Oral ibandronate: a less frequently administered therapeutic option for postmenopausal osteoporosis

[en] Osteoporosis is a severe condition, associated with significant disability as a result of fragility fractures and increased mortality. Oral bisphosphonates effectively reduce the risk of osteoporotic fracture and are generally well tolerated. Unfortunately, patient outcomes are often compromised by suboptimal therapeutic adherence. In other disease areas, reduced dosing frequency has been shown to improve therapeutic adherence. A positive impact for adherence has been observed with a reduction in the bisphosphonate dosing frequency from daily to weekly. However, overall adherence remains suboptimal. lbandronate is a potent nitrogen-containing bisphosphonate specifically designed for less frequent than weekly administration, without compromise for efficacy or tolerability. This article reviews the pharmacology, efficacy and tolerability of oral ibandronate when administered with extended dosing intervals in postmenopausal osteoporosis.

Disciplines :

General & internal medicine

Author, co-author :

Reginster, Jean-Yves ; Université de Liège - ULiège > Département des sciences de la santé publique > Epidémiologie et santé publique

Language :

English

Title :

Oral ibandronate: a less frequently administered therapeutic option for postmenopausal osteoporosis

Publication date :

October 2005

Journal title :

Expert Opinion on Pharmacotherapy

ISSN :

1465-6566

eISSN :

1744-7666

Publisher :

Ashley Publications Ltd, London, United Kingdom

Volume :

Issue :

Pages :

2301-2313

Peer reviewed :

Peer Reviewed verified by ORBi

Available on ORBi :

since 27 August 2009

Statistics

Number of views

28 (1 by ULiège)

Number of downloads

1 (1 by ULiège)

