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

Cite this

Ibandronate: An IV injection for the treatment for postmenopausal osteoporosis. / Rizzoli, Rene; Reid, David M.

In: Bone, Vol. 41, No. 5 Suppl. 1, 11.2007, p. S24-S28.

Research output: Contribution to journalArticle

Rizzoli, Rene ; Reid, David M. / Ibandronate: An IV injection for the treatment for postmenopausal osteoporosis. In: Bone. 2007 ; Vol. 41, No. 5 Suppl. 1. pp. S24-S28.
@article{900aaf0793794e7a813912091262c8a6,
title = "Ibandronate: An IV injection for the treatment for postmenopausal osteoporosis",
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.",
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",
author = "Rene Rizzoli and Reid, {David M.}",
year = "2007",
month = "11",
doi = "10.1016/j.bone.2007.08.006",
language = "English",
volume = "41",
pages = "S24--S28",
journal = "Bone",
issn = "8756-3282",
publisher = "Elsevier Inc.",
number = "5 Suppl. 1",

}

TY - JOUR

T1 - Ibandronate: An IV injection for the treatment for postmenopausal osteoporosis

AU - Rizzoli, Rene

AU - Reid, David M.

PY - 2007/11

Y1 - 2007/11

N2 - 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.

AB - 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.

KW - ibandronate

KW - bisphosphonate

KW - postmenopausal osteoporosis

KW - fracture

KW - bone mineral density

KW - antifracture efficacy

KW - nonvertebral fractures

KW - antiresorptive agents

KW - vertebral fractures

KW - randomized trial

KW - zoledronic acid

KW - elderly-women

KW - renal-failure

KW - hip fracture

KW - bone-density

U2 - 10.1016/j.bone.2007.08.006

DO - 10.1016/j.bone.2007.08.006

M3 - Article

VL - 41

SP - S24-S28

JO - Bone

JF - Bone

SN - 8756-3282

IS - 5 Suppl. 1

ER -