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Steven Boonen - One of the best experts on this subject based on the ideXlab platform.
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fracture risk and Zoledronic Acid therapy in men with osteoporosis
The New England Journal of Medicine, 2012Co-Authors: Steven Boonen, Jeanyves Reginster, Jeanmarc Kaufman, Kurt Lippuner, J R Zanchetta, Bente L Langdahl, Rene Rizzoli, Stanley Lipschitz, Hans Peter Dimai, Richard WitvrouwAbstract:Background Fractures in men are a major health issue, and data on the antifracture efficacy of therapies for osteoporosis in men are limited. We studied the effect of Zoledronic Acid on fracture risk among men with osteoporosis. Methods In this multicenter, double-blind, placebo-controlled trial, we randomly assigned 1199 men with primary or hypogonadism-associated osteoporosis who were 50 to 85 years of age to receive an intravenous infusion of Zoledronic Acid (5 mg) or placebo at baseline and at 12 months. Participants received daily calcium and vitamin D supplementation. The primary end point was the proportion of participants with one or more new morphometric vertebral fractures over a period of 24 months. Results The rate of any new morphometric vertebral fracture was 1.6% in the Zoledronic Acid group and 4.9% in the placebo group over the 24-month period, representing a 67% risk reduction with Zoledronic Acid (relative risk, 0.33; 95% confidence interval, 0.16 to 0.70; P=0.002). As compared with men...
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Potential mediators of the mortality reduction with Zoledronic Acid after hip fracture
Journal of Bone and Mineral Research, 2009Co-Authors: Cathleen S. Colón-emeric, Pierre D Delmas, Steven Boonen, Kenneth W Lyles, Carl F Pieper, Peter Mesenbrink, Erik Fink Eriksen, Jay MagazinerAbstract:Zoledronic Acid reduces the risk of death by 28% after hip fracture, but the mechanisms are not known. This exploratory analysis sought to identify potential pathways for the reduction in mortality with Zoledronic Acid after hip fracture. This was a retrospective analysis of a randomized, controlled trial. Patients with recent hip fracture (n = 2111) were treated with Zoledronic Acid or placebo infusion yearly, as well as calcium and vitamin D supplementation. Causes of death were adjudicated by a blinded central review committee. Baseline comorbidities, events occurring during the study period, including subsequent fracture, change in bone density, infections, cardiovascular events, arrhythmias, and falls, were included in multivariable analyses. In a model adjusted for baseline risk factors, Zoledronic Acid reduced the risk of death by 25% [95% confidence interval (CI) 0.58-0.97). The effect was consistent across most subgroups. Subsequent fractures were significantly associated with death (hazard ratio 1.72, 95% CI 1.17-2.51) but explained only 8% of the Zoledronic Acid effect. Adjusting for acute events occurring during follow-up eliminated the death benefit, and Zoledronic Acid-treated subjects were less likely to die from pneumonia (interaction p = .04) and arrhythmias (interaction p = .02) than placebo-treated subjects. Only 8% of Zoledronic Acid's death benefit is due to a reduction in secondary fractures. Zoledronic Acid may have an effect on cardiovascular events and pneumonia. Further studies of Zoledronic Acid in other acute illnesses may be warranted.
