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Bisphosphonates in the management of postmenopausal osteoporosis--optimizing efficacy in clinical practice.

Bock O, Felsenberg D - Clin Interv Aging (2008)

Bottom Line: However, treatment effects in an individual patient and cost-effectiveness in public health perspective are vitally dependent on the long-term patient adherence as well as on compliance and persistence.Treatment acceptance could be further improved by IV bisphosphonates with their benefit of only quarterly, or even once-yearly, application.In addition, to ensure best possible patient adherence and maximum treatment benefits, physicians should consider individual patient conditions affecting compliance and persistence as well as patient preferences.

View Article: PubMed Central - PubMed

Affiliation: Center for Muscle and Bone Research, Campus Benjamin Franklin, Charité - University Medicine Berlin, Berlin, Germany. oliver.bock@charite.de

ABSTRACT
Nitrogen-containing bisphosphonates are potent inhibitors of osteoclastic bone resorption. With their individually proven efficacy to significantly reduce the incidence of vertebral and/or non-vertebral fractures and with their overall beneficial safety profile, alendronate, ibandronate, risedronate, and zoledronate are considered today a treatment of first choice in postmenopausal osteoporosis. However, treatment effects in an individual patient and cost-effectiveness in public health perspective are vitally dependent on the long-term patient adherence as well as on compliance and persistence. As compliance and persistence with daily oral bisphosphonates are shown to be suboptimal in many patients, leading to an increased fracture incidence in non-compliant patients, there is a need to improve overall adherence for bisphosphonate treatment in order to achieve maximum treatment effects. One option is to extend dosing intervals to weekly (alendronate, risedronate) or monthly (ibandronate) oral regimens. Less frequent oral regimens are generally preferred by majority of patients. Another alternative is intravenous, instead of oral application (ibandronate, zoledronate). Treatment acceptance could be further improved by IV bisphosphonates with their benefit of only quarterly, or even once-yearly, application. Treatment decisions should be based on anti-fracture efficacy data first. In addition, to ensure best possible patient adherence and maximum treatment benefits, physicians should consider individual patient conditions affecting compliance and persistence as well as patient preferences.

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Related in: MedlinePlus

Mortality as a secondary endpoint in the HORIZON-RFT (Recurrent Fracture Trial) with zoledronate: in the safety analysis, a total of 242 of 2111 patients (11.5%) died during the study, 101 of 1054 (9.6%) were in the zoledronate group and 141 of 1057 (13.3%) were in the placebo group (hazard ratio for the zoledronate group, 0.72; 95% CI, 0.56–0.93; p = 0.01). Adapted with permission from Lyles KW, Colón-Emeric CS, Magaziner JS, et al. 2007. Zoledronic acid and clinical fractures and mortality after hip fracture. N Engl J Med, 357:1799–809. Copyright © 2007 Massachusetts Medical Society. All rights reserved.
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fig2: Mortality as a secondary endpoint in the HORIZON-RFT (Recurrent Fracture Trial) with zoledronate: in the safety analysis, a total of 242 of 2111 patients (11.5%) died during the study, 101 of 1054 (9.6%) were in the zoledronate group and 141 of 1057 (13.3%) were in the placebo group (hazard ratio for the zoledronate group, 0.72; 95% CI, 0.56–0.93; p = 0.01). Adapted with permission from Lyles KW, Colón-Emeric CS, Magaziner JS, et al. 2007. Zoledronic acid and clinical fractures and mortality after hip fracture. N Engl J Med, 357:1799–809. Copyright © 2007 Massachusetts Medical Society. All rights reserved.

Mentions: The only study so far demonstrating improved survival in treated osteoporosis patients is the HORIZON-RFT with zoledronate (Lyles et al 2007). In this randomized, double-blind, placebo-controlled trial in men and women after hip fracture, 1065 patients were assigned to receive yearly intravenous zoledronate (at a dose of 5 mg), and 1062 patients were assigned to receive placebo. The infusions were first administered within 90 days after surgery for a hip fracture. In this event-driven study (new clinical fractures), the median follow-up was 1.9 years. The rates of any new clinical fracture were 8.6% in the zoledronate group and 13.9% in the placebo group, a 35% risk reduction with zoledronate (p = 0.001); the respective rates of a new clinical vertebral fracture were 1.7% and 3.8% (p = 0.02), and the respective rates of new non-vertebral fractures were 7.6% and 10.7% (p = 0.03). In the safety analysis, 101 of 1054 patients in the zoledronate group (9.6%) and 141 of 1057 patients in the placebo group (13.3%) died, a reduction of 28% in deaths from any cause in the zoledronate group (p = 0.01) (see Figure 2).


