Efficacy and safety of romosozumab: a meta-analysis of placebo-controlled trials
Introduction We aimed to comprehensively compile placebo-controlled trials on the efficacy and safety of romosozumab (210 mg, subcutaneously, once monthly) in postmenopausal women and men with osteoporosis. Materials and methods PubMed, Google Scholar, and ClinicalTrials.gov were searched for releva...
Ausführliche Beschreibung
Gespeichert in:
| Autor*in: |
Kobayashi, Takaomi [verfasserIn] Hara, Megumi [verfasserIn] Shimanoe, Chisato [verfasserIn] Morimoto, Tadatsugu [verfasserIn] Masaaki, Mawatari [verfasserIn] Ito, Koji [verfasserIn] Shimazaki, Takafumi [verfasserIn] |
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| Format: |
E-Artikel |
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| Sprache: |
Englisch |
| Erschienen: |
2024 |
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| Anmerkung: |
© The Japanese Society Bone and Mineral Research 2024. Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law. |
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| Übergeordnetes Werk: |
Enthalten in: Journal of bone and mineral metabolism - Springer Nature Singapore, 1995, 42(2024), 5 vom: 08. Juli, Seite 492-502 |
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| Übergeordnetes Werk: |
volume:42 ; year:2024 ; number:5 ; day:08 ; month:07 ; pages:492-502 |
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| DOI / URN: |
10.1007/s00774-024-01531-5 |
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SPR057682453 |
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| 520 | |a Introduction We aimed to comprehensively compile placebo-controlled trials on the efficacy and safety of romosozumab (210 mg, subcutaneously, once monthly) in postmenopausal women and men with osteoporosis. Materials and methods PubMed, Google Scholar, and ClinicalTrials.gov were searched for relevant placebo-controlled trials (as of January 1, 2024). Percent change in bone mineral density (BMD), falls, fractures, and adverse events (AEs) after drug administration were collected. Risk ratios (RRs) and mean differences (MDs) with 95% confidence intervals (CIs) were calculated. Results Six trials (7990 patients; follow-up period, 6–12 months) were included. Compared with placebo, romosozumab significantly increased lumbar spine BMD (MD = 12.69; 95% CI 11.10–14.29), total hip BMD (MD = 4.42; 95% CI 3.03–5.80), and femoral neck BMD (MD = 3.99; 95% CI 2.42–5.57) at 12 months. Romosozumab significantly decreased falls (RR = 0.80; 95% CI 0.68–0.93) and major osteoporotic fractures (RR = 0.37; 95% CI 0.25–0.54), but increased injection-site reactions (RR = 1.83; 95% CI 1.46–2.30) within 12 months. No significant differences were observed in other AEs (including cardiovascular AEs) within 12 months. Conclusion Romosozumab treatment resulted in a significant BMD gain, reduced falls and major osteoporotic fractures. It was generally well-tolerated, including the cardiovascular aspects. However, clinicians should consider the occurrence of minor AEs (e.g., injection-site reactions). | ||
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| 700 | 1 | |a Shimazaki, Takafumi |e verfasserin |4 aut | |
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10.1007/s00774-024-01531-5 doi (DE-627)SPR057682453 (SPR)s00774-024-01531-5-e DE-627 ger DE-627 rakwb eng 610 VZ 610 VZ 42.17 bkl 42.15 bkl Kobayashi, Takaomi verfasserin (orcid)0000-0002-2319-5440 aut Efficacy and safety of romosozumab: a meta-analysis of placebo-controlled trials 2024 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Japanese Society Bone and Mineral Research 2024. Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law. Introduction We aimed to comprehensively compile placebo-controlled trials on the efficacy and safety of romosozumab (210 mg, subcutaneously, once monthly) in postmenopausal women and men with osteoporosis. Materials and methods PubMed, Google Scholar, and ClinicalTrials.gov were searched for relevant placebo-controlled trials (as of January 1, 2024). Percent change in bone mineral density (BMD), falls, fractures, and adverse events (AEs) after drug administration were collected. Risk ratios (RRs) and mean differences (MDs) with 95% confidence intervals (CIs) were calculated. Results Six trials (7990 patients; follow-up period, 6–12 months) were included. Compared with placebo, romosozumab significantly increased lumbar spine BMD (MD = 12.69; 95% CI 11.10–14.29), total hip BMD (MD = 4.42; 95% CI 3.03–5.80), and femoral neck BMD (MD = 3.99; 95% CI 2.42–5.57) at 12 months. Romosozumab significantly decreased falls (RR = 0.80; 95% CI 0.68–0.93) and major osteoporotic fractures (RR = 0.37; 95% CI 0.25–0.54), but increased injection-site reactions (RR = 1.83; 95% CI 1.46–2.30) within 12 months. No significant differences were observed in other AEs (including cardiovascular AEs) within 12 months. Conclusion Romosozumab treatment resulted in a significant BMD gain, reduced falls and major osteoporotic fractures. It was generally well-tolerated, including the cardiovascular aspects. However, clinicians should consider the occurrence of minor AEs (e.g., injection-site reactions). Romosozumab (dpeaa)DE-He213 Bone mineral density (dpeaa)DE-He213 Fall (dpeaa)DE-He213 Fracture (dpeaa)DE-He213 Adverse event (dpeaa)DE-He213 Hara, Megumi verfasserin aut Shimanoe, Chisato verfasserin aut Morimoto, Tadatsugu verfasserin aut Masaaki, Mawatari verfasserin aut Ito, Koji verfasserin aut Shimazaki, Takafumi verfasserin aut Enthalten in Journal of bone and mineral metabolism Springer Nature Singapore, 1995 42(2024), 5 vom: 08. Juli, Seite 492-502 (DE-627)300185405 (DE-600)1481600-3 1435-5604 nnns volume:42 year:2024 number:5 day:08 month:07 pages:492-502 https://dx.doi.org/10.1007/s00774-024-01531-5 X:SPRINGER Resolving-System lizenzpflichtig Volltext SYSFLAG_0 GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_69 GBV_ILN_70 GBV_ILN_72 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_120 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_152 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_250 GBV_ILN_267 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_636 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2106 GBV_ILN_2107 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2446 GBV_ILN_2470 GBV_ILN_2472 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_2548 GBV_ILN_2574 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4328 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 42.17 VZ 42.15 VZ AR 42 2024 5 08 07 492-502 |
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10.1007/s00774-024-01531-5 doi (DE-627)SPR057682453 (SPR)s00774-024-01531-5-e DE-627 ger DE-627 rakwb eng 610 VZ 610 VZ 42.17 bkl 42.15 bkl Kobayashi, Takaomi verfasserin (orcid)0000-0002-2319-5440 aut Efficacy and safety of romosozumab: a meta-analysis of placebo-controlled trials 2024 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Japanese Society Bone and Mineral Research 2024. Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law. Introduction We aimed to comprehensively compile placebo-controlled trials on the efficacy and safety of romosozumab (210 mg, subcutaneously, once monthly) in postmenopausal women and men with osteoporosis. Materials and methods PubMed, Google Scholar, and ClinicalTrials.gov were searched for relevant placebo-controlled trials (as of January 1, 2024). Percent change in bone mineral density (BMD), falls, fractures, and adverse events (AEs) after drug administration were collected. Risk ratios (RRs) and mean differences (MDs) with 95% confidence intervals (CIs) were calculated. Results Six trials (7990 patients; follow-up period, 6–12 months) were included. Compared with placebo, romosozumab significantly increased lumbar spine BMD (MD = 12.69; 95% CI 11.10–14.29), total hip BMD (MD = 4.42; 95% CI 3.03–5.80), and femoral neck BMD (MD = 3.99; 95% CI 2.42–5.57) at 12 months. Romosozumab significantly decreased falls (RR = 0.80; 95% CI 0.68–0.93) and major osteoporotic fractures (RR = 0.37; 95% CI 0.25–0.54), but increased injection-site reactions (RR = 1.83; 95% CI 1.46–2.30) within 12 months. No significant differences were observed in other AEs (including cardiovascular AEs) within 12 months. Conclusion Romosozumab treatment resulted in a significant BMD gain, reduced falls and major osteoporotic fractures. It was generally well-tolerated, including the cardiovascular aspects. However, clinicians should consider the occurrence of minor AEs (e.g., injection-site reactions). Romosozumab (dpeaa)DE-He213 Bone mineral