WEKO3
アイテム
{"_buckets": {"deposit": "16384e3d-27be-41c7-a7e2-6f70a176f0ad"}, "_deposit": {"created_by": 2, "id": "6829", "owners": [2], "pid": {"revision_id": 0, "type": "depid", "value": "6829"}, "status": "published"}, "_oai": {"id": "oai:nagasaki-u.repo.nii.ac.jp:00006829", "sets": ["9"]}, "author_link": ["28603", "28608", "28604", "28609", "28607", "28606", "28605"], "item_2_biblio_info_6": {"attribute_name": "書誌情報", "attribute_value_mlt": [{"bibliographicIssueDates": {"bibliographicIssueDate": "2013-08", "bibliographicIssueDateType": "Issued"}, "bibliographicIssueNumber": "2", "bibliographicPageEnd": "146", "bibliographicPageStart": "137", "bibliographicVolumeNumber": "93", "bibliographic_titles": [{"bibliographic_title": "Calcified Tissue International"}]}]}, "item_2_description_4": {"attribute_name": "抄録", "attribute_value_mlt": [{"subitem_description": "This randomized, double-blind study assessed the antifracture efficacy and safety of intermittent intravenous (IV) ibandronate versus oral daily risedronate in Japanese patients with primary osteoporosis. Ambulatory patients aged ≥60 years were randomized to receive 0.5 or 1 mg/month IV ibandronate plus oral daily placebo or 2.5 mg/day oral risedronate, the licensed dose in Japan, plus IV placebo. The primary end point was noninferiority of ibandronate versus risedronate for first new or worsening vertebral fracture over 3 years. A total of 1,265 patients were randomized. A total of 1,134 patients formed the per-protocol set. Both ibandronate doses were noninferior to risedronate: 0.5 mg, hazard ratio (HR) 1.09 [95 % confidence interval (CI) 0.77-1.54]; 1 mg, HR 0.88 (95 % CI 0.61-1.27). The rate of first new vertebral fracture over 3 years was 16.8 % (95 % CI 12.8-20.8) for 0.5 mg ibandronate, 11.6 % (95 % CI 8.2-15.0) for 1 mg ibandronate, and 13.2 % (95 % CI 9.6-16.9) for risedronate. Significant increases in bone mineral density relative to baseline were observed with all treatments after 6 months, with substantial reductions in bone turnover markers after 3 months. Greatest efficacy was obtained with 1 mg ibandronate. Analyses in women only showed similar results to the overall population. No new safety concerns were identified. This study demonstrated the noninferiority of IV ibandronate to the licensed Japanese dose of oral risedronate and suggested that 1 mg/month is an effective dose in Japanese patients with primary osteoporosis.", "subitem_description_type": "Abstract"}]}, "item_2_description_63": {"attribute_name": "引用", "attribute_value_mlt": [{"subitem_description": "Calcified Tissue International, 93(2), pp.137-146; 2013", "subitem_description_type": "Other"}]}, "item_2_publisher_33": {"attribute_name": "出版者", "attribute_value_mlt": [{"subitem_publisher": "Springer New York"}]}, "item_2_relation_12": {"attribute_name": "DOI", "attribute_value_mlt": [{"subitem_relation_type": "isIdenticalTo", "subitem_relation_type_id": {"subitem_relation_type_id_text": "10.1007/s00223-013-9734-6", "subitem_relation_type_select": "DOI"}}]}, "item_2_rights_13": {"attribute_name": "権利", "attribute_value_mlt": [{"subitem_rights": "© The Author(s) 2013. This article is published with open access at