A randomized, double-blind comparison of risedronate and etidronate in the treatment of Paget's disease of bone

American Journal of Medicine

Volumn 106, Issue 5, 1999, Pages 513-520

  Miller, Paul D ^a   Brown, Jacques P ^b   Siris, Ethel S ^c   Hoseyni, Mohammad S ^d   Axelrod, Douglas W ^d   Bekker, Pirow J ^d  

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

^b LAVAL UNIVERSITY   (Canada)

^c Columbia Univ Coll of Phys and S ^*  (United States)

^d PROCTER AND GAMBLE PHARMACEUTICALS   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ALKALINE PHOSPHATASE; ALKALINE PHOSPHATASE BONE ISOENZYME; DEOXYPYRIDINOLINE; ETIDRONIC ACID; PLACEBO; RISEDRONIC ACID;

ADULT; AGED; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG TOLERABILITY; FEMALE; GASTROINTESTINAL TOXICITY; HEADACHE; HUMAN; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NAUSEA; ORAL DRUG ADMINISTRATION; PAGET BONE DISEASE; PAIN ASSESSMENT; PRIORITY JOURNAL; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL;

ADMINISTRATION, ORAL; AGED; ALKALINE PHOSPHATASE; BONE AND BONES; CALCIUM CHANNEL BLOCKERS; DOUBLE-BLIND METHOD; ETIDRONIC ACID; FEMALE; HUMANS; MALE; MIDDLE AGED; OSTEITIS DEFORMANS; PAIN; RECURRENCE; TREATMENT OUTCOME;

EID: 0033135850     PISSN: 00029343     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0002-9343(99)00062-5     Document Type: Article

References (50)

