Hideki</creatorcontrib><creatorcontrib>Furukawa, Shin</creatorcontrib><creatorcontrib>Takeda, Tsuyoshi</creatorcontrib><creatorcontrib>Fukaya, Shinji</creatorcontrib><creatorcontrib>Matsui, Kazuo</creatorcontrib><creatorcontrib>Tsutsumi, Akito</creatorcontrib><creatorcontrib>Furusaki, Akira</creatorcontrib><creatorcontrib>Sagawa, Akira</creatorcontrib><creatorcontrib>Katayama, Kou</creatorcontrib><creatorcontrib>Takeuchi, Kaoru</creatorcontrib><creatorcontrib>Katsumata, Kazuaki</creatorcontrib><creatorcontrib>Kurita, Takashi</creatorcontrib><creatorcontrib>Shane, Peter</creatorcontrib><creatorcontrib>Kato, Masaru</creatorcontrib><creatorcontrib>Oku, Kenji</creatorcontrib><creatorcontrib>Yasuda, Shinsuke</creatorcontrib><creatorcontrib>Takahata, Masahiko</creatorcontrib><creatorcontrib>Iwasaki, Norimasa</creatorcontrib><creatorcontrib>Atsumi, Tatsuya</creatorcontrib><title>Efficacy and safety of sodium RISedronate for glucocorticoid-induced OsTeoporosis with rheumaTOid arthritis (RISOTTO study): A multicentre, double-blind, randomized, placebo-controlled trial</title><description>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. 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. 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 Risedronate was effective in increasing L-BMD and was well tolerated in patients with GIO complicated with RA.</description><subject>Biochemistry</subject><subject>Biotechnology</subject><subject>Cell Biology</subject><subject>Ecology</subject><subject>FOS: Biological sciences</subject><subject>FOS: Clinical medicine</subject><subject>Immunology</subject><subject>Physiology</subject><fulltext>true</fulltext><rsrctype>dataset</rsrctype><creationdate>2020</creationdate><recordtype>dataset</recordtype><sourceid>PQ8</sourceid><recordid>eNo1kMtqwzAQRb3poqT9gy5m2UKcWrEdR92FkD4gYGi9N2NpFAtkK0gyxf24fltV2qxmYIZzLydJ7li22mTb4nHgK6VPvkdHK5ZnBdtydp18H5TSAsUMOErwqCjMYBV4K_U0wPvbB0lnRwwEyjo4mUlYYV3QwmqZ6lFOgiTUviF7ts567eFThx5cT9OATa0loAu90yFe7iOubpoafJjk_PAEOxgmE1k0BkdLkHbqDKWdidwluNjIDvqL4n42KKizqbDx0xoTM4PTaG6SK4XG0-3_XCTN86HZv6bH-uVtvzumkjOWYsFYKXmHtM5EWZWSdYzzqswFF2pTyrLCinGlOrWVnBPHssC8WmO-WZMsMpEvkuIPKzGg0IHas9MDurllWftrtx14e7HbXuzmP59nez4</recordid><startdate>20201002</startdate><enddate>20201002</enddate><creator>Fujieda, Yuichiro</creator><creator>Horita, Tetsuya</creator><creator>Nishimoto, Naoki</creator><creator>Tanimura, Kazuhide</creator><creator>Amasaki, Yoshiharu</creator><creator>Kasahara, Hideki</creator><creator>Furukawa, Shin</creator><creator>Takeda, Tsuyoshi</creator><creator>Fukaya, Shinji</creator><creator>Matsui, Kazuo</creator><creator>Tsutsumi, Akito</creator><creator>Furusaki, Akira</creator><creator>Sagawa, Akira</creator><creator>Katayama, Kou</creator><creator>Takeuchi, Kaoru</creator><creator>Katsumata, Kazuaki</creator><creator>Kurita, Takashi</creator><creator>Shane, Peter</creator><creator>Kato, Masaru</creator><creator>Oku, Kenji</creator><creator>Yasuda, Shinsuke</creator><creator>Takahata, Masahiko</creator><creator>Iwasaki, Norimasa</creator><creator>Atsumi, Tatsuya</creator><general>Taylor & Francis</general><scope>DYCCY</scope><scope>PQ8</scope></search><sort><creationdate>20201002</creationdate><title>Efficacy and safety of sodium RISedronate for glucocorticoid-induced OsTeoporosis with rheumaTOid arthritis (RISOTTO study): A multicentre, double-blind, randomized, placebo-controlled trial</title><author>Fujieda, Yuichiro ; Horita, Tetsuya ; Nishimoto, Naoki ; Tanimura, Kazuhide ; Amasaki, Yoshiharu ; Kasahara, Hideki ; Furukawa, Shin ; Takeda, Tsuyoshi ; Fukaya, Shinji ; Matsui, Kazuo ; Tsutsumi, Akito ; Furusaki, Akira ; Sagawa, Akira ; Katayama, Kou ; Takeuchi, Kaoru ; Katsumata, Kazuaki ; Kurita, Takashi ; Shane, Peter ; Kato, Masaru ; Oku, Kenji ; Yasuda, Shinsuke ; Takahata, Masahiko ; Iwasaki, Norimasa ; Atsumi, Tatsuya</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-d911-a4115d9bae20c575d1b199753c9cf65d57a719ffbf8d99e9a54a372a362ed40c3</frbrgroupid><rsrctype>datasets</rsrctype><prefilter>datasets</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Biochemistry</topic><topic>Biotechnology</topic><topic>Cell Biology</topic><topic>Ecology</topic><topic>FOS: Biological sciences</topic><topic>FOS: Clinical medicine</topic><topic>Immunology</topic><topic>Physiology</topic><toplevel>online_resources</toplevel><creatorcontrib>Fujieda, Yuichiro</creatorcontrib><creatorcontrib>Horita, Tetsuya</creatorcontrib><creatorcontrib>Nishimoto, Naoki</creatorcontrib><creatorcontrib>Tanimura, Kazuhide</creatorcontrib><creatorcontrib>Amasaki, Yoshiharu</creatorcontrib><creatorcontrib>Kasahara, Hideki</creatorcontrib><creatorcontrib>Furukawa, Shin</creatorcontrib><creatorcontrib>Takeda, Tsuyoshi</creatorcontrib><creatorcontrib>Fukaya, Shinji</creatorcontrib><creatorcontrib>Matsui, Kazuo</creatorcontrib><creatorcontrib>Tsutsumi, Akito</creatorcontrib><creatorcontrib>Furusaki, Akira</creatorcontrib><creatorcontrib>Sagawa, Akira</creatorcontrib><creatorcontrib>Katayama, Kou</creatorcontrib><creatorcontrib>Takeuchi, Kaoru</creatorcontrib><creatorcontrib>Katsumata, Kazuaki</creatorcontrib><creatorcontrib>Kurita, Takashi</creatorcontrib><creatorcontrib>Shane, Peter</creatorcontrib><creatorcontrib>Kato, Masaru</creatorcontrib><creatorcontrib>Oku, Kenji</creatorcontrib><creatorcontrib>Yasuda, Shinsuke</creatorcontrib><creatorcontrib>Takahata, Masahiko</creatorcontrib><creatorcontrib>Iwasaki, Norimasa</creatorcontrib><creatorcontrib>Atsumi, Tatsuya</creatorcontrib><collection>DataCite (Open Access)</collection><collection>DataCite</collection></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext_linktorsrc</fulltext></delivery><addata><au>Fujieda, Yuichiro</au><au>Horita, Tetsuya</au><au>Nishimoto, Naoki</au><au>Tanimura, Kazuhide</au><au>Amasaki, Yoshiharu</au><au>Kasahara, Hideki</au><au>Furukawa, Shin</au><au>Takeda, Tsuyoshi</au><au>Fukaya, Shinji</au><au>Matsui, Kazuo</au><au>Tsutsumi, Akito</au><au>Furusaki, Akira</au><au>Sagawa, Akira</au><au>Katayama, Kou</au><au>Takeuchi, Kaoru</au><au>Katsumata, Kazuaki</au><au>Kurita, Takashi</au><au>Shane, Peter</au><au>Kato, Masaru</au><au>Oku, Kenji</au><au>Yasuda, Shinsuke</au><au>Takahata, Masahiko</au><au>Iwasaki, Norimasa</au><au>Atsumi, Tatsuya</au><format>book</format><genre>unknown</genre><ristype>DATA</ristype><title>Efficacy and safety of sodium RISedronate for glucocorticoid-induced OsTeoporosis with rheumaTOid arthritis (RISOTTO study): A multicentre, double-blind, randomized, placebo-controlled trial</title><date>2020-10-02</date><risdate>2020</risdate><abstract>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. 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. 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 Risedronate was effective in increasing L-BMD and was well tolerated in patients with GIO complicated with RA.</abstract><pub>Taylor & Francis</pub><doi>10.6084/m9.figshare.13041891</doi><oa>free_for_read</oa></addata></record> |
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| title | Efficacy and safety of sodium RISedronate for glucocorticoid-induced OsTeoporosis with rheumaTOid arthritis (RISOTTO study): A multicentre, double-blind, randomized, placebo-controlled trial |
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