gms | German Medical Science

Deutscher Kongress für Orthopädie und Unfallchirurgie
70. Jahrestagung der Deutschen Gesellschaft für Unfallchirurgie
92. Tagung der Deutschen Gesellschaft für Orthopädie und Orthopädische Chirurgie und
47. Tagung des Berufsverbandes der Fachärzte für Orthopädie

02. - 06.10.2006, Berlin

Intermittent intravenous ibandronate injections are effective and well tolerated over 2 years of treatment in postmenopausal osteoporosis

Meeting Abstract

Suche in Medline nach

  • D. Felsenberg - Osteoporose Forschungsgruppe, Charité-University Medicine Berlin, Berlin, Germany
  • J. Pfeilschifter - Medizinische Klinik I, Evangelisches Krankenhaus Lutherhaus, Essen, Germany
  • H.-P. Kruse - Abt. fur Nephrologie und Osteologie, Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany

Deutscher Kongress für Orthopädie und Unfallchirurgie. 70. Jahrestagung der Deutschen Gesellschaft für Unfallchirurgie, 92. Tagung der Deutschen Gesellschaft für Orthopädie und Orthopädische Chirurgie und 47. Tagung des Berufsverbandes der Fachärzte für Orthopädie. Berlin, 02.-06.10.2006. Düsseldorf, Köln: German Medical Science; 2006. DocW.15.2-1232

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Veröffentlicht: 28. September 2006

© 2006 Felsenberg et al.
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Introduction: Oral bisphosphonates are the current mainstay of treatment for postmenopausal osteoporosis, but are not appropriate for all patients. An effective and well tolerated intravenous (i.v.) bisphosphonate could be an attractive treatment option when oral bisphosphonates are contraindicated or otherwise unsuitable. Ibandronate is a potent, nitrogen-containing bisphosphonate that, in addition to its once-monthly oral formulation, can be administered as a rapid (15–30 second) i.v. injection. One-year results from the DIVA study showed that 2- or 3-monthly i.v. ibandronate injections were associated with greater improvements in spinal bone mineral density (BMD) than an established daily oral regimen with proven antifracture efficacy. We now present 2-year efficacy and safety data from DIVA.

Methods: DIVA was a randomized, double-blind, double-dummy, non-inferiority trial, into which 1,395 women aged 55–80 years (≥5 years after menopause) were enrolled. All patients were diagnosed with osteoporosis, as defined by a lumbar spine (L2–L4) BMD T-score of less than –2.5. Study participants were randomized to receive either i.v. (2mg every 2 months [q2mo] or 3mg every 3 months [q3mo]) or oral (2.5mg daily) ibandronate therapy. To ensure blinding, patients received an oral or i.v. placebo as appropriate, and all patients received supplementation with vitamin D (400IU/day) and calcium (500mg/day). Efficacy assessments included BMD at the lumbar spine and hip and serum CTX levels. Adverse events (AEs) were monitored throughout the study.

Results: After 2 years of treatment, improvements in lumbar spine BMD were observed in all treatment groups: 6.4% in the q2mo arm, 6.3% in the q3mo arm and 4.8% in the daily arm. Improvements in the i.v. arms were statistically non-inferior (margin: 1.3%) and also superior (p<0.001) when compared with the oral arm. Significantly greater improvements in total hip and hip trochanter BMD (p<0.001) were also seen with the i.v. regimens. Serum CTX levels were reduced by clinically meaningful margins (53.4–59.9%) in all three treatment groups. The overall incidence of AEs was similar in the three groups (85–89%), with a slightly higher incidence of drug-related AEs in the i.v. ibandronate groups, although these were generally related to symptoms commonly associated with i.v. bisphosphonate administration (e.g. flu-like illness and transient, musculoskeletal symptoms). Study withdrawals were similar across the three treatment groups (10–12%).

Conclusions: I.v. injections of ibandronate produced greater increases in BMD than an established daily oral ibandronate regimen in postmenopausal women with osteoporosis. All treatment regimens were well tolerated. Intermittent i.v. injections may be an important treatment option for patients in whom oral bisphosphonates are not suitable.