Springerlink.com"}]}, "item_2_source_id_7": {"attribute_name": "ISSN", "attribute_value_mlt": [{"subitem_source_identifier": "0171967X", "subitem_source_identifier_type": "ISSN"}]}, "item_2_source_id_8": {"attribute_name": "EISSN", "attribute_value_mlt": [{"subitem_source_identifier": "14320827", "subitem_source_identifier_type": "ISSN"}]}, "item_2_version_type_16": {"attribute_name": "著者版フラグ", "attribute_value_mlt": [{"subitem_version_resource": "http://purl.org/coar/version/c_970fb48d4fbd8a85", "subitem_version_type": "VoR"}]}, "item_creator": {"attribute_name": "著者", "attribute_type": "creator", "attribute_value_mlt": [{"creatorNames": [{"creatorName": "Nakamura, Toshitaka"}], "nameIdentifiers": [{"nameIdentifier": "28603", "nameIdentifierScheme": "WEKO"}]}, {"creatorNames": [{"creatorName": "Nakano, Tetsuo"}], "nameIdentifiers": [{"nameIdentifier": "28604", "nameIdentifierScheme": "WEKO"}]}, {"creatorNames": [{"creatorName": "Ito, Masako"}], "nameIdentifiers": [{"nameIdentifier": "28605", "nameIdentifierScheme": "WEKO"}]}, {"creatorNames": [{"creatorName": "Hagino, Hiroshi"}], "nameIdentifiers": [{"nameIdentifier": "28606", "nameIdentifierScheme": "WEKO"}]}, {"creatorNames": [{"creatorName": "Hashimoto, Junko"}], "nameIdentifiers": [{"nameIdentifier": "28607", "nameIdentifierScheme": "WEKO"}]}, {"creatorNames": [{"creatorName": "Tobinai, Masato"}], "nameIdentifiers": [{"nameIdentifier": "28608", "nameIdentifierScheme": "WEKO"}]}, {"creatorNames": [{"creatorName": "Mizunuma, Hideki"}], "nameIdentifiers": [{"nameIdentifier": "28609", "nameIdentifierScheme": "WEKO"}]}]}, "item_files": {"attribute_name": "ファイル情報", "attribute_type": "file", "attribute_value_mlt": [{"accessrole": "open_date", "date": [{"dateType": "Available", "dateValue": "2020-12-21"}], "displaytype": "detail", "download_preview_message": "", "file_order": 0, "filename": "CTI93_137.pdf", "filesize": [{"value": "587.5 kB"}], "format": "application/pdf", "future_date_message": "", "is_thumbnail": false, "licensetype": "license_free", "mimetype": "application/pdf", "size": 587500.0, "url": {"label": "CTI93_137.pdf", "url": "https://nagasaki-u.repo.nii.ac.jp/record/6829/files/CTI93_137.pdf"}, "version_id": "a08da6e1-b906-4f20-ad09-3e75157b8c6e"}]}, "item_keyword": {"attribute_name": "キーワード", "attribute_value_mlt": [{"subitem_subject": "Ibandronate", "subitem_subject_scheme": "Other"}, {"subitem_subject": "Intravenous", "subitem_subject_scheme": "Other"}, {"subitem_subject": "Osteoporosis", "subitem_subject_scheme": "Other"}, {"subitem_subject": "Risedronate", "subitem_subject_scheme": "Other"}, {"subitem_subject": "Vertebral fracture", "subitem_subject_scheme": "Other"}]}, "item_language": {"attribute_name": "言語", "attribute_value_mlt": [{"subitem_language": "eng"}]}, "item_resource_type": {"attribute_name": "資源タイプ", "attribute_value_mlt": [{"resourcetype": "journal article", "resourceuri": "http://purl.org/coar/resource_type/c_6501"}]}, "item_title": "Clinical Efficacy on Fracture Risk and Safety of 0.5 mg or 1 mg/month Intravenous Ibandronate Versus 2.5 mg/day Oral Risedronate in Patients with Primary Osteoporosis", "item_titles": {"attribute_name": "タイトル", "attribute_value_mlt": [{"subitem_title": "Clinical Efficacy on Fracture Risk and Safety of 0.5 mg or 1 mg/month Intravenous Ibandronate Versus 2.5 mg/day Oral Risedronate in Patients with Primary Osteoporosis"}]}, "item_type_id": "2", "owner": "2", "path": ["9"], "permalink_uri": "http://hdl.handle.net/10069/33846", "pubdate": {"attribute_name": "公開日", "attribute_value": "2013-09-26"}, "publish_date": "2013-09-26", "publish_status": "0", "recid": "6829", "relation": {}, "relation_version_is_last": true, "title": ["Clinical Efficacy on Fracture Risk and Safety of 0.5 mg or 1 mg/month Intravenous Ibandronate Versus 2.5 mg/day Oral Risedronate in Patients with Primary Osteoporosis"], "weko_shared_id": -1}
