Evidences of safety and tolerability of the zoledronic acid 5 mg yearly in the post-menopausal osteoporosis: The HORIZON project;Evidenze di sicurezza e tollerabilità dell'acido zoledronico 5 mg una volta all'anno nell'osteoporosi postmenopausale: Il progetto HORIZON

Reumatismo

Volumn 61, Issue 1, 2009, Pages 54-64

  Dalle Carbonare, Luca ^a   Bertoldo, F ^a   Lo Cascio, V ^a  

^a UNIVERSITY OF VERONA   (Italy)

Author keywords

Acido zoledronico; Istomorfometria; Modeling; ONJ; Sicurezza

Indexed keywords

ALENDRONIC ACID; BISPHOSPHONIC ACID DERIVATIVE; IBANDRONIC ACID; PLACEBO; RISEDRONIC ACID; ZOLEDRONIC ACID; BONE DENSITY CONSERVATION AGENT; IMIDAZOLE DERIVATIVE;

ARTHRALGIA; ARTICLE; BONE DENSITY; BONE MARROW BIOPSY; BONE MASS; BONE METASTASIS; BONE MINERALIZATION; BONE STRUCTURE; BONE TURNOVER; CLINICAL TRIAL; DISLOCATION; DOSE RESPONSE; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG EXCRETION; DRUG MEGADOSE; DRUG SAFETY; DRUG TOLERABILITY; FEMUR FRACTURE; FEVER; FLU LIKE SYNDROME; HEADACHE; HEART ATRIUM FIBRILLATION; HUMAN; JAW OSTEONECROSIS; MICRO-COMPUTED TOMOGRAPHY; MINERAL APPOSITIONAL RATE; MORPHOMETRICS; MULTIPLE MYELOMA; MUSCULOSKELETAL SYSTEM PARAMETERS; MYALGIA; NEPHROTOXICITY; OSSIFICATION; PATIENT COMPLIANCE; POSTMENOPAUSE OSTEOPOROSIS; TRABECULAR BONE; VERTEBRA FRACTURE; BIOPSY; BONE; CHEMICALLY INDUCED DISORDER; COMPARATIVE STUDY; FEMALE; FOLLOW UP; INTRAVENOUS DRUG ADMINISTRATION; KIDNEY FAILURE; METABOLISM; MULTICENTER STUDY; PATHOLOGY; RANDOMIZED CONTROLLED TRIAL; RETROSPECTIVE STUDY; RISK FACTOR; SAFETY; SPINE FRACTURE; TIME;

ATRIAL FIBRILLATION; BIOPSY; BONE AND BONES; BONE DENSITY; BONE DENSITY CONSERVATION AGENTS; DIPHOSPHONATES; FEMALE; FEMORAL FRACTURES; FOLLOW-UP STUDIES; HUMANS; IMIDAZOLES; INFUSIONS, INTRAVENOUS; MULTICENTER STUDIES AS TOPIC; OSTEOPOROSIS, POSTMENOPAUSAL; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RENAL INSUFFICIENCY; RETROSPECTIVE STUDIES; RISK FACTORS; SAFETY; SPINAL FRACTURES; TIME FACTORS;

EID: 66149143623     PISSN: 00487449     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (50)

