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Claims for Patent: 6,015,801

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Claims for Patent: 6,015,801

Title: Method for inhibiting bone resorption
Abstract:Disclosed are methods for inhibiting bone resorption in mammals while minimizing the occurrence of or potential for adverse gastrointestinal effects. Also disclosed are pharmaceutical compositions and kits for caring out the therapeutic methods disclosed herein.
Inventor(s): Daifotis; Anastasia G. (Westfield, NJ), Yates; A. John (Westfield, NJ), Santora, II; Arthur C. (Watchung, NJ)
Assignee: Merck & Co., Inc. (Rahway, NJ)
Application Number:09/134,215
Patent Claims: 1. A method for treating a condition or disease state in a mammal, said disease state or condition selected from the group consisting of Paget's disease, abnormally increased bone turnover, periodontal disease, tooth loss, bone fractures, metastatic bone disease, hypercalcemia of malignancy, and multiple myeloma, said method comprising orally administering to said mammal a pharmaceutically effective amount of a unit dosage of a bisphosphonate according to a continuous schedule having a dosing interval selected from the group consisting of once-weekly dosing, twice-weekly dosing, biweekly dosing, and twice-monthly dosing.

2. A method according to claim 1 wherein said bisphosphonate is selected from the group consisting of alendronate, cimadronate, clodronate, tiludronate, etidronate, ibandronate, risedronate, piridronate, pamidronate, zolendronate, pharmaceutically acceptable salts or esters thereof, and mixtures thereof.

3. A method according to claim 2 wherein said bisphosphonate is selected from the group consisting of alendronate, pharmaceutically acceptable salts or esters thereof, and mixtures thereof.

4. A method according to claim 3 wherein said pharmaceutically acceptable salt is alendronate monosodium trihydrate.

5. A method according to claim 2 wherein said bisphosphonate is selected from the group consisting of risedronate, pharmaceutically acceptable salts or esters thereof, and mixtures thereof.

6. A method according to claim 4 wherein said mammal is a human.

7. A method according to claim 6 wherein said dosing interval is once-weekly.

8. A method according to claim 7 wherein said unit dosage of said bisphosphonate comprises about 70 mg of alendronate monosodium trihydrate, on an alendronic acid active basis.

9. A method according to claim 6 wherein said dosing interval is twice-weekly.

10. A method according to claim 8 wherein said unit dosage of said bisphosphonate comprises about 35 mg of alendronate monosodium trihydrate, on an alendronic acid active basis.

11. A method according to claim 6 wherein said dosing interval is biweekly.

12. A method according to claim 11 wherein said unit dosage of said bisphosphonate comprises about 140 mg of alendronate monosodium trihydrate, on an alendronic acid active basis.

13. A method according to claim 6 wherein said dosing interval is twice-monthly.

14. A method according to claim 13 wherein said unit dosage of said bisphosphonate comprises about 140 mg of alendronate monosodium trihydrate, on an alendronic acid active basis.

15. A method for preventing a condition or disease state in a mammal in need thereof, said disease state or condition selected from the group consisting of Paget's disease, abnormally increased bone turnover, periodontal disease, tooth loss, bone fractures, metastatic bone disease, hypercalcemia of malignancy, and multiple myeloma, said method comprising orally administering to said mammal a pharmaceutically effective amount of a unit dosage of a bisphosphonate according to a continuous schedule having a dosing interval selected from the group consisting of once-weekly dosing, twice-weekly dosing, biweekly dosing, and twice-monthly dosing.

16. A method according to claim 15 wherein said bisphosphonate is selected from the group consisting of alendronate, cimadronate, clodronate, tiludronate, etidronate, ibandronate, risedronate, piridronate, pamidronate, zolendronate, pharmaceutically acceptable salts or esters thereof, and mixtures thereof.

17. A method according to claim 16 wherein said bisphosphonate is selected from the group consisting of alendronate, pharmaceutically acceptable salts or esters thereof, and mixtures thereof.

18. A method according to claim 17 wherein said pharmaceutically acceptable salt is alendronate monosodium trihydrate.

19. A method according to claim 16 wherein said bisphosphonate is selected from the group consisting of risedronate, pharmaceutically acceptable salts or esters thereof, and mixtures thereof.

20. A method according to claim 18 wherein said mammal is a human.

21. A method according to claim 20 wherein said dosing interval is once-weekly.

22. A method according to claim 21 wherein said unit dosage of said bisphosphonate comprises about 35 mg of alendronate monosodium trihydrate, on an alendronic acid active basis.

23. A method according to claim 20 wherein said dosing interval is twice-weekly.

24. A method according to claim 23 wherein said unit dosage of said bisphosphonate comprises about 17.5 mg of alendronate monosodium trihydrate, on an alendronic acid active basis.

25. A method according to claim 20 wherein said dosing interval is biweekly.

26. A method according to claim 25 wherein said unit dosage of said bisphosphonate comprises about 70 mg of alendronate monosodium trihydrate, on an alendronic acid active basis.

27. A method according to claim 20 wherein said dosing interval is twice-monthly.

28. A method according to claim 27 wherein said unit dosage of said bisphosphonate comprises about 70 mg of alendronate monosodium trihydrate, on an alendronic acid active basis.

