Clinical utility of clodronate in the prevention and management of osteoporosis in patients intolerant of oral bisphosphonates

Drug Design, Development and Therapy

Volumn 5, Issue , 2011, Pages 445-454

  Muratore, Maurizio ^a   Quarta, Eugenio ^a   Grimaldi, Antonella ^a   Calcagnile, Fabio ^a   Quarta, Laura ^a  

^a Hospital Galateo   (Italy)

Author keywords

Bisphosphonates; Bone turnover; Clodronate; Menopause; Osteoporosis; Tolerability

Indexed keywords

ALENDRONIC ACID; BISPHOSPHONIC ACID DERIVATIVE; CLODRONIC ACID; PAMIDRONIC ACID; PLACEBO; RISEDRONIC ACID; ZOLEDRONIC ACID;

ANTIINFLAMMATORY ACTIVITY; BONE CANCER; BONE DENSITY; BONE DISEASE; BONE METASTASIS; BREAST CANCER; CANCER PREVENTION; COST BENEFIT ANALYSIS; COST EFFECTIVENESS ANALYSIS; COST OF ILLNESS; DIARRHEA; DISEASE ASSOCIATION; DOSE RESPONSE; DRUG BIOAVAILABILITY; DRUG DOSE COMPARISON; DRUG EFFECT; DRUG EFFICACY; DRUG INDICATION; DRUG MECHANISM; DRUG METABOLISM; DRUG SAFETY; DRUG TOLERABILITY; FRAGILITY FRACTURE; GASTROINTESTINAL SYMPTOM; HEART ATRIUM FIBRILLATION; HIGH RISK PATIENT; HUMAN; HYPERCALCEMIA; INTERMETHOD COMPARISON; JAW OSTEONECROSIS; KIDNEY FAILURE; NAUSEA; NONHUMAN; OSTEOPOROSIS; OUTCOME ASSESSMENT; PAGET BONE DISEASE; PATIENT COMPLIANCE; POSTMENOPAUSE OSTEOPOROSIS; PREVALENCE; REVIEW; RHEUMATOID ARTHRITIS; RISK ASSESSMENT; RISK FACTOR; RISK REDUCTION; SEX DIFFERENCE; VOMITING;

CLODRONIC ACID; DIPHOSPHONATES; FEMALE; HUMANS; MALE; OSTEOPOROSIS; OSTEOPOROSIS, POSTMENOPAUSAL;

EID: 84859150009     PISSN: 11778881     EISSN: None     Source Type: Journal    
DOI: 10.2147/DDDT.S12139     Document Type: Review

References (70)

