Quarterly intravenous ibandronate for postmenopausal osteoporosis

Women's Health

Volumn 4, Issue 3, 2008, Pages 219-228

  Emkey, Ronald D ^a  

^a Emkey Arthritis and Osteoporosis   (United States)

Author keywords

Annual cumulative exposure; Bone mineral density; Bone turnover markets; Extended dosing intervals; Ibandronate; Nitrogen containing bisphosphonates; Parenteral postmenopausal osteoporosis

Indexed keywords

ALENDRONIC ACID; ALKALINE PHOSPHATASE BONE ISOENZYME; AMINO TERMINAL TELOPEPTIDE; ANTIPYRETIC AGENT; BIOLOGICAL MARKER; BISPHOSPHONIC ACID DERIVATIVE; CREATININE; FARNESYL DIPHOSPHATE; IBANDRONIC ACID; OSTEOCALCIN; PAMIDRONIC ACID; PLACEBO; RISEDRONIC ACID; ZOLEDRONIC ACID;

ARTHRALGIA; BONE DENSITY; BONE METASTASIS; BONE NECROSIS; CLINICAL TRIAL; COMBINATION CHEMOTHERAPY; CREATININE BLOOD LEVEL; DOSAGE SCHEDULE COMPARISON; DOSE RESPONSE; DRUG APPROVAL; DRUG BLOOD LEVEL; DRUG DOSAGE FORM COMPARISON; DRUG DOSE COMPARISON; DRUG DOSE INCREASE; DRUG DOSE REGIMEN; DRUG EFFICACY; DRUG ELIMINATION; DRUG HALF LIFE; DRUG INDUCED HEADACHE; DRUG INHIBITION; DRUG INTERMITTENT THERAPY; DRUG SAFETY; DRUG STRUCTURE; DRUG TOLERABILITY; DRUG WITHDRAWAL; EUROPE; FATIGUE; FLU LIKE SYNDROME; FRACTURE; GASTROINTESTINAL IRRITATION; HEART ATRIUM FIBRILLATION; HUMAN; KIDNEY FAILURE; KIDNEY FUNCTION; MALAISE; MONOTHERAPY; MUSCULOSKELETAL PAIN; MYALGIA; NEPHROTOXICITY; NONHUMAN; OSTEOLYSIS; PATIENT COMPLIANCE; PATIENT MONITORING; POSTMARKETING SURVEILLANCE; POSTMENOPAUSE OSTEOPOROSIS; REVIEW; SIDE EFFECT; TREATMENT RESPONSE; UNITED STATES;

BONE DENSITY; BONE DENSITY CONSERVATION AGENTS; CLINICAL TRIALS AS TOPIC; DIPHOSPHONATES; DRUG ADMINISTRATION SCHEDULE; FEMALE; FRACTURES, BONE; HUMANS; INJECTIONS, INTRAVENOUS; OSTEOPOROSIS, POSTMENOPAUSAL; TREATMENT OUTCOME;

EID: 44649094124     PISSN: 17455057     EISSN: 17455065     Source Type: Journal    
DOI: 10.2217/17455057.4.3.219     Document Type: Review

References (54)