density (dpeaa)DE-He213 Fall (dpeaa)DE-He213 Fracture (dpeaa)DE-He213 Adverse event (dpeaa)DE-He213 Hara, Megumi verfasserin aut Shimanoe, Chisato verfasserin aut Morimoto, Tadatsugu verfasserin aut Masaaki, Mawatari verfasserin aut Ito, Koji verfasserin aut Shimazaki, Takafumi verfasserin aut Enthalten in Journal of bone and mineral metabolism Springer Nature Singapore, 1995 42(2024), 5 vom: 08. Juli, Seite 492-502 (DE-627)300185405 (DE-600)1481600-3 1435-5604 nnns volume:42 year:2024 number:5 day:08 month:07 pages:492-502 https://dx.doi.org/10.1007/s00774-024-01531-5 X:SPRINGER Resolving-System lizenzpflichtig Volltext SYSFLAG_0 GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_69 GBV_ILN_70 GBV_ILN_72 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_120 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_152 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_250 GBV_ILN_267 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_636 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2106 GBV_ILN_2107 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2446 GBV_ILN_2470 GBV_ILN_2472 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_2548 GBV_ILN_2574 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4328 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 42.17 VZ 42.15 VZ AR 42 2024 5 08 07 492-502 |
| allfields_unstemmed |
10.1007/s00774-024-01531-5 doi (DE-627)SPR057682453 (SPR)s00774-024-01531-5-e DE-627 ger DE-627 rakwb eng 610 VZ 610 VZ 42.17 bkl 42.15 bkl Kobayashi, Takaomi verfasserin (orcid)0000-0002-2319-5440 aut Efficacy and safety of romosozumab: a meta-analysis of placebo-controlled trials 2024 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Japanese Society Bone and Mineral Research 2024. Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law. Introduction We aimed to comprehensively compile placebo-controlled trials on the efficacy and safety of romosozumab (210 mg, subcutaneously, once monthly) in postmenopausal women and men with osteoporosis. Materials and methods PubMed, Google Scholar, and ClinicalTrials.gov were searched for relevant placebo-controlled trials (as of January 1, 2024). Percent change in bone mineral density (BMD), falls, fractures, and adverse events (AEs) after drug administration were collected. Risk ratios (RRs) and mean differences (MDs) with 95% confidence intervals (CIs) were calculated. Results Six trials (7990 patients; follow-up period, 6–12 months) were included. Compared with placebo, romosozumab significantly increased lumbar spine BMD (MD = 12.69; 95% CI 11.10–14.29), total hip BMD (MD = 4.42; 95% CI 3.03–5.80), and femoral neck BMD (MD = 3.99; 95% CI 2.42–5.57) at 12 months. Romosozumab significantly decreased falls (RR = 0.80; 95% CI 0.68–0.93) and major osteoporotic fractures (RR = 0.37; 95% CI 0.25–0.54), but increased injection-site reactions (RR = 1.83; 95% CI 1.46–2.30) within 12 months. No significant differences were observed in other AEs (including cardiovascular AEs) within 12 months. Conclusion Romosozumab treatment resulted in a significant BMD gain, reduced falls and major osteoporotic fractures. It was generally well-tolerated, including the cardiovascular aspects. However, clinicians should consider the occurrence of minor AEs (e.g., injection-site reactions). Romosozumab (dpeaa)DE-He213 Bone mineral density (dpeaa)DE-He213 Fall (dpeaa)DE-He213 Fracture (dpeaa)DE-He213 Adverse event (dpeaa)DE-He213 Hara, Megumi verfasserin aut Shimanoe, Chisato verfasserin aut Morimoto, Tadatsugu verfasserin aut Masaaki, Mawatari verfasserin aut Ito, Koji verfasserin aut Shimazaki, Takafumi verfasserin aut Enthalten in Journal of bone and mineral metabolism Springer Nature Singapore, 1995 42(2024), 5 vom: 08. Juli, Seite 492-502 (DE-627)300185405 (DE-600)1481600-3 1435-5604 nnns volume:42 year:2024 number:5 day:08 month:07 pages:492-502 https://dx.doi.org/10.1007/s00774-024-01531-5 X:SPRINGER Resolving-System lizenzpflichtig Volltext SYSFLAG_0 GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_69 GBV_ILN_70 GBV_ILN_72 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_120 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_152 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_250 GBV_ILN_267 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_636 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2106 GBV_ILN_2107 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2446 GBV_ILN_2470 GBV_ILN_2472 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_2548 GBV_ILN_2574 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4328 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 42.17 VZ 42.15 VZ AR 42 2024 5 08 07 492-502 |
