Renal tolerability of intermittent intravenous ibandronate treatment for patients with postmenopausal osteoporosis: A review

Clinical and Experimental Rheumatology

Volumn 26, Issue 6, 2008, Pages 1125-1133

  Miller, P D ^a   Ward, P ^b   Pfister, T ^b   Leigh, C ^b   Body, Jean Jacques ^c  

^a University of Colorado Health Sciences Center   (United States)

^b F HOFFMANN LA ROCHE LTD   (Switzerland)

^c BRUGMANN UNIVERSITY HOSPITAL   (Belgium)

Author keywords

Ibandronate; Intravenous; Renal; Safety; Tolerability

Indexed keywords

ALENDRONIC ACID; ALFACALCIDOL; BISPHOSPHONIC ACID DERIVATIVE; CLODRONIC ACID; CORTICOSTEROID; ETIDRONIC ACID; IBANDRONIC ACID; PAMIDRONIC ACID; PLACEBO; RISEDRONIC ACID; TILUDRONIC ACID; ZOLEDRONIC ACID;

ACUTE KIDNEY FAILURE; AREA UNDER THE CURVE; BONE DENSITY; BONE METASTASIS; CELL LEVEL; CLINICAL EFFECTIVENESS; CLINICAL TRIAL; COMORBIDITY; CORTICOSTEROID INDUCED OSTEOPOROSIS; CREATININE BLOOD LEVEL; CREATININE CLEARANCE; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG CONTRAINDICATION; DRUG DOSAGE FORM COMPARISON; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG EXCRETION; DRUG INDICATION; DRUG INTERMITTENT THERAPY; DRUG MECHANISM; DRUG MEGADOSE; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; FOLLOW UP; GASTROINTESTINAL SYMPTOM; GLOMERULUS FILTRATION RATE; HUMAN; HYPERCALCEMIA; KIDNEY BLOOD FLOW; KIDNEY DYSFUNCTION; KIDNEY FAILURE; KIDNEY INJURY; KIDNEY TUBULE DAMAGE; MAXIMUM PLASMA CONCENTRATION; NEPHROTOXICITY; NONHUMAN; OPTIMAL DRUG DOSE; POSTMARKETING SURVEILLANCE; POSTMENOPAUSE OSTEOPOROSIS; PRIORITY JOURNAL; REVIEW; RISK REDUCTION; SECONDARY OSTEOPOROSIS; SIDE EFFECT; SINGLE DRUG DOSE; URINALYSIS; URINARY TRACT INFECTION; VERTEBRA FRACTURE;

BONE DENSITY CONSERVATION AGENTS; DIPHOSPHONATES; FEMALE; HUMANS; INFUSIONS, INTRAVENOUS; KIDNEY; KIDNEY DISEASES; OSTEOPOROSIS, POSTMENOPAUSAL; PRODUCT SURVEILLANCE, POSTMARKETING;

EID: 49649109846     PISSN: 0392856X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (51)