More statistics

Scopus citations^®

Scopus citations^®
without self-citations

OpenCitations

Bibliography

CHRISCHILLES EA, BUTLER CD, DAVIS CS, WALLACE RB: A model of lifetime osteoporosis impact. Arch. Intern. Med. (1991) 151(10):2026-2032.
GREENDALE GA, BARRETT-CONNOR E, INGLES S, HAILE R: Late physical and functional effects of osteoporotic fracture in women: the Rancho Bernardo Study. J. Am. Geriatr. Soc. (1995) 43(9):955-961.
COOPER C, ATKINSON EJ, JACOBSEN SJ, O'FALLON WM, MELTON LJ 3rd: Population-based study of survival after osteoporotic fractures. Am. J. Epidemiol. (1993) 137(9):1001-1005.
MELTON LJ 3rd: Adverse outcomes of osteoporotic fractures in the general population. J. Bone Miner. Res. (2003) 18(6):1139-1141.
IOF: Osteoporosis in the European Community: A call to action. (2001):37.
RAY NF, CHAN JK, THAMER M, MELTON LJ 3rd: Medical expenditures for the treatment of osteoporotic fractures in the United States in 1995: report from the National Osteoporosis Foundation. J. Bone Miner. Res. (1997) 12(1):24-35.
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(9041):1535-1541.
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(1):83-91.
MCCLUNG MR, GEUSENS P, MILLER PD et al.: Effect of risedronate on the risk of hip fracture in elderly women. Hip Intervention Program Study Group. N. Engl. J. Med. (2001) 344(5):333-340.
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(14):1344-1352.
CHESNUT CH 3rd, 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(8):1241-1249.
CUMMINGS SR, BLACK DM, THOMPSON DE et al.: Effect of alendronate on risk of fracture in women with low bone density but without vertebral fractures: results from the Fracture Intervention Trial. JAMA (1998) 280(24):2077-2082.
DELMAS PD, RECKER RR, CHESNUT CH 3rd et al.: Daily and intermittent oral ibandronate normalize bone turnover and provide significant reduction in vertebral fracture risk: results from the BONE study. Osteoporos. Int. (2004) 15(10):792-798.
SAMBROOK P, RODRIGUEZ J, WASNICH R et al.: Alendronate in the prevention of osteoporosis: 7-year follow-up. Osteoporos. Int. (2004) 15(6):483-488.
SORENSEN O, CRAWFORD G, MULDER H et al.: Long-term efficacy of risedronate: a 5-year placebo-controlled clinical experience. Bone (2003) 32(2):120-126.
BONE HG, HOSKING D, DEVOGELAER JP et al.: Ten years' experience with alendronate for osteoporosis in postmenopausal women. N. Engl. J. Med. (2004) 350(12):1189-1199.
RECKER RR, GALLAGHER R, MACCOSBE PE: Impact of dosing frequency on bisphosphonate medication adherence in a large, longitudinal cohort of women. Mayo Clin. Proc. (2005) 80(7):856-861.
PAPAIOANNOU A, IOANNIDIS G, ADACHI JD et al.: Adherence to bisphosphonates and hormone replacement therapy in a tertiary care setting of patients in the CANDOO database. Osteoporos. Int. (2003) 14(10):808-813.
SUNYECZ JA, GALLAGHER R, MACCOSBE PE: Persistence with medication in women taking daily versus weekly bisphosphonates for osteoporosis. Female Patient (2005). In press.
YOOD RA, EMANI S, REED JI et al.: Compliance with pharmacologic therapy for osteoporosis. Osteoporos. Int. (2003) 14(12):965-968.
CARO JJ, ISHAK KJ, HUYBRECHTS KF, RAGGIO G, NAUJOKS C: The impact of compliance with osteoporosis therapy on fracture rates in actual practice. Osteoporos. Int. (2004) 15(12):1003-1008.
MCCOMBS JS, THIEBAUD P, MCLAUGHLIN-MILEY C, SHI J: Compliance with drug therapies for the treatment and prevention of osteoporosis. Maturitas. (2004) 48(3):271-287.
LOMBAS C, HAKIM C, ZANCHETTA JR: Compliance with alendronate treatment in an osteoporosis clinic. J. Bone Miner. Res. (2001) 15(Suppl. 1):S529 (Abstract M406).
PENNING-VAN BEEST F, GOETTSCH W, ERKENS J, HERINGS R: Persistence with bisphosphonate therapy among postmenopausal osteoporotic women and the impact of dosing frequency. Value Health (2004) 7:724 (Abstract POS728).
ETTINGER M, GALLAGHER R, AMONKAR M, SMITH J, MACCOSBE P: Medication persistence is improved with less frequent dosing of bisphosphonates, but remains inadequate. Arthritis Rheum. (2004) 15(Suppl.):S513 (Abstract 1325).