| allfieldsGer |
10.1007/s00774-024-01531-5 doi (DE-627)SPR057682453 (SPR)s00774-024-01531-5-e DE-627 ger DE-627 rakwb eng 610 VZ 610 VZ 42.17 bkl 42.15 bkl Kobayashi, Takaomi verfasserin (orcid)0000-0002-2319-5440 aut Efficacy and safety of romosozumab: a meta-analysis of placebo-controlled trials 2024 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Japanese Society Bone and Mineral Research 2024. Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law. Introduction We aimed to comprehensively compile placebo-controlled trials on the efficacy and safety of romosozumab (210 mg, subcutaneously, once monthly) in postmenopausal women and men with osteoporosis. Materials and methods PubMed, Google Scholar, and ClinicalTrials.gov were searched for relevant placebo-controlled trials (as of January 1, 2024). Percent change in bone mineral density (BMD), falls, fractures, and adverse events (AEs) after drug administration were collected. Risk ratios (RRs) and mean differences (MDs) with 95% confidence intervals (CIs) were calculated. Results Six trials (7990 patients; follow-up period, 6–12 months) were included. Compared with placebo, romosozumab significantly increased lumbar spine BMD (MD = 12.69; 95% CI 11.10–14.29), total hip BMD (MD = 4.42; 95% CI 3.03–5.80), and femoral neck BMD (MD = 3.99; 95% CI 2.42–5.57) at 12 months. Romosozumab significantly decreased falls (RR = 0.80; 95% CI 0.68–0.93) and major osteoporotic fractures (RR = 0.37; 95% CI 0.25–0.54), but increased injection-site reactions (RR = 1.83; 95% CI 1.46–2.30) within 12 months. No significant differences were observed in other AEs (including cardiovascular AEs) within 12 months. Conclusion Romosozumab treatment resulted in a significant BMD gain, reduced falls and major osteoporotic fractures. It was generally well-tolerated, including the cardiovascular aspects. However, clinicians should consider the occurrence of minor AEs (e.g., injection-site reactions). Romosozumab (dpeaa)DE-He213 Bone mineral density (dpeaa)DE-He213 Fall (dpeaa)DE-He213 Fracture (dpeaa)DE-He213 Adverse event (dpeaa)DE-He213 Hara, Megumi verfasserin aut Shimanoe, Chisato verfasserin aut Morimoto, Tadatsugu verfasserin aut Masaaki, Mawatari verfasserin aut Ito, Koji verfasserin aut Shimazaki, Takafumi verfasserin aut Enthalten in Journal of bone and mineral metabolism Springer Nature Singapore, 1995 42(2024), 5 vom: 08. Juli, Seite 492-502 (DE-627)300185405 (DE-600)1481600-3 1435-5604 nnns volume:42 year:2024 number:5 day:08 month:07 pages:492-502 https://dx.doi.org/10.1007/s00774-024-01531-5 X:SPRINGER Resolving-System lizenzpflichtig Volltext SYSFLAG_0 GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_69 GBV_ILN_70 GBV_ILN_72 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_120 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_152 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_250 GBV_ILN_267 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_636 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2106 GBV_ILN_2107 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2446 GBV_ILN_2470 GBV_ILN_2472 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_2548 GBV_ILN_2574 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4328 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 42.17 VZ 42.15 VZ AR 42 2024 5 08 07 492-502 |