1. ISS: Osteoporosi: una malattia sociale, costi assistenziali, interventi terapeutici.[Osteoporosis: a social disease, healthcare costs, therapeutic interventions]. Available from: http://www.salute.gov.it/resources/static/primopiano/278/scheda%20ISS%20def%20.pdf. Accessed August 5, 2011. (Italian)
2. Kanis JA. World Health Organization Technical Report. University of Sheffield, UK: 2007.
3. National Osteoporosis Foundation. Clinician's Guide to Prevention and Treatment of Osteoporosis. Washington, DC: National Osteoporosis Foundation; 2010.
4. Frediani B, Cavalieri L, Cremonesi G. Clodronic acid formulations available in Europe and their use in osteoporosis. A review. Clin Drug Invest. 2009;29:359-379.
5. Ghinoi V, Brandi ML. Clodronate: Mechanisms of action on bone remodelling and clinical use in osteometabolic disorders. Expert Opin Pharmacother. 2002;3:1643-1656.
6. Pharmacogenomics Knowledge Base. Available from: http://www.pharmgkb.org/do/serve?objCls=Pathway&objId=PA154423660#PGG.
7. Bertoldo F, Dalle Carbonare L, Pancheri S. L'osteonecrosi della mandibola associate alla terapia dei bifosfonati. Bifosfonati. 2007;2: 3-21. Italian.
8. Cremers SC, Pillai G, Papapoulo SE. Pharmacokinetics/pharmacodynamics of bisphosphonates: Use for optimization of intermittent therapy for osteoporosis. Clin Pharmacokinet. 2005;44:551-570.
9. Dando TM, Wiseman LR. Clodronate: A review of its use in the prevention of bone metastases and the management of skeletal complications associated with bone metastases in patients with breast cancer. Drugs Aging. 2004;21:949-962.
10. Diel J, Bergener R, Grotz K. Adverse effects of bisphosphonates: Current issues. J Support Oncol. 2007;5:475-482.
11. Filipponi P, Cristallini S, Rizzello E, et al. Cyclical intravenous clodronate in postmenopausal osteoporosis: Results of a long-term clinical trial. Bone. 1996;18:179-184.
12. McCloskey E, Selby P, Davies M, et al. Clodronate reduces vertebral fracture risk in women with postmenopausal or secondary osteoporosis: Results of a double-blind, placebo controlled 3-year study. J Bone Miner Res. 2004;19:728-736.
13. Benford HL, McGowan NW, Helfrich MH, et al. Visualization of bisphosphonate-induced caspase-3 activity in apoptotic osteoclasts in vitro. Bone. 2001;28:465-473.
14. Solomon CG. Bisphosphonates and osteoporosis. N Engl J Med. 2002;346:642.
15. Brandi ML. Impiego del clodronato nei disordini del metabolismo minerale. Stato dell'arte nell'anno 2000 [Use of clodronate in dysfunction of mineral metabolism. State of the art in the year 2000]. Minerva Med. 2001;92:251-268. (Italian)
16. Chesnut CH. Synthetic Calcitonin, Diphosphonates and Anabolic Steroids in the Treatment of Postmenopausal Osteoporosis. Copenhagen, Denmark: Osteopress; 1984.
17. Giannini S, D'Angelo A, Malvasi L, et al. Effects of one-year cyclical treatment with clodronate on postmenopausal bone loss. Bone. 1993;14:137-141.
18. Filipponi P, Pedetti M, Fedeli L, et al. Cyclical clodronate is effective in preventing postmenopausal bone loss: A comparative study with transcutaneous hormone replacement therapy. J Bone Miner Res. 1995;10:697-703.
19. Rossini M, Braga V, Gatti D, Zamberlan N, Bianchini D, Adami S. Intramuscular intermittent clodronate in the treatment of postmenopausal osteoporosis. Bone. 1995:6:606.
20. Filipponi P, Cristallini S, Rizzello E, et al. Cyclical intravenous clodronate in postmenopausal osteoporosis: Results of a long-term clinical trial. Bone. 1996;18:179-184.
21. McCloskey EV, Beneton M, Charlesworth D, et al. Clodronate reduces the incidence of fractures in community-dwelling elderly women unselected for osteoporosis: Results of a double-blind, placebo-controlled randomized study. J Bone Miner Res. 2007;22:135-141.
22. Frediani B. Effects of two administration schemes of intramuscular clodronic acid on bone mineral density. A randomized, open-label, parallel-group study. Clin Drug Investig. 2011;31:43-50.
23. Dominguez LJ, Galioto A, Ferlisi A, et al. Intermittent intramuscular clodronate therapy: A valuable option for older osteoporotic women. Age Ageing. 2005;34:633-636.
