Efficacy and tolerability of intravenous ibandronate injections in postmenopausal osteoporosis

2-year results from the DIVA study

John A. Eisman, Roberto Civitelli, Silvano Adaml, Edward Czerwinski, Chris Recknor, Richard Prince, Jean-Yves Reginster, Mone Zaidi, Dieter Felsenberg, Claire Hughes, Nicole Mairon, Daiva Masanauskaite, David M. Reid, Pierre D. Delmas, Robert R. Recker

Research output: Contribution to journalArticle

121 Citations (Scopus)

Abstract

Objective: An effective and well tolerated intravenous (IV) bisphosphonate could provide a new treatment method for patients with osteoporosis. The Dosing IntraVenous Administration (DIVA) study was designed to identify the optimal ibandronate IV injection schedule for the treatment of postmenopausal osteoporosis by comparing the efficacy and tolerability of 2- and 3-monthly injections with the previously evaluated daily oral ibandronate regimen. We report the effects on lumbar spine and proximal femur bone mineral density (BMD) and bone resorption markers over 2 years.

Methods: This randomized, double-blind, double-dummy, noninferiority study recruited 1395 women (aged 55-80 yrs; >= 5 yrs since menopause) with osteoporosis [mean lumbar spine (L2-L4) BMD T-score < -2.5 and >= -5.0]. Patients received IV ibandronate (2 mg every 2 mo or 3 mg every 3 mo) plus daily oral placebo, or 2.5 mg daily oral ibandronate plus 2- or 3-monthly IV placebo. Supplemental vitamin D (400 IU) and calcium (500 mg) were provided throughout the 2-year study.

Results: At 2 years, the 2- and 3-monthly IV regimens achieved statistically noninferior and also superior increases in lumbar spine BMD compared with the daily regimen (6.4% and 6.3% vs 4.8%, respectively; p < 0.001). Greater increases were also obtained with IV ibandronate versus daily in proximal femur BMD. Serum concentrations of the biochemical marker of bone resorption C-telopeptide of the alpha-chain of type I collagen were reduced to a similar extent in all treatment anus (53.4%-59.9%). The tolerability profile of the IV regimens was similar to that observed with daily oral therapy.

Conclusion: lbandronate IV injections are an effective and well tolerated treatment for postmenopausal osteoporosis and provide a useful alternative to oral dosing.

Original languageEnglish
Pages (from-to)488-497
Number of pages10
JournalJournal of Rheumatology
Volume35
Issue number3
Early online date1 Feb 2008
Publication statusPublished - Mar 2008

Keywords

  • postmenopausal osteoporosis
  • ibandronate
  • intravenous
  • bisphosphonate
  • vertebral fracture risk
  • nonvertebral fractures
  • antiresorptive agents
  • antifracture efficacy
  • randomized-trial
  • zoledronic acid
  • bone-density
  • women
  • risedronate

Cite this

Eisman, J. A., Civitelli, R., Adaml, S., Czerwinski, E., Recknor, C., Prince, R., ... Recker, R. R. (2008). Efficacy and tolerability of intravenous ibandronate injections in postmenopausal osteoporosis: 2-year results from the DIVA study. Journal of Rheumatology, 35(3), 488-497.

Efficacy and tolerability of intravenous ibandronate injections in postmenopausal osteoporosis : 2-year results from the DIVA study. / Eisman, John A.; Civitelli, Roberto; Adaml, Silvano; Czerwinski, Edward; Recknor, Chris; Prince, Richard; Reginster, Jean-Yves; Zaidi, Mone; Felsenberg, Dieter; Hughes, Claire; Mairon, Nicole; Masanauskaite, Daiva; Reid, David M.; Delmas, Pierre D.; Recker, Robert R.

In: Journal of Rheumatology, Vol. 35, No. 3, 03.2008, p. 488-497.

Research output: Contribution to journalArticle

Eisman, JA, Civitelli, R, Adaml, S, Czerwinski, E, Recknor, C, Prince, R, Reginster, J-Y, Zaidi, M, Felsenberg, D, Hughes, C, Mairon, N, Masanauskaite, D, Reid, DM, Delmas, PD & Recker, RR 2008, 'Efficacy and tolerability of intravenous ibandronate injections in postmenopausal osteoporosis: 2-year results from the DIVA study', Journal of Rheumatology, vol. 35, no. 3, pp. 488-497.
Eisman, John A. ; Civitelli, Roberto ; Adaml, Silvano ; Czerwinski, Edward ; Recknor, Chris ; Prince, Richard ; Reginster, Jean-Yves ; Zaidi, Mone ; Felsenberg, Dieter ; Hughes, Claire ; Mairon, Nicole ; Masanauskaite, Daiva ; Reid, David M. ; Delmas, Pierre D. ; Recker, Robert R. / Efficacy and tolerability of intravenous ibandronate injections in postmenopausal osteoporosis : 2-year results from the DIVA study. In: Journal of Rheumatology. 2008 ; Vol. 35, No. 3. pp. 488-497.
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abstract = "Objective: An effective and well tolerated intravenous (IV) bisphosphonate could provide a new treatment method for patients with osteoporosis. The Dosing IntraVenous Administration (DIVA) study was designed to identify the optimal ibandronate IV injection schedule for the treatment of postmenopausal osteoporosis by comparing the efficacy and tolerability of 2- and 3-monthly injections with the previously evaluated daily oral ibandronate regimen. We report the effects on lumbar spine and proximal femur bone mineral density (BMD) and bone resorption markers over 2 years. Methods: This randomized, double-blind, double-dummy, noninferiority study recruited 1395 women (aged 55-80 yrs; >= 5 yrs since menopause) with osteoporosis [mean lumbar spine (L2-L4) BMD T-score < -2.5 and >= -5.0]. Patients received IV ibandronate (2 mg every 2 mo or 3 mg every 3 mo) plus daily oral placebo, or 2.5 mg daily oral ibandronate plus 2- or 3-monthly IV placebo. Supplemental vitamin D (400 IU) and calcium (500 mg) were provided throughout the 2-year study. Results: At 2 years, the 2- and 3-monthly IV regimens achieved statistically noninferior and also superior increases in lumbar spine BMD compared with the daily regimen (6.4{\%} and 6.3{\%} vs 4.8{\%}, respectively; p < 0.001). Greater increases were also obtained with IV ibandronate versus daily in proximal femur BMD. Serum concentrations of the biochemical marker of bone resorption C-telopeptide of the alpha-chain of type I collagen were reduced to a similar extent in all treatment anus (53.4{\%}-59.9{\%}). The tolerability profile of the IV regimens was similar to that observed with daily oral therapy. Conclusion: lbandronate IV injections are an effective and well tolerated treatment for postmenopausal osteoporosis and provide a useful alternative to oral dosing.",
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T1 - Efficacy and tolerability of intravenous ibandronate injections in postmenopausal osteoporosis

