Once-monthly oral ibandronate in postmenopausal osteoporosis: Translation and updated review

Clinical Therapeutics

Volumn 31, Issue 7, 2009, Pages 1497-1510

  Rossini, Maurizio ^a   Viapiana, Ombretta ^a   Gatti, Davide ^a   Adami, Silvano ^a  

^a UNIVERSITY HOSPITAL OF VERONA   (Italy)

Author keywords

adherence; bisphosphonates; ibandronate; osteoporosis

Indexed keywords

ALENDRONIC ACID; CALCIUM; IBANDRONIC ACID; PLACEBO; RISEDRONIC ACID; VITAMIN D;

BONE DENSITY; BONE TURNOVER; CLINICAL TRIAL; DOSAGE SCHEDULE COMPARISON; DOSE RESPONSE; DRUG DOSE COMPARISON; DRUG DOSE INCREASE; DRUG EFFICACY; DRUG INTERMITTENT THERAPY; DRUG TOLERABILITY; DRUG WITHDRAWAL; FRAGILITY FRACTURE; HIP FRACTURE; HUMAN; PATIENT COMPLIANCE; POSTMENOPAUSE OSTEOPOROSIS; REVIEW; RISK REDUCTION; VERTEBRA FRACTURE;

ADMINISTRATION, ORAL; BONE DENSITY CONSERVATION AGENTS; DIPHOSPHONATES; DRUG ADMINISTRATION SCHEDULE; FEMALE; HUMANS; MEDICATION ADHERENCE; OSTEOPOROSIS, POSTMENOPAUSAL;

EID: 68649102571     PISSN: 01492918     EISSN: 1879114X     Source Type: Journal    
DOI: 10.1016/j.clinthera.2009.07.018     Document Type: Review

References (66)

