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Details for Patent: 6,333,316

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Details for Patent: 6,333,316

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 carrying out the therapeutic methods disclosed herein.
Inventor(s): Daifotis; Anastasia G. (Westfield, NJ), Santora, II; Arthur C. (Watchung, NJ), Yates; A. John (Westfield, NJ)
Assignee: Merck & Co., Inc. (Rahway, NJ)
Filing Date:Aug 18, 1999
Application Number:09/376,314
Claims:1. A method for inhibiting bone resorption in a mammal, in need thereof, comprising sequentially orally administering to said mammal, in need thereof 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.

2. A method according to claim 1 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.

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

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

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

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

7. A method according to claim 5 wherein said mammal is a human.

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

9. A method according to claim 8 wherein said unit dosage of said bisphosphonate comprises from about 17.5 mg to about 70 mg of alendronate monosodium trihydrate, on an alendronic acid active basis.

10. A method according to claim 9 wherein said unit dosage of said bisphosphonate comprises about 70 mg of alendronate monosodium trihydrate, on an alendronic acid active basis.

11. A method according to claim 7 wherein said dosing interval is twice-weekly.

12. A method according to claim 11 wherein said unit dosage of said bisphosphonate comprises from about 8.75 mg to about 35 mg of alendronate monosodium trihydrate, on an alendronic acid active basis.

13. A method according to claim 7 wherein said dosing interval is biweekly.

14. A method according to claim 13 wherein said unit dosage of said bisphosphonate comprises from about 35 mg to about 140 mg of alendronate monosodium trihydrate, on an alendronic acid active basis.

15. A method according to claim 7 wherein said dosing interval is twice-monthly.

16. A method according to claim 15 wherein said unit dosage of said bisphosphonate comprises about 35 mg to about 140 mg of alendronate monosodium trihydrate, on an alendronic acid active basis.

17. A method for treating osteoporosis in a mammal in need thereof 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.

18. A method according to claim 17 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.

19. A method according to claim 18 wherein said bisphosphonate is selected from the group consisting of alendronate, cimadronate, clodronate, tiludronate, etidronate, ibandronate, risedronate, piridronate, pamidronate, zoledronate, pharmaceutically acceptable salts or esters thereof, and mixtures thereof.

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

21. A method according to claim 20 wherein said pharmaceutically acceptable salt is alendronate monosodium trihydrate.

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

23. A method according to claim 21 wherein said mammal is a human.

24. A method according to claim 23 wherein said dosing interval is once-weekly.

25. A method according to claim 24 wherein said unit dosage of said bisphosphonate comprises about 70 mg of alendronate monosodium trihydrate, on an alendronic acid active basis.

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

27. A method according to claim 26 wherein said unit dosage of said bisphosphonate comprises about 35 mg of alendronate monosodium trihydrate, on an alendronic acid active basis.

28. A method according to claim 23 wherein said dosing interval is biweekly.

29. A method according to claim 27 wherein said unit dosage of said bisphosphonate comprises about 140 mg of alendronate monosodium trihydrate, on an alendronic acid active basis.

30. A method according to claim 23 wherein said dosing interval is twice-monthly.

31. A method according to claim 30 wherein said unit dosage of said bisphosphonate comprises about 140 mg of alendronate monosodium trihydrate, on an alendronic acid active basis.

32. A method for preventing osteoporosis in a mammal, in need thereof, comprising sequentially orally administering to said mammal, in need thereof 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.

33. A method according to claim 32 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.

34. A method according to claim 33 wherein said bisphosphonate is selected from the group consisting of alendronate, cimadronate, clodronate, tiludronate, etidronate, ibandronate, risedronate, piridronate, pamidronate, zoledronate, pharmaceutically acceptable salts or esters thereof, and mixtures thereof.

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

36. A method according to claim 35 wherein said pharmaceutically acceptable salt is alendronate monosodium trihydrate.

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

38. A method according to claim 36 wherein said mammal is a human.

39. A method according to claim 38 wherein said dosing interval is once-weekly.

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

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

42. A method according to claim 41 wherein said bisphosphonate unit dosage comprises about 17.5 mg of alendronate monosodium trihydrate, on an alendronic acid active basis.

43. A method according to claim 38 wherein said dosing interval is biweekly.

44. A method according to claim 38 wherein said bisphosphonate unit dosage comprises about 70 mg of alendronate monosodium trihydrate, on an alendronic acid active basis.

45. A method according to claim 38 wherein said dosing interval is twice-monthly.

46. A method according to claim 45 wherein said bisphosphonate unit dosage comprises about 70 mg of alendronate monosodium trihydrate, on an alendronic acid active basis.

47. A method according to any of claims 1-46 wherein said histamine H2 receptor blocker or proton pump inhibitor is selected from the group consisting of cimetidine, famotidine, nizatidine, ranitidine, omeprazole, and lansoprazole.

48. A kit comprising, comprising:

(a) at least one pharmaceutically effective unit dosage of a bisphosphonate for oral administration, and

(b) at least one pharmaceutically effective unit dosage of a histamine H2 receptor blocker or a proton pump inhibitor.

49. A kit according to claim 48 wherein said bisphosphonate is selected from the group consisting of alendronate, cimadronate, clodronate, tiludronate, etidronate, ibandronate, risedronate, piridronate, pamidronate, zoledronate, pharmaceutically acceptable salts or esters thereof, and mixtures thereof.

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

51. A kit according to claim 50 wherein said pharmaceutically acceptable salt is alendronate monosodium trihydrate.

52. A kit according to claim 51 wherein said histamine H2 receptor blocker or proton pump inhibitor is selected from the group consisting of cimetidine, famotidine, nizatidine, ranitidine, omeprazole, and lansoprazole.

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

54. A kit according to claim 53 wherein said histamine H2 receptor blocker or proton pump inhibitor is selected from the group consisting of cimetidine, famotidine, nizatidine, ranitidine, omeprazole, and lansoprazole.

55. A kit according to any of claims 48-54 wherein said unit dosage of said bisphosphonate comprises from about 1.5 to about 6000 .mu.g/kg body weight.

56. A kit according to claim 55 wherein said unit dosage of said bisphosphonate comprises from about 10 to about 2000 .mu.g/kg body weight.

57. A kit according to claim 50 wherein said unit dosage comprises from about 8.75 to about 140 mg of said bisphosphonate on an alendronic acid active basis.

58. A kit according to claim 57 wherein said unit dosage comprises about 35 mg of said bisphosphonate on an alendronic acid active basis.

59. A kit according to claim 57 wherein said unit dosage comprises about 70 mg of said bisphosphonate on an alendronic acid active basis.

60. A kit according to claim 51 wherein said unit dosage comprises from about 8.75 to about 140 mg of said bisphosphonate on an alendronic acid active basis.

61. A kit according to claim 60 wherein said unit dosage comprises about 35 mg of said bisphosphonate on an alendronic acid active basis.

62. A kit according to claim 60 wherein said unit dosage comprises about 70 mg of said bisphosphonate on an alendronic acid active basis.

63. A kit according to claim 52 wherein said unit dosage comprises from about 8.75 to about 140 mg of said bisphosphonate on an alendronic acid active basis.

64. A kit according to claim 63 wherein said unit dosage comprises about 35 mg of said bisphosphonate on an alendronic acid active basis.

65. A kit according to claim 63 wherein said unit dosage comprises about 70 mg of said bisphosphonate on an alendronic acid active basis.
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