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effects of intravenous Zoledronic Acid once yearly on bone remodeling and bone structure
Journal of Bone and Mineral Research, 2007Co-Authors: Robert R Recker, Pierre D Delmas, Ian R Reid, Steven Boonen, Johan Halse, Pedro A Garciahernandez, Jerzy Supronik, Michael E Lewiecki, Luis Ochoa, Paul D MillerAbstract:In a substudy of the HORIZON pivotal fracture trial, in which yearly intravenous Zoledronic Acid 5 mg was found to significantly reduce risk of various fracture types in patients with postmenopausal osteoporosis, 152 patients underwent bone biopsy. Zoledronic Acid reduced bone turnover by 63% and preserved bone structure and volume, with evidence of ongoing bone remodeling in 99% of biopsies obtained. Introduction: In the HORIZON pivotal fracture trial (PFT), enrolling 7736 women with postmenopausal osteoporosis, three annual intravenous infusions of the bisphosphonate Zoledronic Acid (5 mg) significantly reduced morphometric vertebral, clinical vertebral, hip, and nonvertebral fractures by 70%, 77%, 41%, and 25%, respectively. Whereas 79% of patients received Zoledronic Acid/placebo only (stratum I, n = 6113), 21% received concomitant treatment with other antiresorptive drugs, excluding other bisphosphonates, PTH, and strontium (stratum II, n = 1652). Materials and Methods: To determine effects on bone remodeling and bone architecture, iliac crest bone biopsies were obtained in 152 patients on active treatment or placebo at 3 yr after double tetracycline labeling. In five patients, only qualitative histology was performed, leaving 147 biopsy cores (79 on active treatment and 68 on placebo) for νCT analysis and histomorphometry. Results: Analysis of bone structure by νCT revealed higher trabecular bone volume (BV/TV) in the Zoledronic Acid group (median, 16.6% versus 12.8%; p = 0.020). In addition, patients treated with Zoledronic Acid exhibited higher trabecular numbers (p = 0.008), decreased trabecular separation (p = 0.011), and a trend toward improvement in connectivity density (p = 0.062), all indicating better preservation of trabecular structure after treatment with Zoledronic Acid. Qualitative analysis revealed presence of tetracycline label in 81 of 82 biopsies from patients on Zoledronic Acid and all 70 biopsies from placebo patients, indicative of continued bone remodeling. No bone pathology was observed. Zoledronic Acid induced a 63% median (71% mean) reduction of the activation frequency (Ac.f; p < 0.0001) and reduced mineralizing surface (MS/BS; p < 0.0001) and volume referent bone formation rate (BFR/BV) versus placebo, indicating reduced bone turnover. Mineral appositional rate was higher in the Zoledronic Acid group (p = 0.0002), suggesting improved osteoblast function compared with placebo. Mineralization lag time was similar in the two groups, whereas osteoid volume (OV/BV; p < 0.0001) and osteoid thickness (O. Th; p = 0.0094) were lower in Zoledronic Acid-treated patients, indicating normal osteoid formation and mineralization of newly formed bone. Concomitant administration of other antiresorptive osteoporosis therapies (e.g., raloxifene, tamoxifen, tibolone, ipriflavone) did not significantly alter the tissue level response to Zoledronic Acid. Conclusions: Annual dosing for 3 yr with Zoledronic Acid 5 mg intravenously resulted in a median 63% (mean, 71%) reduction of bone turnover and preservation of bone structure and mass without any signs of adynamic bone. Concomitant treatment with other osteoporosis therapies did not significantly affect the bone response to Zoledronic Acid.
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once yearly Zoledronic Acid for treatment of postmenopausal osteoporosis
The New England Journal of Medicine, 2007Co-Authors: Dennis M Black, Pierre D Delmas, R Eastell, Ian R Reid, Steven Boonen, Jane A Cauley, Felicia Cosman, Peter L Lakatos, Ping Chung Leung, C MautalenAbstract:Background A single infusion of intravenous Zoledronic Acid decreases bone turnover and improves bone density at 12 months in postmenopausal women with osteoporosis. We assessed the effects of annual infusions of Zoledronic Acid on fracture risk during a 3-year period. Methods In this double-blind, placebo-controlled trial, 3889 patients (mean age, 73 years) were randomly assigned to receive a single 15-minute infusion of Zoledronic Acid (5 mg) and 3876 were assigned to receive placebo at baseline, at 12 months, and at 24 months; the patients were followed until 36 months. Primary end points were new vertebral fracture (in patients not taking concomitant osteoporosis medications) and hip fracture (in all patients). Secondary end points included bone mineral density, bone turnover markers, and safety outcomes. Results Treatment with Zoledronic Acid reduced the risk of morphometric vertebral fracture by 70% during a 3-year period, as compared with placebo (3.3% in the Zoledronic-Acid group vs. 10.9% in the ...