1. Sambrook P., and Cooper C. Osteoporosis [published correction appears in Lancet. 2006;368:28]. Lancet 367 (2006) 2010-2018
2. Cole Z., Dennison E., and Cooper C. Update on the treatment of post-menopausal osteoporosis. Br Med Bull. 86 (2008) 129-143
3. Cummings S.R., Black D.M., Thompson D.E., 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 280 (1998) 2077-2082
4. Liberman U.A., Weiss S.R., Bröll J., et al., the Alendronate Phase III Osteoporosis Treatment Study Group. Effect of oral alendronate on bone mineral density and the incidence of fractures in postmenopausal osteoporosis. N Engl J Med. 333 (1995) 1437-1443
5. Center J.R., Nguyen T.V., Schneider D., et al. Mortality after all major types of osteoporotic fracture in men and women: An observational study. Lancet 353 (1999) 878-882
6. Cramer J., Amonkar M.M., Hebborn A., and Altman R. Compliance and persistence with bisphosphonate dosing regimens among women with postmenopausal osteoporosis. Curr Med Res Opin. 21 (2005) 1453-1460
7. Recker R.R., Gallagher R., and MacCosbe P.E. Effect of dosing frequency on bisphosphonate medication adherence in a large longitudinal cohort of women. Mayo Clin Proc. 80 (2005) 856-861
8. 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. 72 (2003) 297
9. Sebaldt O.I., Shane L.G., Pham B., et al. Longer term effectiveness outcomes of noncompliance and nonpersistence with daily regimen bisphosphonates therapy in patients with osteoporosis treated in tertiary specialist care. Osteoporos Int. 15 Suppl 1 (2004) S107
10. Yood R.A., Emani S., Reed J.I., et al. Compliance with pharmacologic therapy for osteoporosis. Osteoporos Int. 14 (2003) 965-968
11. Caro J.J., Ishak K.J., Huybrechts K.F., et al. The impact of compliance with osteoporosis therapy on fracture rates in actual practice. Osteoporos Int. 15 (2004) 1003-1008
12. Silverman S., Siris E., Abbott T., et al. Adherence to bis-phosphonate therapy is associated with decreased non-vertebral osteoporotic fracture risk. J Bone Miner Res. 20 Suppl 1 (2005) SU417
13. Adami S., Isaia G., Luisetto G., et al., the ICARO Study Group. Fracture incidence and characterization in patients on osteoporosis treatment: The ICARO study. J Bone Miner Res. 21 (2006) 1565-1570
14. McCombs J.S., Thiebaud P., McLaughlin-Miley C., and Shi J. Compliance with drug therapies for the treatment and prevention of osteoporosis. Maturitas 48 (2004) 271-287
15. Caro J.J., Ishak K.J., Huybrechts K.F., et al. Clinical and economic impact of adherence to osteoporosis medication. Osteoporos Int. 14 Suppl 7 (2003) PL6
16. Rawson N.S. "Effectiveness" in the evaluation of new drugs: A misunderstood concept?. Can J Clin Pharmacol. 8 (2001) 61-62
17. Revicki D.A., and Frank L. Pharmacoeconomic evaluation in the real world. Effectiveness versus efficacy studies. PharmacoEconomics 15 (1999) 423-434
18. Reginster J.Y., and Rebenda V. Patient preference in the management of postmenopausal osteoporosis with bisphosphonates. Clin Interv Aging. 1 (2006) 415-423
19. Rossini M., Bianchi G., Di Munno O., et al., the Treatment of Osteoporosis in clinical Practice (TOP) Study Group. Determinants of adherence to osteoporosis treatment in clinical practice. Osteoporos Int. 17 (2006) 914-921
20. Tosteson A.N., Grove M.R., Hammond C.S., et al. Early discontinuation of treatment for osteoporosis. Am J Med. 115 (2003) 209-216
21. Ettinger B., Pressman A., and 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 4 (1998) 1377-1382
22. Hamilton B., McCoy K., and Taggart H. Tolerability and compliance with risedronate in clinical practice. Osteoporos Int. 14 (2003) 259-262
23. Segal E., Tamir A., and Ish-Shalom S. Compliance of osteoporotic patients with different treatment regimens. Isr Med Assoc J. 5 (2003) 859-862
24. Turbi C., Herrero-Beaumont G., Acebes J.C., et al. Compliance and satisfaction with raloxifene versus alen-dronate for the treatment of postmenopausal osteoporosis in clinical practice: An open-label, prospective, nonrandomized, observational study. Clin Ther. 26 (2004) 245-256
25. Silverman S.L., Cramer J.A., Sunyecz, et al. Women are more persistent with monthly bisphosphonate therapy compared to weekly bisphosphonates: 12-Month results from 2 retrospective databases. J Bone Miner Res. 22 Suppl 1 (2007) S454