1. Siris E.S. Paget's disease of bone. Favus M.J., Primer on the Metabolic Bone Diseases and Disorders of Mineral Metabolism. 1996;409-419 Raven Press, New York.
2. Heath D.A. Treating Paget's disease. BMJ. 294:1987;1048-1050.
3. Wallach S. Paget's disease of bone. Calkins E., Davis P.J., Ford A.B., The Practice of Geriatrics. 1986;431-440 WB Saunders, Philadelphia, PA.
4. Singer F.R. Paget's disease of bone. Hazzard W.R., Andres R., Bierman E.L., Favus M.J., Principles of Geriatric Medicine and Gerontology. 2nd ed. 1990;843-848 McGraw-Hill, New York.
5. Harinck H.I., Papapoulos S.E., Blanksma H.J., et al. Paget's disease of bone early and late responses to three different modes of treatment with aminohydroxypropylidene bisphosphonate (APD) . BMJ. 295:1987;1301-1305.
6. Thiébaud D., Jaeger P., Gobelet C., et al. A single infusion of the bisphosphonate AHPrBP (APD) as treatment of Paget's disease of bone. Am J Med. 85:1988;207-212.
7. Stone M.D., Hawthorne A.B., Kerr D., et al. Treatment of Paget's disease with intermittent low-dose infusions of disodium pamidronate (APD). J Bone Miner Res. 5:1990;1231-1235.
8. Watts R.A., Skingle S.J., Bhambhani M.M., et al. Treatment of Paget's disease of bone with single dose intravenous pamidronate. Ann Rheum Dis. 52:1993;616-618.
9. Fenton A.J., Gutteridge D.H., Kent G.N., et al. Intravenous aminobisphosphate in Paget's disease clinical, biochemical, histomorphometric and radiological responses . Clin Endocrinol. 34:1991;197-204.
10. Siris E., Weinstein R.S., Altman R., et al. Comparative study of alendronate versus etidronate for the treatment of Paget's disease of bone. J Clin Endocrinol Metab. 81:1996;961-967.
11. Reid I.R., Nicholson G.C., Weinstein R.S., et al. Biochemical and radiologic improvement in Paget's disease of bone treated with alendronate a randomized, placebo-controlled trial . Am J Med. 101:1996;341-348.
12. Reginster J.Y., Jeugmans-Huynen A.M., Albert A., et al. Biological and clinical assessment of a new bisphosphonate, (chloro-4 phenyl) thiomethylene bisphosphonate, in the treatment of Paget's disease of bone. Bone. 9:1988;349-354.
13. Reginster J.Y., Lecart M.P., Deroisy R., et al. Paget's disease of bone treated with five day course of oral tiludronate. Ann Rheum Dis. 52:1993;54-57.
14. Roux C., Gennari C., Farrerons J., et al. Comparative prospective, double-blind, multicenter study of the efficacy of tiludronate and etidronate in the treatment of Paget's disease of bone. Arthritis Rheum. 38:1995;851-858.
15. Audran M., Clochon P., Ethgen D., et al. Treatment of Paget's disease of bone with (4-chloro-phenyl)thiomethylene bisphosphonate. Clin Rheumatol. 8:1989;71-79.
16. Siris E.S., Canfield R.E., Jacobs T.P., et al. Clinical and biochemical effects of EHDP in Paget's disease of bone patterns of response to initial treatment and to long-term therapy . Metab Bone Dis Relat Res. 3:1981;301-308.
17. Siris E.S., Canfield R.E., Jacobs T.P., Baquiran D.C. Long-term therapy of Paget's disease of bone with EHDP. Arthritis Rheum. 23:1980;1177-1184.
18. Johnston C.C. Jr, Khairi M.R., Meunier P.J. Use of etidronate (EHDP) in Paget's disease of bone. Arthritis Rheum. 23:1980;1172-1176.
19. Khairi M.R.A., Altman R.D., DeRosa G.P., et al. Sodium etidronate in the treatment of Paget's disease of bone. A study of long-term results. Ann Intern Med. 87:1977;656-663.
20. Smith R., Russell R.G.G. Treatment of Paget's disease with a diphosphonate (sodium etidronate). Semin Drug Treat. 2:1972;77-81.
21. Delmas P.D., Meunier P.J. The management of Paget's disease of bone. NEJM. 336:1997;558-566.
22. Muir H.G., Schabort I., Hough F.S. Influence of disodium etidronate on Paget's disease of bone. S Afr Med J. 72:1987;470-472.
23. Canfield R., Rosner W., Skinner J., et al. Diphosphonate therapy of Paget's disease of bone. J Clin Endocrinol Metab. 44:1977;96-106.
24. Geddes A.D., D'Souza S.M., Ebetino F.H., Ibbotson K.J. Bisphosphonates structure-activity relationships and therapeutic implications . Heersche J.N.M., Kanis J.A., Bone and Mineral Research. 1994;265-274 Elsevier Science, Amsterdam, Netherlands.
