Ibandronate: An IV injection for the treatment for postmenopausal osteoporosis

Rene Rizzoli, David M. Reid

Research output: Contribution to journalArticle

5 Citations (Scopus)

Abstract

Intravenous (IV) bisphosphonate dosing for women with postmenopausal osteoporosis is an attractive treatment option where oral therapy is inappropriate because of tolerability or compliance issues. lbandronate, a potent nitrogen-containing bisphosphonate, can be administered by simple IV injection. The optimal dose and interval for this new regimen have been investigated in a detailed clinical trial program.

In a pilot study, ibandronate 0.25-2 mg IV every 3 months produced dose-dependent increases in lumbar spine bone mineral density (BMD) at 1 year that were superior to placebo in all but the 0.25 mg group (P <= 0.006). Dose-dependent decreases in urinary levels of C-telopeptide of the alpha-chain of type I collagen (CTX) were also reported. In a 3-year phase III, antifracture study, dose-dependent gains in BMD and reductions in bone markers with ibandronate 0.5 and 1 mg IV every 3 months were less pronounced than those previously reported for daily oral ibandronate (2.5 mg), and vertebral fracture risk was not significantly different to placebo. However, in a subsequent trial a higher quarterly dose (2 mg) produced greater improvements in BMD and bone turnover markers than both placebo and the 1 mg IV dose.

Direct comparison with daily oral ibandronate in the DIVA (Dosing Intravenous Administration) study showed that gains in lumbar spine BMD with both IV ibandronate doses (2 mg every 2 months and 3 mg every 3 months) were statistically superior to the oral dose (2.5 mg daily) after 1 year (P<0.001), with a similar result for total hip and trochanter BMD. Serum CTX concentration was markedly reduced in all groups after 1 year. The overall tolerability profile of IV ibandronate was similar to oral ibandronate, with no evidence of renal toxicity. Influenza-like illness was slightly more common with the IV (5.1% and 4.9% in the 2 mg and 3 mg groups, respectively) than the oral regimen (1.1%) but symptoms were tolerable and primarily associated with the first injection. lbandronate IV injection administered over 15-30 s can therefore provide superior efficacy to the daily oral regimen for which antifracture efficacy has been demonstrated (62% vertebral fracture risk reduction). Ibandronate is the only TV bisphosphonate licensed for the treatment of postmenopausal osteoporosis and can be conveniently administered at quarterly follow-up visits. (C) 2007 Elsevier Inc. All rights reserved.

Original languageEnglish
Pages (from-to)S24-S28
Number of pages5
JournalBone
Volume41
Issue number5 Suppl. 1
DOIs
Publication statusPublished - Nov 2007

Keywords

  • ibandronate
  • bisphosphonate
  • postmenopausal osteoporosis
  • fracture
  • bone mineral density
  • antifracture efficacy
  • nonvertebral fractures
  • antiresorptive agents
  • vertebral fractures
  • randomized trial
  • zoledronic acid
  • elderly-women
  • renal-failure
  • hip fracture
  • bone-density

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