26. Lewiecki E.M., Babbit A.M., Piziak V.K., et al. Adherence to and gastrointestinal tolerability of monthly oral or quarterly intravenous ibandronate therapy in women with previous intolerance to oral bisphosphonates: A 12-month, open-label, prospective evaluation. Clin Ther. 30 (2008) 605-621
27. Adami S., and Zamberlan N. Adverse effects of bisphosphonates. A comparative review. Drug Saf. 14 (1996) 158-170
28. Peter C.P., Handt L.K., and Smith S.M. Esophageal irritation due to alen-dronate sodium tablets: Possible mechanisms. Dig Dis Sci. 43 (1998) 1998-2002
29. Grauer A., Knaus, Sievel M.J., et al. Treatment of Paget's disease of bone with the new bisphosphonate BM21.0955 by intravenous bolus injection. J Bone Miner Res. 9 Suppl 1 (1994) S430
30. Pecherstorfer M., Hermann Z., Body J.J., et al. Randomized phase II trial comparing different doses of the bisphosphonate ibandronate in the treatment of hypercalcemia of malignancy. J Clin Oncol. 14 (1996) 268-276
31. Ravn P., Clemmesen B., Riis B.J., and 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 19 (1996) 527-533
32. Mühlbauer R.C., Bauss F., Schenk R., et al. BM 21.0955, a potent new bisphosphonate to inhibit bone resorption. J Bone Miner Res. 6 (1991) 1003-1011
33. Nancollas G.H., Tang R., Phipps R.J., et al. Novel insights into actions of bisphosphonates on bone: Differences in interactions with hydroxy-apatite. Bone 38 (2006) 617-627
34. Monier-Faugere M.C., Geng Z., Paschalis E.P., 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. 14 (1999) 1768-1778
35. Müller R., Hannan M., Smith S.Y., and 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. 19 (2004) 1787-1796
36. Smith S.Y., Recker R.R., Hannan M., et al. Intermittent intravenous administration of the bisphosphonate ibandronate prevents bone loss and maintains bone strength and quality in ovariectomized cynomolgus monkeys. Bone 32 (2003) 45-55
37. Rossini M., Viapiana O., Idolazzi L., and Fracassi E. Ibandronate: A new approach in the treatment of post-menopausal osteoporosis [in Italian]. Bisfosfonati. 7 (2006) 3-19
38. Riis B.J., Ise J., von Stein T., et al. Iban-dronate: A comparison of oral daily dosing versus intermittent dosing in postmenopausal osteoporosis. J Bone Miner Res. 16 (2001) 1871-1878
39. Harris S.T., Watts N.B., Genant H.K., et al., the Vertebral Efficacy With Risedronate Therapy (VERT) Study Group. Effects of risedronate treatment on vertebral and nonvertebral fractures in women with postmenopausal osteoporosis: A randomized controlled trial. JAMA 282 (1999) 1344-1352
40. Reid D.M., Hosking D., Kendler D., et al. A comparison of the effect of alendronate and risedronate on bone mineral density in postmenopausal women with osteoporosis: 24-Month results from FACTS-International. Int J Clin Pract. 62 (2008) 575-584
41. Chesnut C.H., Skag A., Christiansen C., et al., the Oral Ibandronate Osteoporosis Vertebral Fracture Trial in North America and Europe (BONE) Investigators. Effects of oral ibandronate administered daily or intermittently on fracture risk in post-menopausal osteoporosis: The BONE trial. J Bone Miner Res. 19 (2004) 1241-1249
42. Felsenberg D., Miller P., Armbrecht G., et al. Oral ibandronate significantly reduces the risk of vertebral fractures of greater severity after 1, 2, and 3 years in postmenopausal women with osteoporosis. Bone 37 (2005) 651-654
43. Black D.M., Thompson D.E., Bauer D.C., et al., the FIT Research Group. Fracture risk reduction with alendronate in women with osteoporosis: The Fracture Intervention Trial [published correction appears in J Clin Endocrinol Metab. 2001;86:938]. J Clin Endocrinol Metab. 85 (2000) 4118-4124
44. McClung M.R., Geusens P., Miller P.D., et al., the Hip Intervention Program Study Group. Effect of rised-ronate on the risk of hip fracture in elderly women. N Engl J Med. 344 (2001) 333-340
45. Papapoulos S.E., and Schimmer R.C. Changes in bone remodelling and antifracture efficacy of intermittent bisphosphonate therapy: Implications from clinical studies with iban-dronate. Ann Rheum Dis. 66 (2007) 853-858