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10.1007/s00774-024-01531-5 doi (DE-627)SPR057682453 (SPR)s00774-024-01531-5-e DE-627 ger DE-627 rakwb eng 610 VZ 610 VZ 42.17 bkl 42.15 bkl Kobayashi, Takaomi verfasserin (orcid)0000-0002-2319-5440 aut Efficacy and safety of romosozumab: a meta-analysis of placebo-controlled trials 2024 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Japanese Society Bone and Mineral Research 2024. Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law. Introduction We aimed to comprehensively compile placebo-controlled trials on the efficacy and safety of romosozumab (210 mg, subcutaneously, once monthly) in postmenopausal women and men with osteoporosis. Materials and methods PubMed, Google Scholar, and ClinicalTrials.gov were searched for relevant placebo-controlled trials (as of January 1, 2024). Percent change in bone mineral density (BMD), falls, fractures, and adverse events (AEs) after drug administration were collected. Risk ratios (RRs) and mean differences (MDs) with 95% confidence intervals (CIs) were calculated. Results Six trials (7990 patients; follow-up period, 6–12 months) were included. Compared with placebo, romosozumab significantly increased lumbar spine BMD (MD = 12.69; 95% CI 11.10–14.29), total hip BMD (MD = 4.42; 95% CI 3.03–5.80), and femoral neck BMD (MD = 3.99; 95% CI 2.42–5.57) at 12 months. Romosozumab significantly decreased falls (RR = 0.80; 95% CI 0.68–0.93) and major osteoporotic fractures (RR = 0.37; 95% CI 0.25–0.54), but increased injection-site reactions (RR = 1.83; 95% CI 1.46–2.30) within 12 months. No significant differences were observed in other AEs (including cardiovascular AEs) within 12 months. Conclusion Romosozumab treatment resulted in a significant BMD gain, reduced falls and major osteoporotic fractures. It was generally well-tolerated, including the cardiovascular aspects. However, clinicians should consider the occurrence of minor AEs (e.g., injection-site reactions). Romosozumab (dpeaa)DE-He213 Bone mineral density (dpeaa)DE-He213 Fall (dpeaa)DE-He213 Fracture (dpeaa)DE-He213 Adverse event (dpeaa)DE-He213 Hara, Megumi verfasserin aut Shimanoe, Chisato verfasserin aut Morimoto, Tadatsugu verfasserin aut Masaaki, Mawatari verfasserin aut Ito, Koji verfasserin aut Shimazaki, Takafumi verfasserin aut Enthalten in Journal of bone and mineral metabolism Springer Nature Singapore, 1995 42(2024), 5 vom: 08. Juli, Seite 492-502 (DE-627)300185405 (DE-600)1481600-3 1435-5604 nnns volume:42 year:2024 number:5 day:08 month:07 pages:492-502 https://dx.doi.org/10.1007/s00774-024-01531-5 X:SPRINGER Resolving-System lizenzpflichtig Volltext SYSFLAG_0 GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_69 GBV_ILN_70 GBV_ILN_72 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_120 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_152 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_250 GBV_ILN_267 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_636 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2106 GBV_ILN_2107 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2446 GBV_ILN_2470 GBV_ILN_2472 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_2548 GBV_ILN_2574 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4328 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 42.17 VZ 42.15 VZ AR 42 2024 5 08 07 492-502 |
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Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law.</subfield></datafield><datafield tag="520" ind1=" " ind2=" "><subfield code="a">Introduction We aimed to comprehensively compile placebo-controlled trials on the efficacy and safety of romosozumab (210 mg, subcutaneously, once monthly) in postmenopausal women and men with osteoporosis. Materials and methods PubMed, Google Scholar, and ClinicalTrials.gov were searched for relevant placebo-controlled trials (as of January 1, 2024). Percent change in bone mineral density (BMD), falls, fractures, and adverse events (AEs) after drug administration were collected. Risk ratios (RRs) and mean differences (MDs) with 95% confidence intervals (CIs) were calculated. 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Kobayashi, Takaomi |
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efficacy and safety of romosozumab: a meta-analysis of placebo-controlled trials |
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Efficacy and safety of romosozumab: a meta-analysis of placebo-controlled trials |
| abstract |