C Mautalen - One of the best experts on this subject based on the ideXlab platform.
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Zoledronic Acid and clinical fractures and mortality after hip fracture
The New England Journal of Medicine, 2007Co-Authors: Kenneth W Lyles, C Mautalen, Cathleen S Colonemeric, Jay Magaziner, Jonathan D Adachi, Carl F Pieper, Lars Hyldstrup, Chris Recknor, Lars Nordsletten, Kathy A MooreAbstract:In this randomized, double-blind, placebo-controlled trial, 1065 patients were assigned to receive yearly intravenous Zoledronic Acid (at a dose of 5 mg), and 1062 patients were assigned to receive placebo. The infusions were first administered within 90 days after surgical repair of a hip fracture. All patients (mean age, 74.5 years) received supplemental vitamin D and calcium. The median follow-up was 1.9 years. The primary end point was a new clinical fracture. Results The rates of any new clinical fracture were 8.6% in the Zoledronic Acid group and 13.9% in the placebo group, a 35% risk reduction with Zoledronic Acid (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 nonvertebral fractures were 7.6% and 10.7% (P = 0.03). In the safety analysis, 101 of 1054 patients in the Zoledronic Acid 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 Zoledronic Acid group (P = 0.01). The most frequent adverse events in patients receiving Zoledronic Acid were pyrexia, myalgia, and bone and musculoskeletal pain. No cases of osteonecrosis of the jaw were reported, and no adverse effects on the healing of fractures were noted. The rates of renal and cardiovascular adverse events, including atrial fibrillation and stroke, were similar in the two groups. Conclusions An annual infusion of Zoledronic Acid within 90 days after repair of a low-trauma hip fracture was associated with a reduction in the rate of new clinical fractures and with improved survival. (ClinicalTrials.gov number, NCT00046254.)
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once yearly Zoledronic Acid for treatment of postmenopausal osteoporosis
The New England Journal of Medicine, 2007Co-Authors: Dennis M Black, Pierre D Delmas, R Eastell, Ian R Reid, Steven Boonen, Jane A Cauley, Felicia Cosman, Peter L Lakatos, Ping Chung Leung, C MautalenAbstract:Background A single infusion of intravenous Zoledronic Acid decreases bone turnover and improves bone density at 12 months in postmenopausal women with osteoporosis. We assessed the effects of annual infusions of Zoledronic Acid on fracture risk during a 3-year period. Methods In this double-blind, placebo-controlled trial, 3889 patients (mean age, 73 years) were randomly assigned to receive a single 15-minute infusion of Zoledronic Acid (5 mg) and 3876 were assigned to receive placebo at baseline, at 12 months, and at 24 months; the patients were followed until 36 months. Primary end points were new vertebral fracture (in patients not taking concomitant osteoporosis medications) and hip fracture (in all patients). Secondary end points included bone mineral density, bone turnover markers, and safety outcomes. Results Treatment with Zoledronic Acid reduced the risk of morphometric vertebral fracture by 70% during a 3-year period, as compared with placebo (3.3% in the Zoledronic-Acid group vs. 10.9% in the ...
V Bjelicradisic - One of the best experts on this subject based on the ideXlab platform.
