Efficacy and tolerability of intravenous ibandronate injections in postmenopausal osteoporosis

2-Year results from the DIVA study

John A. Eisman, Roberto Civitelli, Silvano Adami, 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

119 Citations (Scopus)

Abstract

Objective. An effective and well tolerated intravenous (IV) bisphosphonate could provide a new treatment method for patients with osteoporosis. The Dosing Intra Venous 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 1 collagen were reduced to a similar extent in all treatment arms (53.4%-59.9%). The tolerability profile of the IV regimens was similar to that observed with daily oral therapy. Conclusion. Ibandronate 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
StatePublished - Mar 2008

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Postmenopausal Osteoporosis
Intravenous Injections
Bone Density
Spine
Bone Resorption
Femur
Osteoporosis
Placebos
Therapeutics
Diphosphonates
Menopause
Collagen Type I
Vitamin D
ibandronic acid
Appointments and Schedules
Biomarkers
Calcium
Bone and Bones
Injections
Serum

All Science Journal Classification (ASJC) codes

  • Rheumatology
  • Immunology

Cite this

Efficacy and tolerability of intravenous ibandronate injections in postmenopausal osteoporosis : 2-Year results from the DIVA study. / Eisman, John A.; Civitelli, Roberto; Adami, 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, Adami, S, Czerwinski, E, Recknor, C, Prince, R, Reginster, JY, 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 ; Adami, 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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title = "Efficacy and tolerability of intravenous ibandronate injections in postmenopausal osteoporosis: 2-Year results from the DIVA study",
abstract = "Objective. An effective and well tolerated intravenous (IV) bisphosphonate could provide a new treatment method for patients with osteoporosis. The Dosing Intra Venous 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 1 collagen were reduced to a similar extent in all treatment arms (53.4{\%}-59.9{\%}). The tolerability profile of the IV regimens was similar to that observed with daily oral therapy. Conclusion. Ibandronate 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 - Adami, 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.

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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 Intra Venous 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 1 collagen were reduced to a similar extent in all treatment arms (53.4%-59.9%). The tolerability profile of the IV regimens was similar to that observed with daily oral therapy. Conclusion. Ibandronate 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 Intra Venous 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 1 collagen were reduced to a similar extent in all treatment arms (53.4%-59.9%). The tolerability profile of the IV regimens was similar to that observed with daily oral therapy. Conclusion. Ibandronate IV injections are an effective and well tolerated treatment for postmenopausal osteoporosis and provide a useful alternative to oral dosing.

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