Introduction We aimed to comprehensively compile placebo-controlled trials on the efficacy and safety of romosozumab (210 mg, subcutaneously, once monthly) in postmenopausal women and men with osteoporosis. Materials and methods PubMed, Google Scholar, and ClinicalTrials.gov were searched for relevant placebo-controlled trials (as of January 1, 2024). Percent change in bone mineral density (BMD), falls, fractures, and adverse events (AEs) after drug administration were collected. Risk ratios (RRs) and mean differences (MDs) with 95% confidence intervals (CIs) were calculated. Results Six trials (7990 patients; follow-up period, 6–12 months) were included. Compared with placebo, romosozumab significantly increased lumbar spine BMD (MD = 12.69; 95% CI 11.10–14.29), total hip BMD (MD = 4.42; 95% CI 3.03–5.80), and femoral neck BMD (MD = 3.99; 95% CI 2.42–5.57) at 12 months. Romosozumab significantly decreased falls (RR = 0.80; 95% CI 0.68–0.93) and major osteoporotic fractures (RR = 0.37; 95% CI 0.25–0.54), but increased injection-site reactions (RR = 1.83; 95% CI 1.46–2.30) within 12 months. No significant differences were observed in other AEs (including cardiovascular AEs) within 12 months. Conclusion Romosozumab treatment resulted in a significant BMD gain, reduced falls and major osteoporotic fractures. It was generally well-tolerated, including the cardiovascular aspects. However, clinicians should consider the occurrence of minor AEs (e.g., injection-site reactions). © The Japanese Society Bone and Mineral Research 2024. Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law. |
| abstractGer |
Introduction We aimed to comprehensively compile placebo-controlled trials on the efficacy and safety of romosozumab (210 mg, subcutaneously, once monthly) in postmenopausal women and men with osteoporosis. Materials and methods PubMed, Google Scholar, and ClinicalTrials.gov were searched for relevant placebo-controlled trials (as of January 1, 2024). Percent change in bone mineral density (BMD), falls, fractures, and adverse events (AEs) after drug administration were collected. Risk ratios (RRs) and mean differences (MDs) with 95% confidence intervals (CIs) were calculated. Results Six trials (7990 patients; follow-up period, 6–12 months) were included. Compared with placebo, romosozumab significantly increased lumbar spine BMD (MD = 12.69; 95% CI 11.10–14.29), total hip BMD (MD = 4.42; 95% CI 3.03–5.80), and femoral neck BMD (MD = 3.99; 95% CI 2.42–5.57) at 12 months. Romosozumab significantly decreased falls (RR = 0.80; 95% CI 0.68–0.93) and major osteoporotic fractures (RR = 0.37; 95% CI 0.25–0.54), but increased injection-site reactions (RR = 1.83; 95% CI 1.46–2.30) within 12 months. No significant differences were observed in other AEs (including cardiovascular AEs) within 12 months. Conclusion Romosozumab treatment resulted in a significant BMD gain, reduced falls and major osteoporotic fractures. It was generally well-tolerated, including the cardiovascular aspects. However, clinicians should consider the occurrence of minor AEs (e.g., injection-site reactions). © The Japanese Society Bone and Mineral Research 2024. Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law. |
| abstract_unstemmed |
Introduction We aimed to comprehensively compile placebo-controlled trials on the efficacy and safety of romosozumab (210 mg, subcutaneously, once monthly) in postmenopausal women and men with osteoporosis. Materials and methods PubMed, Google Scholar, and ClinicalTrials.gov were searched for relevant placebo-controlled trials (as of January 1, 2024). Percent change in bone mineral density (BMD), falls, fractures, and adverse events (AEs) after drug administration were collected. Risk ratios (RRs) and mean differences (MDs) with 95% confidence intervals (CIs) were calculated. Results Six trials (7990 patients; follow-up period, 6–12 months) were included. Compared with placebo, romosozumab significantly increased lumbar spine BMD (MD = 12.69; 95% CI 11.10–14.29), total hip BMD (MD = 4.42; 95% CI 3.03–5.80), and femoral neck BMD (MD = 3.99; 95% CI 2.42–5.57) at 12 months. Romosozumab significantly decreased falls (RR = 0.80; 95% CI 0.68–0.93) and major osteoporotic fractures (RR = 0.37; 95% CI 0.25–0.54), but increased injection-site reactions (RR = 1.83; 95% CI 1.46–2.30) within 12 months. No significant differences were observed in other AEs (including cardiovascular AEs) within 12 months. Conclusion Romosozumab treatment resulted in a significant BMD gain, reduced falls and major osteoporotic fractures. It was generally well-tolerated, including the cardiovascular aspects. However, clinicians should consider the occurrence of minor AEs (e.g., injection-site reactions). © The Japanese Society Bone and Mineral Research 2024. Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law. |