25. Altman RD, Collins B. Disodium etidronate (EHDP) in Paget's disease (Pag D): 11 year study of 93 patients. Arthritis Rheum. 1983;26(suppl.):S9. Abstract.
26. Meunier P.J., Ravault A. Treatment of Paget's disease with etidronate disodium. Singer F.R., Wallach S., Paget's Disease of Bone Clinical Assessment, Present and Future Therapy . 1991;86-99 Elsevier, New York.
27. Mautalen C.A., Gonzalez D., Ghiringhelli G. Efficacy of the bisphosphonate APD in the control of Paget's bone disease. Bone. 6:1985;429-432.
28. Heynen G., Delwaide P., Bijvoet O.L.M., Franchimont P. Clinical and biological effects of low doses of (3 amino-1 hydroxypropylidene)-1,1-bisphosphonate (APD) in Paget's disease of bone. Eur J Clin Invest. 12:1982;29-35.
29. Lufkin E.G., Argueta R., Whitaker M.D., et al. Pamidronate an unrecognized problem in gastrointestinal tolerability . Osteoporos Int. 4:1994;320-322.
30. de Groen P.C., Lubbe D.F., Hirsch L.J., et al. Esophagitis associated with the use of alendronate. NEJM. 335:1996;1016-1021.
31. Castell D.O. "Pill esophagitis": the case of alendronate . NEJM. 335:1996;1058-1059.
32. Adami S., Mian M., Gatti P., et al. Effects of two oral doses of alendronate in the treatment of Paget's disease of bone. Bone. 15:1994;415-417.
33. Bijvoet O.L.M., Frijlink W.B., Jie K., et al. APD in Paget's disease of bone. Role of the mononuclear phagocyte system? Arthritis Rheum. 23:1980;1193-1204.
34. O'Doherty D.P., McCloskey E.V., Vasikaran S., et al. The effects of intravenous alendronate in Paget's disease of bone. J Bone Miner Res. 10:1995;1094-1100.
35. Kanis J. Differential diagnosis. Kanis J., Pathophysiology and Treatment of Paget's Disease of Bone. 1991;139-158 Martin Dunitz Ltd, London, UK.
36. Mitchell DY, Eusebio RA, Heise MA, et al. The effect of dosing regimen on the pharmacokinetics of risedronate administered to healthy subjects. J Bone Miner Res. 1996;11(suppl. 1):S347. Abstract M661.
37. Bowers G.N. Jr, McComb R.B. A continuous spectrophotometric method for measuring the activity of serum alkaline phosphatase. Clin Chem. 12:1966;70-89.
38. Tietz N.W., Burtis C.A., Duncan P., et al. A reference method for measurement of alkaline phosphatase activity in human serum. Clin Chem. 29:1983;751-761.
39. Ware J.E. Jr, Sherbourne C. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 30:1992;473-483.
40. Ware JE Jr. SF-36 Health Survey Manual and Interpretation Guide. Boston, MA: The Health Institute, New England Medical Center, 1993.
41. Ware JE Jr. SF-36 Physical and Mental Health Summary Scales: A User's Manual. Boston, MA: The Health Institute, New England Medical Center, 1994.
42. Alvarez L., Guanabens N., Peris P., et al. Discriminative value of biochemical markers of bone turnover in assessing the activity of Paget's disease. J Bone Miner Res. 10:1995;458-465.
43. Meunier P.J., Salson C., Mathieu L., et al. Skeletal distribution and biochemical parameters of Paget's disease. Clin Orthop. 217:1987;37-44.
44. Singer FR, Fredericks RS, Minkin C. Salmon calcitonin therapy for Paget's disease of bone. The problem of acquired clinical resistance. Arthritis Rheum 1980;23:1148-1154. Review.
45. Haddad J.G. Jr, Caldwell J.G. Calcitonin resistance clinical and immunologic studies in subjects with Paget's disease of bone treated with porcine and salmon calcitonins . J Clin Invest. 51:1972;3133-3141.
46. Dietrich F.M., Fischer J.A., Bijvoet O.L.M. Formation of antibodies to synthetic human calcitonin during treatment of Paget's disease. Acta Endocrinol. 92:1979;468-476.
47. Singer F.R., Aldred J.P., Neer R.M., et al. An evaluation of antibodies and clinical resistance to salmon calcitonin. J Clin Invest. 51:1972;2331-2338.
48. Altman R.D., Johnston C.C. Jr, Khairi M.R., et al. Influence of disodium etidronate on clinical and laboratory manifestation of Paget's disease of bone (osteitis deformans). NEJM. 289:1973;1379-1384.
49. Berenson J.R., Lichtenstein A., Porter L., et al. Efficacy of pamidronate in reducing skeletal events in patients with advanced multiple myeloma. NEJM. 334:1996;488-493.
50. Hortobagyi G.N., Theriault R.L., Porter L., et al. Efficacy of pamidronate in reducing skeletal complications in patients with breast cancer and lytic bone metastases. NEJM. 335:1996;1785-1791.