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endocrine therapy plus Zoledronic Acid in premenopausal breast cancer
Obstetrical & Gynecological Survey, 2009Co-Authors: Michael Gnant, B Mlineritsch, Walter Schippinger, G Luschinebengreuth, Sabine Postlberger, C Menzel, R Jakesz, M Seifert, Michael Hubalek, V BjelicradisicAbstract:The combination of ovarian suppression and tamoxifen is a standard adjuvant endocrine therapy in premenopausal women with endocrine-responsive breast cancer. Several reports have demonstrated that adjuvant endocrine therapy with aromatase inhibitors is superior to endocrine therapy with tamoxifen in postmenopausal women with endocrine-responsive breast cancer. The benefits of aromatase inhibitors, however, in premenopausal women are largely unknown. Previous studies showing that bisphosphonate therapy with Zoledronic Acid had antitumor and antimetastatic properties and prevented aromatase inhibitor-associated bone loss were the basis for the Austrian Breast and Colorectal Cancer Study Group trial 12. This randomized trial was part of the Austrian Breast and Colorectal Cancer Study Group trial 12 and investigated the possible benefits of adding Zoledronic Acid to adjuvant endocrine therapy with either Anastrozole or Tamoxifen in premenopausal women with endocrine-responsive early breast cancer. After primary surgery, 1803 patients were randomized to receive goserelin plus tamoxifen with (n = 449) or without (n = 451) Zoledronic Acid or goserelin plus anastrozole with (n = 450) or without (n = 453) Zoledronic Acid for 3 years. The primary end-point was disease-free survival, defined as the first occurrence of one or more of the following event(s): death from any cause, local or regional relapse, distant metastasis, contralateral breast cancer, and a second primary tumor. Secondary end points were recurrence-free survival and overall survival. At a median follow-up of 47.8 months, 137 events met the criteria for the primary end point. No significant difference in disease-free survival was found between the goserelin/anastrozole and goserelin/tamoxifen groups (92.0% vs. 92.8%, respectively); the hazard ratio (HR) for disease progression was 1.10, with a 95% confidence interval [CI] of 0.78―1.53; P = 0.59. Rates of recurrence-free survival and overall survival also did not differ among the 2 groups. The addition of Zoledronic Acid to adjuvant endocrine therapy significantly improved disease-free survival at 47.8 months; 94.0% of patients receiving Zoledronic Acid were free of disease compared to 90.8% of those receiving adjuvant endocrine therapy alone (HR, 0.64; 95% CI, 0.46―0.91; P = 0.01). No significant reduction in the risk of death was associated by adding Zoledronic Acid to adjuvant endocrine treatment (HR, 0.60; 95% CI, 0.32―1.11; P = 0.11). Overall, adverse events were as expected and no increase in serious adverse events or treatment-related deaths occurred. These data show that addition of Zoledronic Acid to adjuvant endocrine therapy improves disease-free survival in a population of premenopausal women with endocrine-responsive early breast cancer.
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endocrine therapy plus Zoledronic Acid in premenopausal breast cancer
The New England Journal of Medicine, 2009Co-Authors: Michael Gnant, B Mlineritsch, Walter Schippinger, G Luschinebengreuth, Sabine Postlberger, C Menzel, R Jakesz, M Seifert, Michael Hubalek, V BjelicradisicAbstract:After a median follow-up of 47.8 months, 137 events had occurred, with disease-free survival rates of 92.8% in the tamoxifen group, 92.0% in the anastrozole group, 90.8% in the group that received endocrine therapy alone, and 94.0% in the group that received endocrine therapy with Zoledronic Acid. There was no significant dif ference in disease-free survival between the anastrozole and tamoxifen groups (haz ard ratio for disease progression in the anastrozole group, 1.10; 95% confidence in terval [CI], 0.78 to 1.53; P = 0.59). The addition of Zoledronic Acid to endocrine therapy, as compared with endocrine therapy without Zoledronic Acid, resulted in an absolute reduction of 3.2 percentage points and a relative reduction of 36% in the risk of dis ease progression (hazard ratio, 0.64; 95% CI, 0.46 to 0.91; P = 0.01); the addition of Zoledronic Acid did not significantly reduce the risk of death (hazard ratio, 0.60; 95% CI, 0.32 to 1.11; P = 0.11). Adverse events were consistent with known drug-safety profiles. Conclusions The addition of Zoledronic Acid to adjuvant endocrine therapy improves disease-free survival in premenopausal patients with estrogen-responsive early breast cancer. (ClinicalTrials.gov number, NCT00295646.)