1. Cummings SR, Melton LJ: Epidemiology and outcomes of osteoporotic fractures. Lancet 359, 1761-1767 (2002).
2. Leibson CL, Tosteson AN, Gabriel SE, Ransom JE, Melton LJ: Mortality, disability, and nursing home use for persons with and without hip fracture: a population-based study. J. Am. Geriatr. Soc. 50, 1644-1650 (2002).
3. Bone Health and Osteoporosis: a Report of the Surgeon General. U.S. Department of Health and Human Services. Office of the Surgeon General, Rockville, MD, USA (2004).
4. Burge R, Dawson-Hughes B, Solomon DH, Wong JB, King A, Tosteson A. Incidence and economic burden of asteoporosis-related fractures in the United States, 2005-2025. J. Bone Miner. Res. 22, 465-475 (2007).
5. Briot K, Roux C: What is the role of DXA, QUS and bone markers in fracture prediction, treatment allocation and monitoring? Best Pract. Res. Clin. Rheumatol. 19, 951-964 (2005).
6. World Health Organization: Prevention and Management of Osteoporosis. World Health Organization, Geneva, Switzerland (2006).
7. 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) 12, 1-12 (2000).
8. 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. 344, 333-340 (2001).
9. 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. 71, 103-111 (2002).
10. McClung M, Benhamou CL, Man Z et al.: The efficacy and tolerability of a monthly dosing regimen of 75 mg risedronate dosed on 2 consecutive days a month for the treatment of postmenopausal osteoporosis - 1 year study results. Osteoporos. Int. 18, S217 (2007) (Abstract P8.6).
11. Reginster JY, Adami S, Lakatos P et al.: Efficacy and tolerability of once-monthly oral ibandronate in postmenopausal osteoporosis: 2 year results from the MOBILE study. Ann. Rheum. Dis. 65, 654-661 (2006).
12. Strampel W, Emkey R, Civirelli R: Safety considerations with bisphosphonates for the treatment of osteoporosis. Drug Saf. 30, 755-763 (2007).
13. Kamel HK: Update on osteoporosis management in long-term care: focus on bisphosphonates. J. Am. Med. Dir. Assoc. 8, 434-440 (2007).
14. Delmas PD, Adami S, Strugala C et al.: Intravenous ibandronate injections in postmenopausal women with osteoporosis: one-year results from the Dosing IntraVenous Administration (DIVA) study. Arthritis Rheum. 54, 1838-1846 (2006).
15. Black DM, Delmas PD, Eastell R et al.: Once-yearly zoledronic acid for treatment of postmenopausal osteoporosis. N. Engl. J. Med. 356, 1809-1822 (2007).
16. Chang JT, Green L, Beitz J: Renal failure with the use of zoledronic acid. N. Engl. J. Med. 349, 1676-1679 (2003).
17. Emkey R: Ibandronate: once-monthly and intravenous dosing options for osteoporosis treatment. Womens Health 2, 341-349 (2006).
18. Fleisch HF: Bisphosphonates: mechanisms of action. Endocr. Rev. 19, 80-100 (1998).
19. 45Ca kinetics in the intact rat. Osteoporos. Int. 6, 166-170 (1996).
20. Croom KF, Scott LJ: Intravenous ibandronate: in the treatment of osteoporosis. Drugs 66, 1593-1601; discussion 1602-1603 (2006).
21. Barrett J, Worth E, Bauss F, Epstein S: Ibandronate: a clinical pharmacological and pharmacokinetic update. J. Clin. Pharmacol. 44, 951-965 (2004).
22. Coxon FP, Thompson Y, Rogers MJ: Recent advances in understanding the mechanism of action of bisphosphonates. Curr. Opin. Pharmacol. 6, 307-312 (2006).
23. Leeming DJ, Alexandersen P, Karsdal MA, Qvist P, Schaller S, Tanko LB: An update on biomarkers of bone turnover and their utility in biomedical research and clinical practice. Eur. J. Clin. Pharmacol. 62, 781-792 (2006).
24. Bonnick SL, Shulman L: Monitoring osteoporosis therapy: bone mineral density, bone turnover markers, or both? Am. J. Med. 119, S25-S31 (2006).
25. Silverman SL, Barrett-Connor E, Simonelli C, Kohles JD, Dasic G, Binkley NC: Oral monthly ibandronate is associated with rapid suppression of serum CTX within three days of treatment initiation. J Bone Miner. Res. 22(Suppl. 1), S455 (2007) (Abstract W367).
26. Papapoulos SE, Schimmer RC: Changes in bone remodelling and antifracture efficacy of intermittent bisphosphonate therapy: implications from clinical studies with ibandronate. Ann. Rheum. Dis. 66, 853-858 (2007).
27. Recker R, Stakkestad JA, Chesnut CH 3rd et al.: Insufficiently dosed intravenous ibandronate injections are associated with suboptimal antifracture efficacy in postmenopausal osteoporosis. Bone 34, 890-899 (2004).
28. Adami S, Felsenberg D, Christiansen C et al.: Efficacy and safety of ibandronate given by intravenous injection once every 3 months. Bone 34, 881-889 (2004).
29. Eisman JA, Civitelli R, Adami S et al.: Efficacy and tolerability of intravenous ibandronate injections in postmenopausal osteoporosis: 2-year results from the DIVA study. J. Rheumatol (2008) (Epub ahead of print).
30. Chesnut IC, Skag A, Christiansen C et al.: Effects of oral ibandronate administered daily or intermittently on fracture risk in postmenopausal osteoporosis. J. Bone Miner. Res. 19, 1241-1249 (2004).