BARTL R, GOETTE S, HADJI P, HAMMERSCHMIDT T: Persistence and compliance with daily and weekly-administered bisphosphonates for osteoporosis treatment in Germany. Osteoporos. Int. (2005) 16(Suppl. 3):S45 (Abstract P195).
EASTELL R, GARNERO P, VRIJENS B et al.: Influence of patient compliance with risedronate therapy on bone turnover marker and bone mineral density response: The IMPACT study. Calcif. Tissue Int. (2003) 72:408 (Abstract P-297).
SEBALDT R, SHANE L, PHAM B, COOK R et al.: Longer-term effectiveness outcomes of non-compliance and non-persistence with daily-regimen bisphosphonate therapy in patients with osteoporosis treated in tertiary specialist care. Osteoporos. Int. (2004) 15(Suppl. 1):S107 (Abstract P391SA).
HARRIS S, SIRIS E, ABBOTT T, BARR CE: Reduced osteoporotic fracture risk in patients adherence to bisphosphonate therapy. Program & Abstracts of The Endocrine Society's 87th Annual Meeting, San Diego, CA, USA (2005):P3-P382.
VENTURINI F, NICHOL MB, SUNG JC et al.: Compliance with sulfonylureas in a health maintenance organization: a pharmacy record-based study. Ann. Pharmacother. (1999) 33(3):281-288.
CLAXTON AJ, CRAMER J, PIERCE C: A systematic review of the associations between dose regimens and medication compliance. Clin. Ther. (2001) 23(8):1296-1310.
THIEBAUD D, BURCKHARDT P, MELCHIOR J et al.: Two years' effectiveness of intravenous pamidronate (APD) versus oral fluoride for osteoporosis occurring in the postmenopause. Osteoporos. Int. (1994) 4(2):76-83.
MORABITO N, GAUDIO A, LASCO A et al.: Three-year effectiveness of intravenous pamidronate versus pamidronate plus slow-release sodium fluoride for postmenopausal osteoporosis. Osteoporos. Int. (2003) 14(6):500-506.
CAUZA E, ETEMAD M, WINKLER F et al.: Pamidronate increases bone mineral density in women with postmenopausal or steroid-induced osteoporosis. J. Clin. Pharm. Ther. (2004) 29(5):431-436.
CHAN SS, NERY LM, MCELDUFF A et al.: Intravenous pamidronate in the treatment and prevention of osteoporosis. Intern. Med. J. (2004) 34(4):162-166.
REID IR, BROWN JP, BURCKHARDT P et al.: (2002) Intravenous zoledronic acid in postmenopausal women with low bone mineral density. N. Engl. J. Med. (2002) 346(9):653-661.
ADAMI S, FELSENBERG D, CHRISTIANSEN C et al.: Efficacy and safety of ibandronate given by intravenous injection once every 3 months. Bone (2004) 34(5):881-889.
STAKKESTAD JA, BENEVOLENSKAYA LI, STEPAN JJ et al.: Intravenous ibandronate injections given every three months: a new treatment option to prevent bone loss in postmenopausal women. Ann. Rheum. Dis. (2003) 62(10):969-975.
SIMON JA, LEWIECKI EM, SMITH ME et al.: Patient preference for once-weekly alendronate 70mg versus once-daily alendronate 10mg: a muticenter, randomized, open-label, cross-over study. Clin. Ther. (2002) 24(11):1871-1886.
KENDLER D, KUNG AW, FULEIHAN GEL H et al.: Patients with osteoporosis prefer once weekly to once daily dosing with alendronate. Maturitas (2004) 48(3):243-251.
SIMON JA, BEUSTERIEN KM, LEIDY NK, HEBBORN A: Women with postmenopausal osteoporosis express a preference for once-monthly versus once-weekly bisphosphonate treatment. Female Patient (2005) 30:31-36.
BAUSS F, RUSSELL RG: Ibandronate in osteoporosis: preclinical data and rationale for intermittent dosing. Osteoporos. Int. (2004) 15(6):423-433.
MUHLBAUER RC, BAUSS F, SCHENK R et al.: BM 21.0955, a potent new bisphosphonate to inhibit bone resorption. J. Bone Miner. Res. (1991) 6(9):1003-1011.
HYLDSTRUP L, FLESCH G, HAUFFE SA: Pharmacokinetic evaluation of pamidronate after oral administration: a study on dose proportionality, absolute bioavailability, and effect of repeated administration. Calcif. Tissue Int. (1993) 53(5):297-300.
GERTZ BJ, HOLLAND SD, KLINE WF et al.: Studies of the oral bioavailability of alendronate. Clin. Pharmacol. Ther. (1995) 58(3):288-298.
MITCHELL DY, BARR WH, EUSEBIO RA et al.: Risedronate pharmacokinetics and intra- and inter-subject variability upon single-dose intravenous and oral administration. Pharm. Res. (2001) 18(2):166-170.
BARRETT J, WORTH E, BAUSS F, EPSTEIN S: Ibandronate: a clinical pharmacological and pharmacokinetic update. J. Clin. Pharmacol. (2004) 44(9):951-965.
