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Higher response with bone mineral density increase with monthly injectable ibandronate 1 mg compared with oral risedronate in the MOVER study.
Nakano, Tetsuo; Yamamoto, Masao; Hashimoto, Junko; Tobinai, Masato; Yoshida, Seitaro; Nakamura, Toshitaka.
Afiliação
  • Nakano T; Tamana Central Hospital, Kumamoto, Japan.
  • Yamamoto M; Project & Lifecycle Management Unit, Chugai Pharmaceutical Co. Ltd., Tokyo, Japan.
  • Hashimoto J; Project & Lifecycle Management Unit, Chugai Pharmaceutical Co. Ltd., Tokyo, Japan. hashimotojnk@chugai-pharm.co.jp.
  • Tobinai M; Clinical Development Division, Chugai Pharmaceutical Co. Ltd., Tokyo, Japan.
  • Yoshida S; Clinical Development Division, Chugai Pharmaceutical Co. Ltd., Tokyo, Japan.
  • Nakamura T; National Center for Global Health and Medicine, Tokyo, Japan.
J Bone Miner Metab ; 34(6): 678-684, 2016 Nov.
Article em En | MEDLINE | ID: mdl-26462480
ABSTRACT
We examined response to bone mineral density (BMD) gains in the MOVER study following treatment with intravenous (IV) ibandronate 1 mg/month, and investigated the characteristics of a non-responder group. At 1 year, responder rates for patients with BMD increases >0 % were similar with IV ibandronate 0.5 or 1 mg/month and oral risedronate 2.5 mg/day. However, after 3 years, responder rates with BMD increases ≥3 % were highest with ibandronate 1 mg at all bone sites (>80 % at the lumbar spine [L2-L4] and >50 % at all femur sites, which was significantly higher than with risedronate). Non-responders were defined by BMD increases ≤3 % at L2-L4 or ≤0 % at total hip, and ≤50 % reduction in creatinine-corrected urinary collagen type 1 cross-linked C-telopeptide (uCTX) from baseline to 1 year. There were a small number of non-responders in the ibandronate 1 mg group 3.3 % (10/299) with ≤0 % total hip BMD increase and ≤50 % uCTX reduction from baseline. These non-responders had lower 25-hydroxyvitamin D (25[OH]D) levels than responders, but no differences in kidney function, L2-L4 BMD or bone turnover marker baseline values. Throughout the study, non-responders failed to show any increases in BMD. Our analysis demonstrates significantly higher responder rates with IV ibandronate 1 mg/month than with risedronate at 3 years. A small number of non-responders in the ibandronate group had lower 25(OH)D baseline levels than responders, suggesting that 25(OH)D levels could be a useful indicator of BMD response to therapy.
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Base de dados: MEDLINE Assunto principal: Osteoporose / Densidade Óssea / Difosfonatos / Ácido Risedrônico / Vértebras Lombares Tipo de estudo: Clinical_trials / Etiology_studies Limite: Aged / Female / Humans / Male / Middle aged Idioma: En Revista: J Bone Miner Metab Assunto da revista: METABOLISMO Ano de publicação: 2016 Tipo de documento: Article País de afiliação: Japão
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Base de dados: MEDLINE Assunto principal: Osteoporose / Densidade Óssea / Difosfonatos / Ácido Risedrônico / Vértebras Lombares Tipo de estudo: Clinical_trials / Etiology_studies Limite: Aged / Female / Humans / Male / Middle aged Idioma: En Revista: J Bone Miner Metab Assunto da revista: METABOLISMO Ano de publicação: 2016 Tipo de documento: Article País de afiliação: Japão