1. Parfitt AM. in: Recker RR (ed.) Bone Histomorphometry: Techniques and Interpretation. The physiologic and clinical significance of bone histomorphometric data. CRC Press, Boca Raton, FL, USA, 1983, 143-224.
2. Parfitt AM, Drezner MK, Glorieux FH, Kanis JA, Malluche H, Meunier PJ, et al. Bone Histomorphometry: standardization of nomenclature, symbols, and units. J Bone Miner Res 1987; 2: 595-610.
3. Feldkamp LA, Goldstein SA, Parfitt AM, Jesion G, Kleerekoper M. The direct examination of three-dimensional bone architecture in vitro by computed tomography. J Bone Miner Res 1989; 4: 3-11.
4. Legrand E, Chappard D, Pascaretti C, Duquenne M, Krebs S, Rohmer V, et al. Trabecular bone microarchitecture, bone mineral density, and vertebral fractures in male osteoporosis. J Bone Miner Res 2000; 15: 13-9.
5. Dalle Carbonare L, Valenti MT, Bertoldo F, Zanatta M, Zenari S, Realdi G, et al. Bone microarchitecture evaluated by histomorphometry. Micron 2005; 36: 609-16.
6. Arlot M, Meunier PJ, Boivin G, Haddock L, Tamayo J, Correa-Rotter R, et al. Differential effects of teriparatide and alendronate on bone remodeling in postmenopausal women assessed by histomorphometric parameters. J Bone Miner Res 2005; 20: 1244-53.
7. Black DM, Delmas PD, Eastell R, Reid IR, Boonen S, Cauley JA, et al. for the HORIZON Pivotal Fracture Trial. Once-Yearly Zoledronic Acid for Treatment of Postmenopausal Osteoporosis. N Engl J Med 2007; 356: 1809-22.
8. Lyles KW, Colón-Emeric CS, Magaziner JS, Adachi JD, Pieper CF, Mautalen C, et al. for the HORIZON Re-current Fracture Trial. Zoledronic Acid and Clinical Fractures and Mortality after Hip Fracture. N Engl J Med 2007; 357: 1799-809.
9. Recker RR, Delmas PD, Halse J, Reid IR, Boonen S, García-Hernandez PA, et al. Effects of Intravenous Zoledronic Acid Once Yearly on Bone Remodeling and Bone Structure. J Bone Miner Res 2008; 23: 6-16.
10. Chavassieux PM, Arlot ME, Reda C, Wei L, Yates AJ, Meunier PJ. Histomorphomtric assessment of the longterm effects of alendronate on bone quality and remodeling in patients with osteoporosis. J Clin Invest 1997; 100: 1475-80.
11. Recker RR, Weinstein RS, Chesnut CH 3rd, Schimmer RC, Mahoney P, Hughes C, et al. Histomorphometric evaluation of daily and intermittent oral ibandronate in women with postmenopausal osteoporosis: results from the BONE study. Osteoporos Int 2004; 15: 231-7.
12. Eriksen EF, Melsen F, Sod E, Barton I, Chines A. Effects of long-term risedronate on bone quality and bone turnover in women with postmenopausal osteoporosis. Bone 2002; 31: 620-5.
13. Boivin G, Meunier PJ. The degree of mineralization of bone tissue measured by computerized quantitative contact microradiography. Calcif Tissue Int 2002; 70: 503-11.
14. Ebeling PR, Burr DB. Positive effects of intravenous zoledronic acid on bone remodeling and structure: are different effects on osteoblast activity to other oral bisphosphonates responsible? J Bone Miner Res 2008; 23: 2-5.
15. Hauge E, Mosekilde LE, Melsen F. Missing observations in bone histomorphometry on osteoporosis: implications and suggestions for an approach. Bone 1999; 25: 389-95.
16. Plotkin LI, Weinstein RS, Parfitt AM, Roberson PK, Manolagas SC, Bellido T. Prevention of osteocyte and osteoblast apoptosis by bisphosphonates and calcitonin. J Clin Invest 1999; 104: 1363-74.
17. Im GI, Qureshi SA, Kenney J, Rubash HE, Shanbhag AS. Osteoblast proliferation and maturation by bisphosphonates. Biomaterials 2004; 25: 4105-15.
18. Seeman E, Compston J, Adachi J, Brandi ML, Cooper C, Dawson-Hughes B, et al. Non-compliance: the Achilles' heel of antifracture efficacy. Osteorporos Int 2007; 18: 711-9.
19. Rossini M, Bianchi G, Di Munno O, Giannini S, Minisola S, Sinigaglia L, et al. Treatment of Osteoporosis in clinical Practice (TOP) Study Group. Determinants of adherence to osteoporosis treatment in clinical practice. Osteoporos Int 2006;
20. Hamilton B, McCoy K, Taggart H. Tolerability and compliance with risedronate in clinical practice. Osteoporos Int 2003; 14: 259-8.
21. Siris ES, Harris ST, Rosen CJ, Barr CE, Arvesen JN, Abbott TA, et al. Adherence to bisphosphonate therapy and fracture rates in osteoporotic women. Relationship top vertebral and non vertebral fractures from 2 US Claims databases. Mayo Clin Proc 2006; 81: 1013-22.
22. Tosteson AN, Grove MR, Hammond CS, Moncur MM, Ray GT, Hebert GM, et al. Early discontinuation of treatment for osteoporosis. Am J Med 2003; 115: 209-16.
23. Dhillon S, Lyseng-Williamson KA. Zoledronic acid: a review of its use in the management of bone metastases of malignancy. Drugs 2008; 68: 507-34.
24. Adami S, Zamberlan N. Adverse effect of bisphosphonates: a comparative review. Drug Saf 1996; 14: 158-70.
25. Strampel W, Emkey R, Civitelli R. Safety considerations with bisphosphonates for the treatment of osteoporosis. Drug Saf 2007; 30: 755-63.