Ian R Reid - One of the best experts on this subject based on the ideXlab platform.
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effects of intravenous Zoledronic Acid once yearly on bone remodeling and bone structure
Journal of Bone and Mineral Research, 2007Co-Authors: Robert R Recker, Pierre D Delmas, Ian R Reid, Steven Boonen, Johan Halse, Pedro A Garciahernandez, Jerzy Supronik, Michael E Lewiecki, Luis Ochoa, Paul D MillerAbstract:In a substudy of the HORIZON pivotal fracture trial, in which yearly intravenous Zoledronic Acid 5 mg was found to significantly reduce risk of various fracture types in patients with postmenopausal osteoporosis, 152 patients underwent bone biopsy. Zoledronic Acid reduced bone turnover by 63% and preserved bone structure and volume, with evidence of ongoing bone remodeling in 99% of biopsies obtained. Introduction: In the HORIZON pivotal fracture trial (PFT), enrolling 7736 women with postmenopausal osteoporosis, three annual intravenous infusions of the bisphosphonate Zoledronic Acid (5 mg) significantly reduced morphometric vertebral, clinical vertebral, hip, and nonvertebral fractures by 70%, 77%, 41%, and 25%, respectively. Whereas 79% of patients received Zoledronic Acid/placebo only (stratum I, n = 6113), 21% received concomitant treatment with other antiresorptive drugs, excluding other bisphosphonates, PTH, and strontium (stratum II, n = 1652). Materials and Methods: To determine effects on bone remodeling and bone architecture, iliac crest bone biopsies were obtained in 152 patients on active treatment or placebo at 3 yr after double tetracycline labeling. In five patients, only qualitative histology was performed, leaving 147 biopsy cores (79 on active treatment and 68 on placebo) for νCT analysis and histomorphometry. Results: Analysis of bone structure by νCT revealed higher trabecular bone volume (BV/TV) in the Zoledronic Acid group (median, 16.6% versus 12.8%; p = 0.020). In addition, patients treated with Zoledronic Acid exhibited higher trabecular numbers (p = 0.008), decreased trabecular separation (p = 0.011), and a trend toward improvement in connectivity density (p = 0.062), all indicating better preservation of trabecular structure after treatment with Zoledronic Acid. Qualitative analysis revealed presence of tetracycline label in 81 of 82 biopsies from patients on Zoledronic Acid and all 70 biopsies from placebo patients, indicative of continued bone remodeling. No bone pathology was observed. Zoledronic Acid induced a 63% median (71% mean) reduction of the activation frequency (Ac.f; p < 0.0001) and reduced mineralizing surface (MS/BS; p < 0.0001) and volume referent bone formation rate (BFR/BV) versus placebo, indicating reduced bone turnover. Mineral appositional rate was higher in the Zoledronic Acid group (p = 0.0002), suggesting improved osteoblast function compared with placebo. Mineralization lag time was similar in the two groups, whereas osteoid volume (OV/BV; p < 0.0001) and osteoid thickness (O. Th; p = 0.0094) were lower in Zoledronic Acid-treated patients, indicating normal osteoid formation and mineralization of newly formed bone. Concomitant administration of other antiresorptive osteoporosis therapies (e.g., raloxifene, tamoxifen, tibolone, ipriflavone) did not significantly alter the tissue level response to Zoledronic Acid. Conclusions: Annual dosing for 3 yr with Zoledronic Acid 5 mg intravenously resulted in a median 63% (mean, 71%) reduction of bone turnover and preservation of bone structure and mass without any signs of adynamic bone. Concomitant treatment with other osteoporosis therapies did not significantly affect the bone response to Zoledronic Acid.
