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Claims for Patent: 5,994,329

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Claims for Patent: 5,994,329

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)
Application Number:09/134,214
Patent Claims: 1. A method for inhibiting bone resorption in a mammal in need thereof comprising orally administering to said mammal a pharmaceutically effective amount of a bisphosphonate as a unit dosage 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, zoledronate, 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 from about 17.5 mg to about 70 mg of alendronate monosodium trihydrate, on an alendronic acid active basis.

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

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

11. A method according to claim 10 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.

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

13. A method according to claim 12 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.

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

15. A method according to claim 14 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.

16. A method for treating osteoporosis in a mammal in need thereof comprising orally administering to said mammal a pharmaceutically effective amount of a bisphosphonate as a unit dosage 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.

17. A method according to claim 16 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.

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

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

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

21. A method according to claim 19 wherein said mammal is a human.

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

23. A method according to claim 22 wherein said unit dosage of said bisphosphonate comprises about 70 mg of alendronate monosodium trihydrate, on an alendronic acid active basis.

24. A method according to claim 21 wherein said dosing interval is twice-weekly.

25. A method according to claim 24 wherein said unit dosage of said bisphosphonate comprises about 35 mg of alendronate monosodium trihydrate, on an alendronic acid active basis.

26. A method according to claim 21 wherein said dosing interval is biweekly.

27. A method according to claim 26, wherein said unit dosage of said bisphosphonate comprises about 140 mg of alendronate monosodium trihydrate, on an alendronic acid active basis.

28. A method according to claim 21 wherein said dosing interval is twice-monthly.

29. A method according to claim 28 wherein said unit dosage of said bisphosphonate comprises about 140 mg of alendronate monosodium trihydrate, on an alendronic acid active basis.

30. A method for preventing osteoporosis in a mammal in need thereof comprising orally administering to said mammal a pharmaceutically effective amount of a bisphosphonate as a unit dosage 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.

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, zoledronate, 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 bisphosphonate unit dosage comprises about 35 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 bisphosphonate unit dosage comprises about 17.5 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 40 wherein said bisphosphonate unit dosage comprises about 70 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 bisphosphonate unit dosage comprises about 70 mg of alendronate monosodium trihydrate, on an alendronic acid active basis.

44. A kit comprising at least one pharmaceutically effective unit dosage of a bisphosphonate for oral administration 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.
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