1. NIH CONSENSUS DEVELOPMENT PANEL: Osteoporosis prevention, diagnosis, and therapy. JAMA 2001; 285: 785-95.
2. BLACK DM, CUMMINGS SR, KARPF DB et al.: Randomised trial of effect of alendronate on risk of fracture in women with existing vertebral fractures. Fracture Intervention Trial Research Group. Lancet 1996; 348: 1535-41.
3. CHESNUT CH, SKAG A, CHRISTIANSEN C et al.: Effects of oral ibandronate administered daily or intermittently on fracture risk in postmenopausal osteoporosis. J Bone Miner Res 2004; 19: 1241-9.
4. HARRIS ST, WATTS NB, GENANT HK et al.: Effects of risedronate treatment on vertebral and nonvertebral fractures in women with postmenopausal osteoporosis: A randomized controlled trial. Vertebral Efficacy With Risedronate Therapy (VERT) Study Group. JAMA 1999; 282: 1344-52.
5. REGINSTER J, MINNE HW, SORENSEN OH et al.: Randomized trial of the effects of risedronate on vertebral fractures in women with established postmenopausal osteoporosis. Vertebral Efficacy with Risedronate Therapy (VERT) Study Group. Osteoporos Int 2000; 11: 83-91.
6. BAUER DC, BLACK D, ENSRUD K et al.: Upper gastrointestinal tract safety profile of alendronate: The fracture intervention trial. Arch Intern Med 2000; 160: 517-25.
7. DELANEY M, HURWITZ S, SHAW J et al.: Bone density changes with once weekly risedronate in postmenopausal women. J Clin Densitom 2003; 6: 45-50.
8. ETTINGER B, PRESSMAN A, SCHEIN J et al.: Alendronate use among 812 women: Prevalence of gastrointestinal complaints, noncompliance with patient instructions, and discontinuation. J Manag Care Pharm 1998; 4: 488-92.
9. LUFKIN AG, ARGUETA R, WHITAKER MD et al.: Pamidronate: an unrecognized problem in gastrointestinal tolerability. Osteoporos Int 1994; 4: 320-2.
10. SIRIS E, WEINSTEIN RS, ALTMAN R et al.: Comparative study of alendronate versus etidronate for the treatment of Paget's disease of bone. J Clin Endocrinol Metab 1996; 81: 961-7.
11. BODY JJ, DIEL JJ, LICHINITSER MR et al.: Intravenous ibandronate reduces the incidence of skeletal complications in patients with breast cancer and bone metastases. Ann Oncol 2003; 14: 1399-405.
12. BODY J-J, KANIS JA, BERGSTROM B: Risk reductions in metastatic breast cancer: Multivariate Poisson regression analyses of oral and IV ibandronate. Proc Am Soc Clin Oncol 2003; 22: 46 (Abstract 184).
13. FINLAY R: The use of bisphosphonates in the treatment of bone metastases. Semin Oncol 2002; 29(Suppl. 4): 652-60.
14. OHLMANN C, HEIDENREICH A: Efficacy of ibandronate in the management of painful osseous matastases due to hormone refractory prostate cancer. Support Care Cancer 2003; 11: 396 (Abstract A-38).
15. ROGERS MJ, WATTS DJ, RUSSELL RG: Overview of bisphosphonates. Cancer 1997; 80 (Suppl. 8): 1652-60.
16. RALSTON SH, THIEBAUD D, HERRMANN Z et al.: Dose-response study of ibandronate in the treatment of cancer-associated hypercalcaemia. Br J Cancer 1997; 75: 295-300.
17. BODY JJ, MANCINI I: BisphosphonWtes for cancer patients: why, how, and when? Support Care Cancer 2002; 10: 399-407.
18. BOUNAMEAUX HM, SCHIFFERLI J, MONTANI JP et al.: Renal failure associated with intravenous diphosphonates. Lancet 1983; 1: 471.
19. DUMON JC, MAGRITTE A, BODY JJ: Efficacy and safety of the bisphosphonate tiludronate for the treatment of tumor-associated hypercalcemia. Bone Miner 1991; 15: 257-66.
20. O'SULLIVAN TL, AKBARI A, CADNAPAPHORNCHAI P: Acute renal failure associated with the administration of parenteral etidronate. Ren Fail 1994; 16: 767-73.
21. ADAMI S: Ibandronate. Drugs 1999; 57: 109.
22. ADAMI S, ZAMBERLAN N: Diverse effects of bisphosphonates. A comparative review. Drug Saf 1996; 14: 158-70.
23. NANCOLLAS GH, TANG R, PHIPPS RJ et al.: Novel insights into actions with bisphosphonates on bone: Differences in interactions with hydroxyapatite. Bone 2006; 38: 617-27.
24. ADAMI S, FELSENBERG D, CHRISTIANSEN C et al.: Efficacy and safety of ibandronate given by intravenous injection once every 3 months. Bone 2004; 34: 881-9.
25. LIBERMAN UA, WEISS SR, BROLL J et al.: Effect of oral alendronate on bone mineral density and the incidence of fractures in postmenopausal osteoporosis. The Alendronate Phase III Osteoporosis Treatment Study Group. N Engl J Med 1995; 333: 1437-43.
26. RINGE JD, DORST A, FABER H, IBACH K, SORENSON F: Intermittent intravenous ibandronate injections reduce vertebral fracture risk in corticosteroid-induced osteoporosis: Results from a long-term comparative study. Osteoporos Int 2003; 14: 801-7.