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once yearly Zoledronic Acid for treatment of postmenopausal osteoporosis
The New England Journal of Medicine, 2007Co-Authors: Dennis M Black, Pierre D Delmas, R Eastell, Ian R Reid, Steven Boonen, Jane A Cauley, Felicia Cosman, Peter L Lakatos, Ping Chung Leung, C MautalenAbstract:Background A single infusion of intravenous Zoledronic Acid decreases bone turnover and improves bone density at 12 months in postmenopausal women with osteoporosis. We assessed the effects of annual infusions of Zoledronic Acid on fracture risk during a 3-year period. Methods In this double-blind, placebo-controlled trial, 3889 patients (mean age, 73 years) were randomly assigned to receive a single 15-minute infusion of Zoledronic Acid (5 mg) and 3876 were assigned to receive placebo at baseline, at 12 months, and at 24 months; the patients were followed until 36 months. Primary end points were new vertebral fracture (in patients not taking concomitant osteoporosis medications) and hip fracture (in all patients). Secondary end points included bone mineral density, bone turnover markers, and safety outcomes. Results Treatment with Zoledronic Acid reduced the risk of morphometric vertebral fracture by 70% during a 3-year period, as compared with placebo (3.3% in the Zoledronic-Acid group vs. 10.9% in the ...
Pierre D Delmas - One of the best experts on this subject based on the ideXlab platform.
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Potential mediators of the mortality reduction with Zoledronic Acid after hip fracture
Journal of Bone and Mineral Research, 2009Co-Authors: Cathleen S. Colón-emeric, Pierre D Delmas, Steven Boonen, Kenneth W Lyles, Carl F Pieper, Peter Mesenbrink, Erik Fink Eriksen, Jay MagazinerAbstract:Zoledronic Acid reduces the risk of death by 28% after hip fracture, but the mechanisms are not known. This exploratory analysis sought to identify potential pathways for the reduction in mortality with Zoledronic Acid after hip fracture. This was a retrospective analysis of a randomized, controlled trial. Patients with recent hip fracture (n = 2111) were treated with Zoledronic Acid or placebo infusion yearly, as well as calcium and vitamin D supplementation. Causes of death were adjudicated by a blinded central review committee. Baseline comorbidities, events occurring during the study period, including subsequent fracture, change in bone density, infections, cardiovascular events, arrhythmias, and falls, were included in multivariable analyses. In a model adjusted for baseline risk factors, Zoledronic Acid reduced the risk of death by 25% [95% confidence interval (CI) 0.58-0.97). The effect was consistent across most subgroups. Subsequent fractures were significantly associated with death (hazard ratio 1.72, 95% CI 1.17-2.51) but explained only 8% of the Zoledronic Acid effect. Adjusting for acute events occurring during follow-up eliminated the death benefit, and Zoledronic Acid-treated subjects were less likely to die from pneumonia (interaction p = .04) and arrhythmias (interaction p = .02) than placebo-treated subjects. Only 8% of Zoledronic Acid's death benefit is due to a reduction in secondary fractures. Zoledronic Acid may have an effect on cardiovascular events and pneumonia. Further studies of Zoledronic Acid in other acute illnesses may be warranted.