46. Schnitzer T., Bone H.G., Crepaldi G., et al., the Alendronate Once-Weekly Study Group. Therapeutic equivalence of alendronate 70 mg once-weekly and alendronate 10 mg daily in the treatment of osteoporosis. Aging (Milano) 12 (2000) 1-12
47. Brown J.P., Kendler D.L., McClung M.R., et al. The efficacy and tolerability of risedronate once a week for the treatment of postmenopausal osteoporosis. Calcif Tissue Int. 71 (2002) 103-111
48. Reginster J.Y., Wilson K.M., Dumont E., et al. Monthly oral ibandronate is well tolerated and efficacious in postmenopausal women: Results from the monthly oral pilot study. J Clin Endocrinol Metab. 90 (2005) 5018-5024
49. Delmas P.D., Recker R.R., Chesnut III C.H., 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. 15 (2004) 792-798
50. Miller P.D., McClung M.R., Macovei L., et al. Monthly oral ibandronate therapy in postmenopausal osteoporosis: 1-Year results from the MOBILE study. J Bone Miner Res. 20 (2005) 1315-1322
51. Reginster J.Y., Adami S., Lakatos P., et al. Efficacy and tolerability of once-monthly oral ibandronate in post-menopausal osteoporosis: 2 Year results from the MOBILE study [published correction appears in Ann Rheum Dis. 2008;67:280]. Ann Rheum Dis. 65 (2006) 654-661
52. Delmas P.D., Adami S., Strugala C., et al. Intravenous ibandronate injections in postmenopausal osteoporosis: One-year results from the dosing intravenous administration study. Arthritis Rheum. 54 (2006) 1838-1846
53. Cranney A., Wells G.A., Yetisir E., et al. Ibandronate for the prevention of nonvertebral fractures: A pooled analysis of individual patient data. Osteoporos Int. 20 (2009) 291-297
54. Wasnich R.D., and Miller P.D. Antifracture efficacy of antiresorptive agents are related to changes in bone density. J Clin Endocrinol Metab. 85 (2000) 231-236
55. Cummings S.R., Karpf D.B., Harris F., et al. Improvement in spine bone density and reduction in risk of vertebral fractures during treatment with antiresorptive drugs. Am J Med. 112 (2002) 281-289
56. Hochberg M.C., Greenspan S., Wasnich R.D., et al. Changes in bone density and turnover explain the reductions in incidence of nonverte-bral fractures that occur during treatment with antiresorptive agents. J Clin Endocrinol Metab. 87 (2002) 1586-1592
57. Sarkar S., Mitlak B.H., Wong M., et al. Relationships between bone mineral density and incident vertebral fracture risk with raloxifene therapy. J Bone Miner Res. 17 (2002) 1-10
58. Watts N.B., Geusens P., Barton I.P., and Felsenberg D. Relationship between changes in BMD and nonvertebral fracture incidence associated with risedronate: Reduction in risk of nonvertebral fracture is not related to change in BMD. J Bone Miner Res. 20 (2005) 2097-2104
59. Delmas P.D., and Seeman E. Changes in bone mineral density explain little of the reduction in vertebral or non-vertebral fracture risk with anti-resorptive therapy. Bone 34 (2004) 599-604
60. Kaptoge S., Benevolenskaya L.I., Bhalla A.K., et al. Low BMD is less predictive than reported falls for future limb fractures in women across Europe: Results from the European Prospective Osteoporosis Study. Bone 36 (2005) 387-398
61. Gatti D., and Adami S. Bone mineral density and risk of fracture in clinical trials [in Italian]. Bisfosfonati. 1 (2004) 3-10
62. Adami S., and Viapiana O. Ibandronate: New options in the treatment of osteoporosis. Drugs Today (Barc) 39 (2003) 877-886
63. Bjarnason N.H., Sarkar S., Duong T., et al. Six and twelve month changes in bone turnover are related to reduction in vertebral fracture risk during 3 years of raloxifene treatment in postmenopausal osteoporosis. Osteoporos Int. 12 (2001) 922-930
64. Eastell R., Barton I., Hannon R.A., et al. Relationship of early changes in bone resorption to the reduction in fracture risk with risedronate. J Bone Miner Res. 18 (2003) 1051-1056
65. Cummings S.R., Karpf D.B., Harris F., et al. Improvement in spine bone density and reduction in risk of vertebral fractures during treatment with antiresorptive drugs. Am J Med. 112 (2002) 281-289
66. Miller P.D., Epstein S., Sedarati F., and Reginster J.Y. Once-monthly oral ibandronate compared with weekly oral alendronate in postmenopausal osteoporosis: Results from the head-to-head MOTION study. Curr Med Res Opin. 24 (2008) 207-213