24. Frediani B, Falsetti P, Baldi F, et al. Effects of 4-year treatment with onceweekly clodronate on prevention of corticosteroid-induced bone loss and fractures in patients with arthritis: Evaluation with dual-energy x-ray absorptiometry and quantitative ultrasound. Bone. 2003;33: 575-581.
25. Itoh F, Aoyagi S, Kusama H, et al. Effects of clodronate and alendronate on local and systemic changes in bone metabolism in rats with adjuvant arthritis. Inflammation. 2004;28:15-21.
26. Funayama H, Mayanagi H, Takada H, et al. Elevation of histidine decarboxylase activity in the mandible of mice by Prevotella intermedia lipopolysaccharide and its augmentation by an aminobisphosphonate. Arch Oral Biol. 2000;45:787-795.
27. Yamaguchi K, Motegi K, Iwakura Y, et al. Involvement of interleukin-1 in the inflammatory actions of aminobisphosphonates in mice. Br J Pharmacol. 2000;130:1646-1654.
28. Oelzner P, Kunze A, Henzgen S, et al. High-dose clodronate therapy prevents joint destruction in chronic antigen-induced arthritis of the rat but inhibits bone formation at the axial skeleton. Inflamm Res. 2000;49: 424-433.
29. Muscoso E, Puglisi N, Mamazza C, et al. Antiresorption therapy and reduction in fracture susceptibility in the osteoporotic elderly patient: Open study. Eur Rev Med Pharmacol Sci. 2004;8:97-102.
30. Rossini M, Bianchi G, Di Munno O, et al. Treatment of Osteoporosis in clinical Practice (TOP) Study Group. Determinants of adherence to osteoporosis treatment in clinical practice. Osteoporos Int. 2006;17: 914-921.
31. Berg JS, Dischler J, Wagner DJ, Raia JJ, Palmer-Shevlin N. Medication compliance: A healthcare problem. Ann Pharmacother. 1993;27(Suppl 9): S1-S24.
32. Miller NH. Compliance with treatment regimens in chronic asymptomatic diseases. Am J Med. 1997;102:43-49.
33. Tosteson AN, Grove MR, Hammond CS, et al. Early discontinuation of treatment for osteoporosis. Am J Med. 2003;115:209-216.
34. Turbi C, Herrero-Beaumont G, Acebes JC, et al. Compliance and satisfaction with raloxifene versus alendronate for the treatment of postmenopausal osteoporosis in clinical practice: An open label, prospective, nonrandomized, observational study. Clin Ther. 2004;26:245-256.
35. Lombas C, Hakim C, Zanchetta JR. Compliance with alendronate treatment in an osteoporosis clinic. J Bone Miner Res. 2001;15 Suppl 1:S529.
36. Muratore M, Quarta L, Calcagnile F, Quarta E. "Twice-a-month" clodronate 200 mg IM: A new dosing regimen and improved therapy adherence in the treatment of postmenopausal osteoporosis. Adv Ther. 2010;27:314-320.
37. Penning-van Beest FJ, Erkens JA, Olson M, Herings RM. Determinants of non-compliance with bisphosphonates in women with postmenopausal osteoporosis. Curr Med Res Opin. 2008;24:1337-1344.
38. Herrala J, Puolijoki H, Liippo K, et al. Clodronate is effective in preventing corticosteroid-induced bone loss among asthmatic patients. Bone. 1998;22:577-582.
39. 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. 2006;65:654-661.
40. Miller PD. Optimizing the management of postmenopausal osteoporosis with bisphosphonates: The emerging role of intermittent therapy. Clin Ther. 2005;27:361-376.
41. McCloskey EV, Johansson H, Oden A, et al. Ten-year fracture probability identifies women who will benefit from clodronate therapy-additional results from a double-blind, placebo-controlled randomised study. Osteoporos Int. 2009;20:811-817.
42. www.fda.gov/Safety/Medwatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm264087.htm. Accessed August 5, 2011.
43. Ruggiero SL, Mehrotra B, Rosenberg TJ, Engroff SL. Osteonecrosis of the jaws associated with the use of bisphosphonates: A review of 63 cases. J Oral Maxillofac Surg. 2004;62:527-534.
44. Khosla S, Burr D, Cauley J, et al; American Society for Bone and Mineral Research. Bisphosphonate-associated osteonecrosis of the jaw: Report of a task force of the American Society for Bone and Mineral Research. J Bone Miner Res. 2007;22:1479-1491.