BAUSS F, ENDELE R, BESENFELDER E, HOELCK JP: Ibandronate: serum kinetics, tissue distribution and binding to bone following intravenous bolus injection. Calcif. Tissue Int. (2002) 70:289-290 (Abstract P-128).
LIN JH, DUGGAN DE, CHEN IW, ELLSWORTH RL: Physiological disposition of alendronate, a potent antiosteolytic bisphosphonate, in laboratory animals. Drug Metab. Dispos. (1991) 19(5):926-932.
ENDELE R, LOEW H, BAUSS F: Analytical methods for the quantification of ibandronate in body fluids and bone. J. Pharm. Biomed. Anal. (2005) 39:246-56.
BAUSS F, LALLA S, ENDELE R, HOTHORN LA: Effects of treatment with ibandronate on bone mass, architecture, biomechanical properties, and bone concentration of ibandronate in ovariectomized aged rats. J. Rheumatol. (2002) 29(10):2200-2208.
BAUSS F, KLING L, WORTH E, BARRETT J: Drug-drug interactions are unlikely with ibandronate. Osteoporos. Int. (2004) 15(Suppl. 1):S101 (Abstract P374SU).
BAUSS F, WAGNER M, HOTHORN LH: Total administered dose of ibandronate determines its effects on bone mass and architecture in ovariectomized aged rats. J. Rheumatol. (2002) 29(5):990-998.
MONIER-FAUGERE MC, FRIEDLER RM, BAUSS F, MALLUCHE HH: A new bisphosphonate, BM 21.0955, prevents bone loss associated with cessation of ovarian function in experimental dogs. J. Bone Miner. Res. (1993) 8(11):1345-1355.
MONIER-FAUGERE MC, GENG Z, PASCHALIS EP et al.: Intermittent and continuous administration of the bisphosphonate ibandronate in ovariohysterectomized beagle dogs: effects on bone morphometry and mineral properties. J. Bone Miner. Res. (1999) 14(10):1768-1778.
SMITH SY, RECKER RR, HANNAN M, MULLER R, BAUSS F: Intermittent intravenous administration of the bisphosphonate ibandronate prevents bone loss and maintains bone strength and quality in ovariectomized cynomolgus monkeys. Bone (2003) 32(1):45-55.
LALLA S, HOTHORN LA, HAAG N, BADER R, BAUSS F: Lifelong administration of high doses of ibandronate increases bone mass and maintains bone quality of lumbar vertebrae in rats. Osteoporos. Int. (1998) 8(2):97-103.
SMITH SY, RECKER R, HANNAN M, BAUSS F: Effects of ibandronate treatment on bone mass, architecture and strength in the ovariectomized cynomolgus monkey. J. Bone Miner. Res. (1999) 14(Suppl. 1):402 (Abstract A370).
MÜLLER R, HANNAN M, SMITH S, BAUSS F: Intermittent ibandronate preserves bone quality and bone strength in the lumbar spine after 16 months of treatment in the ovariectomized cynomolgus monkey. J. Bone Miner. Res. (2004) 19(11):1787-1796.
BAUSS F, SCHENK RK, HORT S, MULLER-BECKMANN B, SPONER G: New model for simulation of fracture repair in full-grown beagle dogs: model characterization and results from a long-term study with ibandronate. J. Pharmacol. Toxicol. Methods. (2004) 50(1):25-34.
RAVN P, CLEMMESEN B, RIIS BJ, CHRISTIANSEN C: The effect on bone mass and bone markers of different doses of ibandronate: a new bisphosphonate for prevention and treatment of postmenopausal osteoporosis: a 1-year, randomized, double-blind, placebo-controlled dose-finding study. Bone (1996) 19(5):527-533.
SCHIMMER RC, BAUSS F: Effect of daily and intermittent use of ibandronate on bone mass and bone turnover in postmenopausal osteoporosis: a review of three Phase II studies. Clin. Ther. (2003) 25(1):19-34.
RIIS BJ, ISE J, VON STEIN T, BAGGER Y, CHRISTIANSEN C: Ibandronate: a comparison of oral daily dosing versus intermittent dosing in postmenopausal osteoporosis. J. Bone Miner. Res. (2001) 16(10):1871-1878.
GENANT HK, WU CY, VAN KUIJ KC, NEVITT MC: Vertebral fracture assessment using a semiquantitative technique. J. Bone Miner. Res. (1993) 8(9):1137-1148.
GENANT HK, JERGAS M, PALERMO L et al.: Comparison of semiquantitative visual and quantitative morphometric assessment of prevalent and incident vertebral fractures in osteoporosis. J. Bone Miner. Res. (1996) 11(7):984-996.
FELSENBERG D, PAPAPOULOS SE, MILLER PD, HUGHES C, SCHIMMER RC: Oral daily ibandronate rapidly and significantly reduces the risk of vertebral fractures of greater severity after 1, 2 and 3 years in postmenopausal women with osteoporosis. Bone. (2005) (In press).