29. A method for treating a condition or disease state in a mammal, said disease state or condition selected from the group consisting of Paget's disease, abnormally increased bone turnover, periodontal disease, tooth loss, bone fractures, metastatic bone disease, hypercalcemia of malignancy, and multiple myeloma, said method comprising sequentially orally administering to said mammal a pharmaceutically effective amount of a unit dosage of a histamine H2 receptor blocker or a proton pump inhibitor and a unit dosage of a bisphosphonate according to a continuous schedule having a dosing interval selected from the group consisting of once-weekly dosing, twice-weekly dosing, biweekly dosing, and twice-monthly dosing.

30. A method according to claim 21 wherein said histamine H2 blocker or said proton pump inhibitor is administered from about 30 minutes to about 24 hours prior to the administration of said bisphosphonate.

31. A method according to claim 30 wherein said bisphosphonate is selected from the group consisting of alendronate, cimadronate, clodronate, tiludronate, etidronate, ibandronate, risedronate, piridronate, pamidronate, zolendronate, pharmaceutically acceptable salts or esters thereof, and mixtures thereof.

32. A method according to claim 31 wherein said bisphosphonate is selected from the group consisting of alendronate, pharmaceutically acceptable salts or esters thereof, and mixtures thereof.

33. A method according to claim 32 wherein said pharmaceutically acceptable salt is alendronate monosodium trihydrate.

34. A method according to claim 31 wherein said bisphosphonate is selected from the group consisting of risedronate, pharmaceutically acceptable salts or esters thereof, and mixtures thereof.

35. A method according to claim 33 wherein said mammal is a human.

36. A method according to claim 35 wherein said dosing interval is once-weekly.

37. A method according to claim 36 wherein said unit dosage of said bisphosphonate comprises about 70 mg of alendronate monosodium trihydrate, on an alendronic acid active basis.

38. A method according to claim 35 wherein said dosing interval is twice-weekly.

39. A method according to claim 38 wherein said unit dosage of said bisphosphonate comprises about 35 mg of alendronate monosodium trihydrate, on an alendronic acid active basis.

40. A method according to claim 35 wherein said dosing interval is biweekly.

41. A method according to claim 39 wherein said unit dosage of said bisphosphonate comprises about 140 mg of alendronate monosodium trihydrate, on an alendronic acid active basis.

42. A method according to claim 35 wherein said dosing interval is twice-monthly.

43. A method according to claim 42 wherein said unit dosage of said bisphosphonate comprises about 140 mg of alendronate monosodium trihydrate, on an alendronic acid active basis.

44. A method for preventing a condition or disease state in a mammal in need thereof, said disease state or condition selected from the group consisting of Paget's disease, abnormally increased bone turnover, periodontal disease, tooth loss, bone fractures, metastatic bone disease, hypercalcemia of malignancy, and multiple myeloma, said method comprising sequentially orally administering to said mammal a pharmaceutically effective amount of a unit dosage of a histamine H2 receptor blocker or a proton pump inhibitor and a unit dosage of a bisphosphonate according to a continuous schedule having a dosing interval selected from the group consisting of once-weekly dosing, twice-weekly dosing, biweekly dosing, and twice-monthly dosing.

45. A method according to claim 44 wherein said histamine H2 receptor blocker or said proton pump inhibitor is administered from about 30 minutes to about 24 hours prior to the administration of said bisphosphonate.

46. A method according to claim 45 wherein said bisphosphonate is selected from the group consisting of alendronate, cimadronate, clodronate, tiludronate, etidronate, ibandronate, risedronate, piridronate, pamidronate, zolendronate, pharmaceutically acceptable salts or esters thereof, and mixtures thereof.

47. A method according to claim 46 wherein said bisphosphonate is selected from the group consisting of alendronate, pharmaceutically acceptable salts or esters thereof, and mixtures thereof.

48. A method according to claim 47 wherein said pharmaceutically acceptable salt is alendronate monosodium trihydrate.

49. A method according to claim 46 wherein said bisphosphonate is selected from the group consisting of risedronate, pharmaceutically acceptable salts or esters thereof, and mixtures thereof.

50. A method according to claim 48 wherein said mammal is a human.

51. A method according to claim 50 wherein said dosing interval is once-weekly.

52. A method according to claim 51 wherein said bisphosphonate unit dosage comprises about 35 mg of alendronate monosodium trihydrate, on an alendronic acid active basis.

53. A method according to claim 50 wherein said dosing interval is twice-weekly.

54. A method according to claim 53 wherein said bisphosphonate unit dosage comprises about 17.5 mg of alendronate monosodium trihydrate, on an alendronic acid active basis.

55. A method according to claim 50 wherein said dosing interval is biweekly.

56. A method according to claim 55 wherein said bisphosphonate unit dosage comprises about 70 mg of alendronate monosodium trihydrate, on an alendronic acid active basis.

57. A method according to claim 50 wherein said dosing interval is twice-monthly.

58. A method according to claim 57 wherein said bisphosphonate unit dosage comprises about 70 mg of alendronate monosodium trihydrate, on an alendronic acid active basis.

59. A method according to any one of claims 29-58 wherein said histamine H2 receptor blocker or proton pump inhibitor is selected from the group consisting of cimetidine, famotidine, nizatidine, ranitidine, omprazole, and lansoprazole.
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