T2 - 2-year results from the DIVA study

AU - Eisman, John A.

AU - Civitelli, Roberto

AU - Adaml, Silvano

AU - Czerwinski, Edward

AU - Recknor, Chris

AU - Prince, Richard

AU - Reginster, Jean-Yves

AU - Zaidi, Mone

AU - Felsenberg, Dieter

AU - Hughes, Claire

AU - Mairon, Nicole

AU - Masanauskaite, Daiva

AU - Reid, David M.

AU - Delmas, Pierre D.

AU - Recker, Robert R.

PY - 2008/3

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N2 - Objective: An effective and well tolerated intravenous (IV) bisphosphonate could provide a new treatment method for patients with osteoporosis. The Dosing IntraVenous Administration (DIVA) study was designed to identify the optimal ibandronate IV injection schedule for the treatment of postmenopausal osteoporosis by comparing the efficacy and tolerability of 2- and 3-monthly injections with the previously evaluated daily oral ibandronate regimen. We report the effects on lumbar spine and proximal femur bone mineral density (BMD) and bone resorption markers over 2 years. Methods: This randomized, double-blind, double-dummy, noninferiority study recruited 1395 women (aged 55-80 yrs; >= 5 yrs since menopause) with osteoporosis [mean lumbar spine (L2-L4) BMD T-score < -2.5 and >= -5.0]. Patients received IV ibandronate (2 mg every 2 mo or 3 mg every 3 mo) plus daily oral placebo, or 2.5 mg daily oral ibandronate plus 2- or 3-monthly IV placebo. Supplemental vitamin D (400 IU) and calcium (500 mg) were provided throughout the 2-year study. Results: At 2 years, the 2- and 3-monthly IV regimens achieved statistically noninferior and also superior increases in lumbar spine BMD compared with the daily regimen (6.4% and 6.3% vs 4.8%, respectively; p < 0.001). Greater increases were also obtained with IV ibandronate versus daily in proximal femur BMD. Serum concentrations of the biochemical marker of bone resorption C-telopeptide of the alpha-chain of type I collagen were reduced to a similar extent in all treatment anus (53.4%-59.9%). The tolerability profile of the IV regimens was similar to that observed with daily oral therapy. Conclusion: lbandronate IV injections are an effective and well tolerated treatment for postmenopausal osteoporosis and provide a useful alternative to oral dosing.

AB - Objective: An effective and well tolerated intravenous (IV) bisphosphonate could provide a new treatment method for patients with osteoporosis. The Dosing IntraVenous Administration (DIVA) study was designed to identify the optimal ibandronate IV injection schedule for the treatment of postmenopausal osteoporosis by comparing the efficacy and tolerability of 2- and 3-monthly injections with the previously evaluated daily oral ibandronate regimen. We report the effects on lumbar spine and proximal femur bone mineral density (BMD) and bone resorption markers over 2 years. Methods: This randomized, double-blind, double-dummy, noninferiority study recruited 1395 women (aged 55-80 yrs; >= 5 yrs since menopause) with osteoporosis [mean lumbar spine (L2-L4) BMD T-score < -2.5 and >= -5.0]. Patients received IV ibandronate (2 mg every 2 mo or 3 mg every 3 mo) plus daily oral placebo, or 2.5 mg daily oral ibandronate plus 2- or 3-monthly IV placebo. Supplemental vitamin D (400 IU) and calcium (500 mg) were provided throughout the 2-year study. Results: At 2 years, the 2- and 3-monthly IV regimens achieved statistically noninferior and also superior increases in lumbar spine BMD compared with the daily regimen (6.4% and 6.3% vs 4.8%, respectively; p < 0.001). Greater increases were also obtained with IV ibandronate versus daily in proximal femur BMD. Serum concentrations of the biochemical marker of bone resorption C-telopeptide of the alpha-chain of type I collagen were reduced to a similar extent in all treatment anus (53.4%-59.9%). The tolerability profile of the IV regimens was similar to that observed with daily oral therapy. Conclusion: lbandronate IV injections are an effective and well tolerated treatment for postmenopausal osteoporosis and provide a useful alternative to oral dosing.

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KW - bisphosphonate

KW - vertebral fracture risk

KW - nonvertebral fractures

KW - antiresorptive agents

KW - antifracture efficacy

KW - randomized-trial

KW - zoledronic acid

KW - bone-density

KW - women

KW - risedronate

M3 - Article

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EP - 497

JO - Journal of Rheumatology

JF - Journal of Rheumatology

SN - 0315-162X

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