MARCUS R, WONG M, HEATH H 3rd, STOCK JL: Antiresorptive treatment of postmenopausal osteoporosis: comparison of study designs and outcomes in large clinical trials with fracture as an endpoint. Endocr. Rev. (2002) 23(1):16-37.
BLACK DM, THOMPSON DE, BAUER DC et al.: Fracture risk reduction with alendronate in women with osteoporosis: the Fracture Intervention Trial. FIT Research Group. J. Clin. Endocrinol. Metab. (2000) 85(11):4118-4124.
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(22):1437-1443.
POLS HA, FELSENBERG D, HANLEY DA et al.: Multinational, placebo-controlled, randomized trial of the effects of alendronate on bone density and fracture risk in postmenopausal women with low bone mass: results of the FOSIT study. Foxamax International Trial Study Group. Osteoporos. Int. (1999) 9(5):461-468.
REGINSTER J-Y, WILSON K, DUMONT E, BONVOISIN B, BARRETT J: Monthly oral ibandronate is well tolerated and efficacious in postmenopausal women: results from the Monthly Oral Pilot Study. J. Clin. Endocrinol. Metab. (2005) (In press).
BROWN JP, KENDLER DL, MCCLUNG MR et al.: The efficacy and tolerability of risedronate once a week for the treatment of postmenopausal osteoporosis. Calcif. Tissue Int. (2002) 71(2):103-111.
SCHNITZER T, BONE HG, CREPALDI G et al.: Therapeutic equivalence of alendronate 70 mg once-weekly and alendronate 10 mg daily in the treatment of osteoporosis. Alendronate Once-Weekly Study Group. Aging (Milano) (2000) 12(1):1-12.
EASTELL R, BARTON I, HANNON RA et al. Relationship of early changes in bone resorption to the reduction in fracture risk with risedronate. J. Bone Miner. Res. (2003) 18(6):1051-1056.
HOCHBERG MC, GREENSPAN S, WASNICH RD et al.: (2002) Changes in bone density and turnover explain the reductions in incidence of nonvertebral fractures that occur during treatment with antiresorptive agents. J. Clin. Endocrinol. Metab. (2002) 87(4):1586-1592.
WASNICH RD, MILLER PD: Antifracture efficacy of antiresorptive agents are related to changes in bone density. J. Clin. Endocrinol. Metab. (2000) 85(1):231-236.
MILLER PD, MCCLUNG M, MACOVEI L et al.: Monthly oral ibandronate therapy in postmenopausal osteoporosis: one-year results from the MOBILE study. J. Bone Miner. Res. (2005) 20:1315-1322.
ICH HARMONISED TRIPARTITE GUIDELINE: Statistical principles for clinical trials. Statist. Med. (1999) 18:1905-1942.
MCCLUNG MR, WASNICH RD, RECKER R et al.: Oral daily ibandronate prevents bone loss in early postmenopausal women with osteoporosis. J. Bone Miner. Res. (2004) 19(1):11-18.
DE GROEN PC, LUBBE DF, HIRSCH LJ et al.: Esophagitis associated with the use of alendronate. N. Engl. J. Med. (1996) 335(14):1016-1021.
ETTINGER B, PRESSMAN A, SCHEIN J: Clinic visits and hospital admissions for care of acid-related upper gastrointestinal disorders in women using alendronate for osteoporosis. Am. J. Manag. Care. (1998) 4(10):1377-1382.
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) 4:488-492.
LANZA FL, HUNT RH, THOMSON AB, PROVENZA JM, BLANK MA: Endoscopic comparison of esophageal and gastroduodenal effects of risedronate and alendronate in postmenopausal women. Gastroenterology (2000) 119(3):631-638.
TOSTESON AN, GROVE MR, HAMMOND CS et al.: Early discontinuation of treatment for osteoporosis. Am. J. Med. (2003) 115(3):209-216.
HAMILTON B, MCCOY K, TAGGART H: Tolerability and compliance with risedronate in clinical practice. Osteoporos. Int. (2003) 14(3):259-262.
ROSEN C, DELMAS P, EMKEY R et al.: Favorable upper gastrointestinal safety profile of ibandronate in patients with a history of gastrointestinal disorders or receiving concomitant NSAIDs. Arthritis Rheum. (2003) 48(Suppl. 9):Abstract 102.
ETTINGER M, FELSENBERG D, HARRIS S et al.: The safety and tolerability of oral daily and intermittent ibandronate are not influenced by age. J. Rheumatol. (2005) (In press).
RECKER RR, WEINSTEIN RS, CHESNUT CH et al.: Histomorphometric evaluation of daily and intermittent oral ibandronate in women with postmenopausal osteoporosis: results from the BONE study. Osteoporos. Int. (2004) 15:231-237.