Clinical Efficacy on Fracture Risk and Safety of 0.5 mg or 1 mg/month Intravenous Ibandronate Versus 2.5 mg/day Oral Risedronate in Patients with Primary Osteoporosis
http://hdl.handle.net/10069/33846
http://hdl.handle.net/10069/33846f4982aee-6f04-4bc0-b0a8-2789c9b001e1
名前 / ファイル | ライセンス | アクション |
---|---|---|
CTI93_137.pdf (587.5 kB)
|
|
Item type | 学術雑誌論文 / Journal Article(1) | |||||
---|---|---|---|---|---|---|
公開日 | 2013-09-26 | |||||
タイトル | ||||||
タイトル | Clinical Efficacy on Fracture Risk and Safety of 0.5 mg or 1 mg/month Intravenous Ibandronate Versus 2.5 mg/day Oral Risedronate in Patients with Primary Osteoporosis | |||||
言語 | ||||||
言語 | eng | |||||
キーワード | ||||||
主題Scheme | Other | |||||
主題 | Ibandronate | |||||
キーワード | ||||||
主題Scheme | Other | |||||
主題 | Intravenous | |||||
キーワード | ||||||
主題Scheme | Other | |||||
主題 | Osteoporosis | |||||
キーワード | ||||||
主題Scheme | Other | |||||
主題 | Risedronate | |||||
キーワード | ||||||
主題Scheme | Other | |||||
主題 | Vertebral fracture | |||||
資源タイプ | ||||||
資源タイプ識別子 | http://purl.org/coar/resource_type/c_6501 | |||||
資源タイプ | journal article | |||||
著者 |
Nakamura, Toshitaka
× Nakamura, Toshitaka× Nakano, Tetsuo× Ito, Masako× Hagino, Hiroshi× Hashimoto, Junko× Tobinai, Masato× Mizunuma, Hideki |
|||||
抄録 | ||||||
内容記述タイプ | Abstract | |||||
内容記述 | This randomized, double-blind study assessed the antifracture efficacy and safety of intermittent intravenous (IV) ibandronate versus oral daily risedronate in Japanese patients with primary osteoporosis. Ambulatory patients aged ≥60 years were randomized to receive 0.5 or 1 mg/month IV ibandronate plus oral daily placebo or 2.5 mg/day oral risedronate, the licensed dose in Japan, plus IV placebo. The primary end point was noninferiority of ibandronate versus risedronate for first new or worsening vertebral fracture over 3 years. A total of 1,265 patients were randomized. A total of 1,134 patients formed the per-protocol set. Both ibandronate doses were noninferior to risedronate: 0.5 mg, hazard ratio (HR) 1.09 [95 % confidence interval (CI) 0.77-1.54]; 1 mg, HR 0.88 (95 % CI 0.61-1.27). The rate of first new vertebral fracture over 3 years was 16.8 % (95 % CI 12.8-20.8) for 0.5 mg ibandronate, 11.6 % (95 % CI 8.2-15.0) for 1 mg ibandronate, and 13.2 % (95 % CI 9.6-16.9) for risedronate. Significant increases in bone mineral density relative to baseline were observed with all treatments after 6 months, with substantial reductions in bone turnover markers after 3 months. Greatest efficacy was obtained with 1 mg ibandronate. Analyses in women only showed similar results to the overall population. No new safety concerns were identified. This study demonstrated the noninferiority of IV ibandronate to the licensed Japanese dose of oral risedronate and suggested that 1 mg/month is an effective dose in Japanese patients with primary osteoporosis. | |||||
書誌情報 |
Calcified Tissue International 巻 93, 号 2, p. 137-146, 発行日 2013-08 |
|||||
出版者 | ||||||
出版者 | Springer New York | |||||
ISSN | ||||||
収録物識別子タイプ | ISSN | |||||
収録物識別子 | 0171967X | |||||
EISSN | ||||||
収録物識別子タイプ | ISSN | |||||
収録物識別子 | 14320827 | |||||
DOI | ||||||
関連タイプ | isIdenticalTo | |||||
識別子タイプ | DOI | |||||
関連識別子 | 10.1007/s00223-013-9734-6 | |||||
権利 | ||||||
権利情報 | © The Author(s) 2013. This article is published with open access at Springerlink.com | |||||
著者版フラグ | ||||||
出版タイプ | VoR | |||||
出版タイプResource | http://purl.org/coar/version/c_970fb48d4fbd8a85 | |||||
引用 | ||||||
内容記述タイプ | Other | |||||
内容記述 | Calcified Tissue International, 93(2), pp.137-146; 2013 |