45. Marx RE, Sawatari Y, Fortin M, Broumand V. Bisphosphonate-induced exposed bone (osteonecrosis/osteopetrosis) of the jaws: Risk factors, recognition, prevention, and treatment. J Oral Maxillofac Surg. 2005;63:1567-1575.
46. Diel IJ, Fogelman I, Al-Nawas B, et al. Pathophysiology, risk factors and management of bisphosphonate associated osteonecrosis of the jaw: Is there a diverse relationship of amino-and non-aminobisphosphonates? Crit Rev Oncol Hematol. 2007;64:198-207.
47. Cummings SR, Schwartz AV, Black DM. Alendronate and atrial fibrillation. N Engl J Med. 2007;356:1895-1896.
48. Black DM, Delmas PD, Eastell R, et al; HORIZON Pivotal Fracture Trial. Once-yearly zoledronic acid for treatment of postmenopausal osteoporosis. N Engl J Med. 2007;356:1809-1822.
49. Bhuriya R, Singh M, Molnar J, Arora R, Khosla S. Bisphosphonate use in women and the risk of atrial fibrillation: A systematic review and meta-analysis. Int J Cardiol. 2010;142:213-217.
50. Kim SY, Kim MJ, Cadarette SM, Solomon DH. Bisphosphonates and risk of atrial fibrillation: A meta-analysis. Arthritis Res Ther. 2010;12:R30.
51. [No authors listed]. Bisphosphonates and atrial fibrillation: Clinical trial data suggest possible link. Prescrire Int. 2011;20:96-97.
52. Endo Y, Shibazaki M, Yamaguchi K, et al. Inhibition of inflammatory actions of aminobisphosphonates by dichloromethylene bisphosphonate, a non-aminobisphosphonate. Br J Pharmacol. 1999;126:903-910.
53. Liu L, Igarashi K, Kanzaki H, et al. Clodronate inhibits PGE(2) production in compressed periodontal ligament cells. J Dent Res. 2006;85:757-760.
54. Bonabello A, Galmozzi MR, Bruzzese T, et al. Analgesic effect of bisphosphonates in mice. Pain. 2001;91:269-275.
55. Rovetta G, Monteforte P. Efficacy of disodium-clodronate in the management of joint pain in rheumatoid arthritis: Six months open study. Minerva Med. 2003;94:353-357.
56. Saviola G, Santoro L. Clodronate in erosive osteoarthrosis of the hand: Efficacy for pain and function recovery. G Ital Med Lav Ergon. 2000;22:328-331. Italian.
57. Varenna M, Zucchi F, Ghiringhelli D, et al. Intravenous clodronate in the treatment of reflex sympathetic dystrophy syndrome: A randomized, double blind, placebo controlled study. J Rheumatol. 2000;27:1477-1483.
58. Douglas DL, Duckworth T, Russell RG, et al. Effect of dichloromethylene diphosphonate in Paget's disease of bone and in hypercalcaemia due to primary hyperparathyroidism or malignant disease. Lancet. 1980;1:1043-1047.
59. Adami S, Bertoldo F, Brandi ML, et al. Guidelines for the diagnosis, prevention and treatment of osteoporosis. Reumatismo. 2009;61: 260-284. Italian.
60. Minisola S, Nuti R, Rini G, 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;15:792-798.
61. 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;282:1344-1352.
62. 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;280:2077-2082.
63. 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.
64. 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;344:333-340.
65. Wainwright SA, Marshall LM, Ensrud KE, et al. Hip fracture in women without osteoporosis. J Clin Endocrinol Metab. 2005;90: 2787-2793.
66. Siris ES, Chen YT, Abbott TA, et al. Bone mineral density thresholds for pharmacological intervention to prevent fractures. Arch Intern Med. 2004;164:1108-1112.
67. Kanis JA, Oden A, Johnell O, et al. The use of clinical risk factors enhances the performance of BMD in the prediction of hip and osteoporotic fractures in men and women. Osteoporos Int. 2007;18:1033-1046.
68. Kanis JA, McCloskey EV, Johansson H, Oden A, Ström O, Borgström F. Development and use of FRAX in osteoporosis. Osteoporos Int. 2010;21 Suppl 2:S407-S413.
69. Ringe JD, Möller G. Differences in persistence, safety and efficacy of generic and original branded once weekly bisphosphonates in patients with postmenopausal osteoporosis: 1-year results of a retrospective patient chart review analysis. Rheumatol Int. 2009;30:213-221.
70. Kendler DL, Bessette L, Hill CD, et al. Preference and satisfaction with a 6-month subcutaneous injection versus a weekly tablet for treatment of low bone mass. Osteoporos Int. 2010;21:837-846.