Bisphosphonates in the management of postmenopausal osteoporosis--optimizing efficacy in clinical practice.

Bock O, Felsenberg D - Clin Interv Aging (2008)

Mortality as a secondary endpoint in the HORIZON-RFT (Recurrent Fracture Trial) with zoledronate: in the safety analysis, a total of 242 of 2111 patients (11.5%) died during the study, 101 of 1054 (9.6%) were in the zoledronate group and 141 of 1057 (13.3%) were in the placebo group (hazard ratio for the zoledronate group, 0.72; 95% CI, 0.56–0.93; p = 0.01). Adapted with permission from Lyles KW, Colón-Emeric CS, Magaziner JS, et al. 2007. Zoledronic acid and clinical fractures and mortality after hip fracture. N Engl J Med, 357:1799–809. Copyright © 2007 Massachusetts Medical Society. All rights reserved.
© Copyright Policy
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC2546473&req=5

fig2: Mortality as a secondary endpoint in the HORIZON-RFT (Recurrent Fracture Trial) with zoledronate: in the safety analysis, a total of 242 of 2111 patients (11.5%) died during the study, 101 of 1054 (9.6%) were in the zoledronate group and 141 of 1057 (13.3%) were in the placebo group (hazard ratio for the zoledronate group, 0.72; 95% CI, 0.56–0.93; p = 0.01). Adapted with permission from Lyles KW, Colón-Emeric CS, Magaziner JS, et al. 2007. Zoledronic acid and clinical fractures and mortality after hip fracture. N Engl J Med, 357:1799–809. Copyright © 2007 Massachusetts Medical Society. All rights reserved.
Mentions: The only study so far demonstrating improved survival in treated osteoporosis patients is the HORIZON-RFT with zoledronate (Lyles et al 2007). In this randomized, double-blind, placebo-controlled trial in men and women after hip fracture, 1065 patients were assigned to receive yearly intravenous zoledronate (at a dose of 5 mg), and 1062 patients were assigned to receive placebo. The infusions were first administered within 90 days after surgery for a hip fracture. In this event-driven study (new clinical fractures), the median follow-up was 1.9 years. The rates of any new clinical fracture were 8.6% in the zoledronate group and 13.9% in the placebo group, a 35% risk reduction with zoledronate (p = 0.001); the respective rates of a new clinical vertebral fracture were 1.7% and 3.8% (p = 0.02), and the respective rates of new non-vertebral fractures were 7.6% and 10.7% (p = 0.03). In the safety analysis, 101 of 1054 patients in the zoledronate group (9.6%) and 141 of 1057 patients in the placebo group (13.3%) died, a reduction of 28% in deaths from any cause in the zoledronate group (p = 0.01) (see Figure 2).

Bottom Line: However, treatment effects in an individual patient and cost-effectiveness in public health perspective are vitally dependent on the long-term patient adherence as well as on compliance and persistence.Treatment acceptance could be further improved by IV bisphosphonates with their benefit of only quarterly, or even once-yearly, application.In addition, to ensure best possible patient adherence and maximum treatment benefits, physicians should consider individual patient conditions affecting compliance and persistence as well as patient preferences.

View Article: PubMed Central - PubMed

Affiliation: Center for Muscle and Bone Research, Campus Benjamin Franklin, Charité - University Medicine Berlin, Berlin, Germany. oliver.bock@charite.de

ABSTRACT
Nitrogen-containing bisphosphonates are potent inhibitors of osteoclastic bone resorption. With their individually proven efficacy to significantly reduce the incidence of vertebral and/or non-vertebral fractures and with their overall beneficial safety profile, alendronate, ibandronate, risedronate, and zoledronate are considered today a treatment of first choice in postmenopausal osteoporosis. However, treatment effects in an individual patient and cost-effectiveness in public health perspective are vitally dependent on the long-term patient adherence as well as on compliance and persistence. As compliance and persistence with daily oral bisphosphonates are shown to be suboptimal in many patients, leading to an increased fracture incidence in non-compliant patients, there is a need to improve overall adherence for bisphosphonate treatment in order to achieve maximum treatment effects. One option is to extend dosing intervals to weekly (alendronate, risedronate) or monthly (ibandronate) oral regimens. Less frequent oral regimens are generally preferred by majority of patients. Another alternative is intravenous, instead of oral application (ibandronate, zoledronate). Treatment acceptance could be further improved by IV bisphosphonates with their benefit of only quarterly, or even once-yearly, application. Treatment decisions should be based on anti-fracture efficacy data first. In addition, to ensure best possible patient adherence and maximum treatment benefits, physicians should consider individual patient conditions affecting compliance and persistence as well as patient preferences.

Show MeSH
Related in: MedlinePlus