31. Harris ST, Watts NB, Li Z, Chines AA, Hanley DA, Brown JP: Two-year efficacy and tolerability of risedronate once a week for the treatment of women with postmenopausal osteoporosis. Curr. Med. Res. Opin. 20, 757-764 (2004).
32. Zaidi M, Epstein S, Harris ST, Kohles JD, Chesnut CH: Progression of efficacy with ibandronate: a paradigm for the development of new bisphosphonates. Ann. NY Acad. Sci. 1117, 273-282 (2007).
33. Adachi J, Wells G, Papapoulos S, Cranney A, SCIENCE Meta-Analysis Group: A meta-analysis of individual patient data: significant reduction in non-vertebral fractures with high- versus low-dose ibandronate. J. Bone Miner. Res. 22(Suppl. 1), S210 (2007) (Abstract M428).
34. Cranney A, Wells G, Adachi J: Non-vertebral fracture reduction with high- versus low-dose ibandronate: a meta-analysis of individual patient data. Ann. Rheum. Dis. 66, 681 (2007).
35. Miller PD, Harris ST, Blumentals WA: Clinical and nonvertebral fracture iisk is reduced with the use of ibandronate in women with postmenopausal osteoporosis. J. Bone Miner. Res. 22(Suppl. 1), S451 (2007) (Abstract W355).
36. Lewiecki EM, Babbitt AM, Piziak VK, Ozturk Z, Bone HG: Adherence and gastrointestinal tolerability to oral and intravenous ibandronate in patients with prior gastrointestinal intolerance to oral bisphosphonates. Clin. Therap. (2008) (In Press).
37. Woo SB, Hellstein JW, Kalmar JR: Narrative (corrected) review: bisphosphonates and osteonecrosis of the jaws. Ann. Intern. Med. 144, 753-761 (2006).
38. Food and Drug Administration: Early communication of an ongoing safety review. Bisphosphonates: alendronate (Fosamax, Fosamax Plus D®), etidronate (Didronel®), ibandronate (Boniva®), pamidronate (Aredia®), risedronate (Actonel, Actonel w/Calcium®), tiludronate (Skelid®) and zoledronic acid (Reclast, Zometa®). 1 October, 2007, US FDA Rockville, MD, USA (2007).
39. Food and Drug Administration: Information for healthcare professionals. Bisphosphonates: alendronate (Fosamax, Fosamax Plus D®), etidronate (Didronel®), ibandronate (Boniva®), pamidronate (Aredia®), risedronate (Actonel, Actonel w/Calcium®), tiludronate (Skefid®) and zoledronic acid (Reclast, Zometa®). 7 January, 2008, US FDA Rockville, MD, USA (2008).
40. Bukowski JF, Dascher CC, Das H: Alternative bisphosphonate targets and mechanisms of action. Biochem. Biophys. Res. Commun. 328, 746-750 (2005).
41. Ringe JD, Schacht E: Improving the outcome of established therapies for osteoporosis by adding the active D-hormone analog alfacalcidol. Rheumatol. Int. 28, 103-111 (2007).
42. Schacht E, Dukas L, Richy F: Combined therapies in osteoporosis: bisphosphonates and vitamin D-hormone analogs. J. Musculoskelet. Neuronal Interact. 7, 174-184 (2007).
43. Black DM, Greenspan SL, Ensrud KE et al.: The effects of parathyroid hormone and alendsonate alone or in combination in postmenopausal osteoporosis. N. Engl. J. Med. 349, 1207-1215 (2003).
44. Finkelstein JS, Leder BZ, Burnett SM et al.: Effects of teriparatide, alendronate, or both on bone turnover in osteoporotic men. J. Clin. Endocrinol. Metab. 91, 2882-2887 (2006).
45. Black DM, Bilezikian JP, Ensrud KE et al.: One year of alendronate after one year of parathyroid hormone (1-84) for osteoporosis. N. Engl. J. Med. 353, 555-565 (2005).
46. Kurland ES, Heller SL, Diamond B, McMahon DJ, Cosman F, Bilezikian JP: The importance of bisphosphonate therapy in maintaining bone mass in men after therapy with teriparatide (human parathyroid hormone[1-34]). Osteoporos. Int. 15, 992-997 (2004).
47. 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. 62, 969-975 (2003).
48. McClung MR, Lewiecki EM, Cohen SB et al.: Denosumab in postmenopausal women with low bone mineral density. N. Engl. J. Med. 354, 821-831 (2006).
49. van Bezooijen RL, Svensson JP, Eefting D et al.: Wnt but not BMP signaling is involved in the inhibitory action of sclerostin on BMP-stimulated bone formation. J. Bone Miner. Res. 22, 19-28 (2007).
50. Robling AG, Niziolek PJ, Baldridge LA et al.: Mechanical stimulation of bone in vivo reduces osteocyte expression of Sost/ sclerostin. J. Biol. Chem. 283, 5866-5875 (2008).
51. Ominsky MS, Asuncion FJ, Tan HL et al.: Sclerostin monoclonal antibody increases bone strength in aged osteopenic ovariectomized rats. J. Bone Miner. Res. 21(Suppl. 1), S44 (2006) (Abstract 1161).
52. Ominsky MS, Stouch B, Doellgast G et al.: Administration of sclerostin monoclonal antibodies to female cynomolgus monkeys results in increased bone formation, bone mineral density and bone strength. J. Bone Miner. Res. 21(Suppl. 1), S44 (2006) (Abstract 1162).
53. TM and the assessment of 10-year fracture probability in men and women from the UK. Osteoporos. Int. 19(4), 385-397 (2008).
54. Dawson-Hughes B, Tosteson ANA, Melton III LJ et al.: Implications of absolute fracture risk assessment for osreoporosis practice guidelines in the USA. Osteoporos. Int. 19(4), 449-458 (2008).