26. Hewitt RE, Lissina A, Green AE, Slay ES, Price DA, Sewell AK. The bisphosphonate acute phase response: rapid and copious production of proinflammatory cytokines by peripheral blood gd T cells in response to aminobisphosphonates is inhibited by statins. Clin Exp Immunol 2005; 139: 101-11.
27. Caccamo N, Meraviglia S, Scarpa F, La Mendola C, Santini D, Bonanno CT, et al. Aminobisphosphonateactivated gammadelta T cells in immunotherapy of cancer: doubts no more. Expert Opin Biol Ther 2008; 8: 875-83.
28. Lühe A, Künkele KP, Haiker M, Schad K, Zihlmann C, Bauss F, et al. Preclinical evidence for nitrogen-containing bisphosphonate inhibition of farnesyl biphosphonate (FPP) synthase in the kidney: implications for renal safety. Toxicology in vitro 2008; 22: 899-909.
29. Conte PF, Guarnieri V. Safety of intravenous and oral bisphosponates and compliance with dosing regimens. Oncologist 2004; 9: 28-37.
30. Ibrahim A, Scher N, Williams G, Sridhara R, Li N, Chen G, et al. Approval summary for zoledronic acid for treatment of multiple myeloma and cancer bone metastases. Clin Cancer Res 2003; 9: 2394-9.
31. Boonen S, Sellmeyer DE, Lippuner K Orlov-Morozov A, Abrams K, Mesenbrink P, et al. Renal safety of annual zoledronic acid infusions in osteoporotic postmenopausal women. Kidney Int 2008; 74: 641-8.
32. Chen T, Berenson J, Vescio R, Swift R, Gilchick A, Goodin S, et al. Pharmaookinetics and pharmacodynamics of zoledronic acid in cancer patients with bone metastases J Clin Pharmacol 2002; 43: 154-62.
33. Skerjanec C, Berenson J, Hsu C Major P, Miller WH Jr, Ravera C, et al. The pharmacokinetics and pharmacodynamics in cancer patients with varying degrees of renal function. J Clin Pharmacol 2003; 42: 1228-36.
34. Cummings SR, Schwartz AV, Black DM. Alendronate and atrial fibrillation 5 [letter]. N Engl J Med 2007; 356: 1895-6.
35. Sørensen HT, Christensen S, Mehnert F, Pedersen L, Chapurlat RD, Cummings SR, et al. Use of bisphosphonates among women and risk of atrial fibrillation and flutter: population based case-control study. BMJ 2008; 336: 813-6.
36. Heckbert S, Li G, Cummings SR, Smith NL, Psaty BM. Use of alendronate and risk of incident atrial fibrillation in women Arch Intern Med 2008; 168: 826-31.
37. Aviles RJ, Martin DO, Apperson-Hansen C, Houghtaling PL, Rautaharju P, Kronmal RA, et al. Inflammation as a risk factor for atrial fibrillation. Circulation 2003; 108: 3006-10.
38. Van Wagoner DR, Nerbonne JM. Molecular basis of electrical remodeling in atrial fibrillation J Mol Cell Cardiol 2000; 32: 1101-17.
39. Bertoldo F, Santini D, Lo Cascio V. Bisphosphonates and osteomyelitis of the jaw: a pathogenic puzzle. Nat Clin Pract Oncol. 2007; 4: 711-21.
40. Felsemberg D, Hoffmeister B, Amling M. Onkologie: Kiefernekrosen nach hoch dosierter Bisphosphonat-therapie. Deutsches Arzteblatt 2006; 103: 3078-81.
41. Sambrook P, Olver I, Goss A. Bisphosphonates and osteonecrosis of the jaw. Aust Fam Physician 2006; 35: 801-3.
42. Bertoldo F. Bisphosphonates and osteonecrosis of the mandible/maxilla in osteoporosis: no reason to panic. Aging Clin Exp Res 2008; 20: 87-90.
43. Grbic JT, Landesberg R, Lin SQ, Mesenbrink P, Reid IR, Leung PC, et al. Incidence of osteonecrosis of the jaw in women with postmenopausal osteoporosis in the health outcomes and reduced incidence with zoledronic acid once yearly pivotal fracture trial. JADA 2008; 39: 32-40.
44. Khosla S, Burr D, Cauley J, Dempster DW, Ebeling PR, Felsenberg D, et al. Bisphosphonates-Associated Osteonecrosis of the Jaw: report of a task force of the American Society for Bone and Mineral Research. ASBMR Task Force on Bisphosphonate-Associated ONJ. J Bone Miner Res 2007; 22: 1479-91.
45. Badros A, Weikel D, Salama A, Goloubeva O, Schneider A, Rapoport A, et al. Osteonecrosis of the jaw in multiple myeloma patients: clinical features and risk factors. J Clin Oncol 2006; 24: 945-52.
46. Ruggiero SL, Mehrotra B, Rosenberg TJ, Engroff SL. Osteonecrosis of the jaw associated with the use of bisphosphonates: a review of 63 cases. J Oral Maxillofac Surg 2004; 62: 527-34.
47. Marx RE, Cillo JE, Ulloa JJ. Oral bisphosphonate-induced osteonecrosis: risk factors, prediction of risk using serum CTX testing, prevention and treatment J Oral Maxillofac Surg 2007; 65: 2397-2410.
48. Bedogni A, Blandamura S, Lokmic Z, Palumbo C, Ragazzo M, Ferrari F, et al. Bisphosphonate-associated jawbone osteonecrosis: a correlation between imaging techniques and histopathology. Oral Surg Oral Med Oral Pathol Oral Radiol Endod 2008;105: 358-64.
49. Cartsos VM, Zhu S, Zavras AI. Bisphosphonate use and the risk of adverse jaw outcomes: a medical claims study of 714,217 people. J Am Dent Assoc 2008; 139: 23-30.
50. Yarom N, Yahalom R, Shoshani Y, Hamed W, Regev E, Elad S. Osteonecrosis of the jaw induced by orally administered bisphosphonates: incidence, clinical features, predisposing factors and treatment outcome. Osteoporos Int 2007; 18: 1363-70.