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effects of intravenous Zoledronic Acid once yearly on bone remodeling and bone structure
Journal of Bone and Mineral Research, 2007Co-Authors: Robert R Recker, Pierre D Delmas, Ian R Reid, Steven Boonen, Johan Halse, Pedro A Garciahernandez, Jerzy Supronik, Michael E Lewiecki, Luis Ochoa, Paul D MillerAbstract:In a substudy of the HORIZON pivotal fracture trial, in which yearly intravenous Zoledronic Acid 5 mg was found to significantly reduce risk of various fracture types in patients with postmenopausal osteoporosis, 152 patients underwent bone biopsy. Zoledronic Acid reduced bone turnover by 63% and preserved bone structure and volume, with evidence of ongoing bone remodeling in 99% of biopsies obtained. Introduction: In the HORIZON pivotal fracture trial (PFT), enrolling 7736 women with postmenopausal osteoporosis, three annual intravenous infusions of the bisphosphonate Zoledronic Acid (5 mg) significantly reduced morphometric vertebral, clinical vertebral, hip, and nonvertebral fractures by 70%, 77%, 41%, and 25%, respectively. Whereas 79% of patients received Zoledronic Acid/placebo only (stratum I, n = 6113), 21% received concomitant treatment with other antiresorptive drugs, excluding other bisphosphonates, PTH, and strontium (stratum II, n = 1652). Materials and Methods: To determine effects on bone remodeling and bone architecture, iliac crest bone biopsies were obtained in 152 patients on active treatment or placebo at 3 yr after double tetracycline labeling. In five patients, only qualitative histology was performed, leaving 147 biopsy cores (79 on active treatment and 68 on placebo) for νCT analysis and histomorphometry. Results: Analysis of bone structure by νCT revealed higher trabecular bone volume (BV/TV) in the Zoledronic Acid group (median, 16.6% versus 12.8%; p = 0.020). In addition, patients treated with Zoledronic Acid exhibited higher trabecular numbers (p = 0.008), decreased trabecular separation (p = 0.011), and a trend toward improvement in connectivity density (p = 0.062), all indicating better preservation of trabecular structure after treatment with Zoledronic Acid. Qualitative analysis revealed presence of tetracycline label in 81 of 82 biopsies from patients on Zoledronic Acid and all 70 biopsies from placebo patients, indicative of continued bone remodeling. No bone pathology was observed. Zoledronic Acid induced a 63% median (71% mean) reduction of the activation frequency (Ac.f; p < 0.0001) and reduced mineralizing surface (MS/BS; p < 0.0001) and volume referent bone formation rate (BFR/BV) versus placebo, indicating reduced bone turnover. Mineral appositional rate was higher in the Zoledronic Acid group (p = 0.0002), suggesting improved osteoblast function compared with placebo. Mineralization lag time was similar in the two groups, whereas osteoid volume (OV/BV; p < 0.0001) and osteoid thickness (O. Th; p = 0.0094) were lower in Zoledronic Acid-treated patients, indicating normal osteoid formation and mineralization of newly formed bone. Concomitant administration of other antiresorptive osteoporosis therapies (e.g., raloxifene, tamoxifen, tibolone, ipriflavone) did not significantly alter the tissue level response to Zoledronic Acid. Conclusions: Annual dosing for 3 yr with Zoledronic Acid 5 mg intravenously resulted in a median 63% (mean, 71%) reduction of bone turnover and preservation of bone structure and mass without any signs of adynamic bone. Concomitant treatment with other osteoporosis therapies did not significantly affect the bone response to Zoledronic Acid.
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once yearly Zoledronic Acid for treatment of postmenopausal osteoporosis
The New England Journal of Medicine, 2007Co-Authors: Dennis M Black, Pierre D Delmas, R Eastell, Ian R Reid, Steven Boonen, Jane A Cauley, Felicia Cosman, Peter L Lakatos, Ping Chung Leung, C MautalenAbstract:Background A single infusion of intravenous Zoledronic Acid decreases bone turnover and improves bone density at 12 months in postmenopausal women with osteoporosis. We assessed the effects of annual infusions of Zoledronic Acid on fracture risk during a 3-year period. Methods In this double-blind, placebo-controlled trial, 3889 patients (mean age, 73 years) were randomly assigned to receive a single 15-minute infusion of Zoledronic Acid (5 mg) and 3876 were assigned to receive placebo at baseline, at 12 months, and at 24 months; the patients were followed until 36 months. Primary end points were new vertebral fracture (in patients not taking concomitant osteoporosis medications) and hip fracture (in all patients). Secondary end points included bone mineral density, bone turnover markers, and safety outcomes. Results Treatment with Zoledronic Acid reduced the risk of morphometric vertebral fracture by 70% during a 3-year period, as compared with placebo (3.3% in the Zoledronic-Acid group vs. 10.9% in the ...