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<?xml version="1.0" encoding="UTF-8"?><collection xmlns="http://www.loc.gov/MARC21/slim"><record><leader>01000naa a22002652 4500</leader><controlfield tag="001">SPR057682453</controlfield><controlfield tag="003">DE-627</controlfield><controlfield tag="005">20241006064637.0</controlfield><controlfield tag="007">cr uuu---uuuuu</controlfield><controlfield tag="008">241006s2024 xx |||||o 00| ||eng c</controlfield><datafield tag="024" ind1="7" ind2=" "><subfield code="a">10.1007/s00774-024-01531-5</subfield><subfield code="2">doi</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(DE-627)SPR057682453</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(SPR)s00774-024-01531-5-e</subfield></datafield><datafield tag="040" ind1=" " ind2=" "><subfield code="a">DE-627</subfield><subfield code="b">ger</subfield><subfield code="c">DE-627</subfield><subfield code="e">rakwb</subfield></datafield><datafield tag="041" ind1=" " ind2=" "><subfield code="a">eng</subfield></datafield><datafield tag="082" ind1="0" ind2="4"><subfield code="a">610</subfield><subfield code="q">VZ</subfield></datafield><datafield tag="082" ind1="0" ind2="4"><subfield code="a">610</subfield><subfield code="q">VZ</subfield></datafield><datafield tag="084" ind1=" " ind2=" "><subfield code="a">42.17</subfield><subfield code="2">bkl</subfield></datafield><datafield tag="084" ind1=" " ind2=" "><subfield code="a">42.15</subfield><subfield code="2">bkl</subfield></datafield><datafield tag="100" ind1="1" ind2=" "><subfield code="a">Kobayashi, Takaomi</subfield><subfield code="e">verfasserin</subfield><subfield code="0">(orcid)0000-0002-2319-5440</subfield><subfield code="4">aut</subfield></datafield><datafield tag="245" ind1="1" ind2="0"><subfield code="a">Efficacy and safety of romosozumab: a meta-analysis of placebo-controlled trials</subfield></datafield><datafield tag="264" ind1=" " ind2="1"><subfield code="c">2024</subfield></datafield><datafield tag="336" ind1=" " ind2=" "><subfield code="a">Text</subfield><subfield code="b">txt</subfield><subfield code="2">rdacontent</subfield></datafield><datafield tag="337" ind1=" " ind2=" "><subfield code="a">Computermedien</subfield><subfield code="b">c</subfield><subfield code="2">rdamedia</subfield></datafield><datafield tag="338" ind1=" " ind2=" "><subfield code="a">Online-Ressource</subfield><subfield code="b">cr</subfield><subfield code="2">rdacarrier</subfield></datafield><datafield tag="500" ind1=" " ind2=" "><subfield code="a">© The Japanese Society Bone and Mineral Research 2024. Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law.</subfield></datafield><datafield tag="520" ind1=" " ind2=" "><subfield code="a">Introduction We aimed to comprehensively compile placebo-controlled trials on the efficacy and safety of romosozumab (210 mg, subcutaneously, once monthly) in postmenopausal women and men with osteoporosis. Materials and methods PubMed, Google Scholar, and ClinicalTrials.gov were searched for relevant placebo-controlled trials (as of January 1, 2024). Percent change in bone mineral density (BMD), falls, fractures, and adverse events (AEs) after drug administration were collected. Risk ratios (RRs) and mean differences (MDs) with 95% confidence intervals (CIs) were calculated. Results Six trials (7990 patients; follow-up period, 6–12 months) were included. Compared with placebo, romosozumab significantly increased lumbar spine BMD (MD = 12.69; 95% CI 11.10–14.29), total hip BMD (MD = 4.42; 95% CI 3.03–5.80), and femoral neck BMD (MD = 3.99; 95% CI 2.42–5.57) at 12 months. Romosozumab significantly decreased falls (RR = 0.80; 95% CI 0.68–0.93) and major osteoporotic fractures (RR = 0.37; 95% CI 0.25–0.54), but increased injection-site reactions (RR = 1.83; 95% CI 1.46–2.30) within 12 months. No significant differences were observed in other AEs (including cardiovascular AEs) within 12 months. Conclusion Romosozumab treatment resulted in a significant BMD gain, reduced falls and major osteoporotic fractures. It was generally well-tolerated, including the cardiovascular aspects. 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