27. DELMAS P, ADAMI S, STRUGALA C et al.: Intravenous ibandronate injections in post-menopausal women with osteoporosis. Arthritis Rheum 2006; 54: 1838-46.
28. CORSO A, SERRICCHIO G, ZAPPASODI P et al.: Assessment of renal function in patients with multiple myeloma: The role of urinary proteins. Ann Hematol 1999; 78: 371-5.
29. FLYNN FV: Assessment of Senal function: selected developments. Clin Biochem 1990; 23: 49-54.
30. STEVENS LA, CORESH J, GREENE T, LEVEY AS: Assessing kidney function - measured and estimated glomerular filtration rate. N Engl J Med 2006; 354: 2473-83.
31. BODY JJ: The risk of cumulative renal effects of intravenous bisphosphonates. Support Cancer Ther 2006; 14: 408-18.
32. BODY JJ, PFISTER T, BAUSS F: Preclinical perspectives on bisphosphonate renal safety. Oncologist 2005; 10 (Suppl. 1): 3-7.
33. PFISTER T, ATZPODIEN E, BOHRMANN B: Acute renal effects of intravenous bisphosphonates in the rat. Basic Clin Pharmacol Toxicol 2005; 97: 374-81.
34. PFISTER T, ATZPODIEN E, BAUSS F: The renal effects of minimally nephrotoxic doses of ibandronate and zoledronic acid following single and intermittent intravenous administration in rats. Toxicology 2003; 191: 159-67.
35. GENG Z, MONIER-FAUGERE MC, BAUSS F et al.: Short-term administration of the bisphosphonate ibandronate increases bone volume and prevents hyperparathyroid bone changes in mild experimental renal failure. Clin Nephrol 2000; 54: 45-53.
36. RIZZOLI R, CAVERZASIO J, BAUSS F, BONJOUR JP: Inhibition of bone resorption by the bisphosphonate BM 21.0955 is not associated with an alteration of the renal handling of calcium in rats infused with parathyroid hormone-related protein. Bone 1992; 13: 321-5.
37. NEUGEBAUER G, KÖHLER W, AKINKUNMI L et al.: Influence of peak ibandronic acid concentrations after 6mg iv administration with shortened infusion time (15 and 30 minutes) on renal safety in man. Proc Am Soc Clin Oncol 2001; 20: 122a (Abstract 486).
38. BARRETTAJ, WORTH E, BAUSS F et al.: Ibandronate: a clinical pharmacological and pharmacokinetic update. J Clin Pharmacol 2004; 44: 951-65.
39. NATIONAL KIDNEY FOUNDATION: K/DOQI clinical practice guidelines for chronic kidney disease: Evaluation, classification, and stratification. Am J Kid Dis 2002; 39 (Suppl. 1): S1-266.
40. BONDRONAT European summary of product characteristics: Http://www.emea.eu.int/humandocs/Humans/EPAR/bondronat/bondronat.htm, 2004; accessed March 2007.
41. GROTZ W, NAGEL C, POESCHEL D et al.: Effect of ibandronate on bone loss and renal function after kidney transplantation. J Am Soc Nephrol 2001; 12: 1530-7.
42. RECKER R, STAKKESTAD J, CHESNUT C et al.: Insufficiently dosed intravenous ibandronate injections are associated with suboptimal antifracture efficacy in postmenopausal osteoporosis. Bone 2004; 34: 890-9.
43. THIEBAUD D, BURCKHARDT P, KRIEGBAUM H et al.: Three monthly intravenous injections of ibandronate in the treatment of post-menopausal osteoporosis. Am J Med 1997; 103: 298-307.
44. MILLER PD, WARD P, LEIGH C, BURDESKA A, RECKER RR: Intravenous ibandronate injections and oral ibandronate: Favorable renal tolerability profile in postmenopausal osteoporosis. Arthritis Rheum 2006; 54 (Suppl.): Abstract 1422.
45. BONIVA INJECTION PRESCRIBING INFORMATION: Http://www.rocheusa.com/products/Boniva/InjectionPI.pdf, 2005; accessed March 2007.
46. BLACK DM, DELMAS PD, EASTELL R et al.: Once-yearly zoledronic acid for treatment of postmenopausal osteoporosis. N Engl J Med 2007; 356: 1809-22.
47. VON TIRPITZ C, KLAUS J, STEINKAMP M et al.: Therapy of osteoporosis in patients with Crohn's disease: A randomized study comparing sodium fluoride and ibandronate. Aliment Pharmacol Ther 2003; 17: 807-16.
48. DIEL I, BODY J, BERGSTRÖM B: Renal safety of intravenous ibandronate for up to 4 years of treatment in patients with metastatic bone disease. Ann Oncol 2004; 15 (Suppl. 3): Iii224.
49. PECHERSTORFER M, LUDWIG H, SCHLOSSER K et al.: Administration of the bisphosphonate ibandronate (BM 21.0955) by intravenous bolos injection. J Bone Miner Res 1996; 11: 587-93.
50. STAKKESTAD JA, BENEVOLENSKAYA LI, STEPAN JJ et al.: Intravenous ibandronate injections given every three months: A new treatment option to prevent bone loss in post-menopausal women. Ann Rheum Dis 2003; 62: 969-75.
51. MILLER PD: Should bisphosphonates be given to patients with end-stage renal disease? Semin Dial. In press.