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Claims for Patent: 8,324,189

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Claims for Patent: 8,324,189

Title:Use of zolendronate for the manufacture of a medicament for the treatment of bone metabolism diseases
Abstract: A method of intravenously administering a bisphosphonate to a patient in need of bisphosphonate treatment comprising intravenously administering 4 mg of 2-(imidazol-1yl)-1-hydroxyethane-1,1-diphosphonic acid (zoledronic acid) or a pharmaceutically acceptable salt thereof over a period of 15 minutes to a patient in need of said treatment.
Inventor(s): Galli; Bruno (Seltisberg, CH), Schran; Horst F (Morristown, NJ), Seaman; John J (New Hope, PA)
Assignee: Novartis Pharmaceuticals Corporation (East Hanover, NJ)
Application Number:11/594,410
Patent Claims: 1. A method of treatment of bone metabolism diseases, said method comprising intravenous administration of 4 mg of 2-(imidazol-1yl)-1-hydroxyethane-1,1-diphosphonic acid or a pharmaceutically acceptable salt thereof in an infusion solution volume of from about 5 up to about 200 ml over a period of 15 minutes to a patient in need of said treatment, wherein said intravenous administration improves renal safety.

2. The method according to claim 1, wherein said bone metabolism disease is tumour induced hypercalcemia.

3. The method according to claim 1, wherein said infusion volume is from about 50 to about 100 ml.

4. The method according to claim 1, wherein said infusion volume is about 100 ml.

5. The method according to claim 1, wherein the 2(imidazol-1yl)-1-hydroxyethane-1,1-diphosphonic acid is in the form of a pharmaceutically acceptable salt having one acidic hydrogen and one pharmaceutically acceptable cation in each of the phosphonic acid groups.

6. The method according to claim 5, wherein said pharmaceutically acceptable cation is sodium.

7. A method of treatment of bone metastases, said method comprising intravenous administration of 4 mg of 2-(imidazol-1yl)-1-hydroxyethane-1,1-diphosphonic acid or a pharmaceutically acceptable salt thereof in an infusion solution volume of from about 5 up to about 200 ml over a period of 15 minutes to a patient in need of said treatment, wherein said intravenous administration improves renal safety.

8. The method according to claim 7, wherein said infusion volume is from about 50 to about 100 ml.

9. The method according to claim 7, wherein said infusion volume is about 100 ml.

10. The method according to claim 7, wherein the 2-(imidazol-1yl)-1-hydroxyethane-1,1-diphosphonic acid is in the form of a pharmaceutically acceptable salt having one acidic hydrogen and one pharmaceutically acceptable cation in each of the phosphonic acid groups.

11. The method according to claim 10, wherein said pharmaceutically acceptable cation is sodium.

12. A method of treatment of multiple myeloma, said method comprising intravenous administration of 4 mg of 2-(imidazol-1yl)-1-hydroxyethane-1,1-diphosphonic acid or a pharmaceutically acceptable salt thereof in an infusion solution volume of from about 5 up to about 200 ml over a period of 15 minutes to a patient in need of said treatment, wherein the intravenous administration improves renal safety.

13. The method according to claim 12, wherein said infusion volume is from about 50 to abut 100 ml.

14. The method according to claim 12, wherein said infusion volume is about 100 ml.

15. The method according to claim 12, wherein the 2-(imidazol-1yl)-1-hydroxyethane-1,1-diphosphonic acid is in the form of a pharmaceutically acceptable salt having one acidic hydrogen and one pharmaceutically acceptable cation in each of the phosphonic acid groups.

16. The method according to claim 15, wherein said pharmaceutically acceptable cation is sodium.

17. A method of treatment of bone metabolism diseases, said method comprising intravenous administration of 4 mg of 2-(imidazol-1yl)-1-hydroxyethane-1,1-diphosphonic acid or a pharmaceutically acceptable salt thereof in an infusion solution volume of from about 5 up to about 200 ml over a period of 15 minutes to a patient in need of said treatment, wherein said intravenous administration reduces incidence of renal toxicity.

18. The method according to claim 17, wherein said bone metabolism disease is tumour induced hypercalcemia.

19. The method according to claim 17, wherein said infusion volume is from about 50 to about 100 ml.

20. The method according to claim 17, wherein said infusion volume is about 100 ml.

21. The method according to claim 17, wherein the 2(imidazol-1yl)-1-hydroxyethane-1,1-diphosphonic acid is in the form of a pharmaceutically acceptable salt having one acidic hydrogen and one pharmaceutically acceptable cation in each of the phosphonic acid groups.

22. The method according to claim 21, wherein said pharmaceutically acceptable cation is sodium.

23. A method of treatment of bone metastases, said method comprising intravenous administration of 4 mg of 2-(imidazol-1yl)-1-hydroxyethane-1,1-diphosphonic acid or a pharmaceutically acceptable salt thereof in an infusion solution volume of from about 5 up to about 200 ml over a period of 15 minutes to a patient in need of said treatment, wherein said intravenous administration reduces incidence of renal toxicity.

24. The method according to claim 23, wherein said infusion volume is from about 50 to about 100 ml.

25. The method according to claim 23, wherein said infusion volume is about 100 ml.

26. The method according to claim 23, wherein the 2-(imidazol-1yl)-1-hydroxyethane-1,1-diphosphonic acid is in the form of a pharmaceutically acceptable salt having one acidic hydrogen and one pharmaceutically acceptable cation in each of the phosphonic acid groups.

27. The method according to claim 26, wherein said pharmaceutically acceptable cation is sodium.

28. A method of treatment of multiple myeloma, said method comprising intravenous administration of 4 mg of 2-(imidazol-1yl)-1-hydroxyethane-1,1-diphosphonic acid or a pharmaceutically acceptable salt thereof in an infusion solution volume of from about 5 up to about 200 ml over a period of 15 minutes to a patient in need of said treatment, wherein the intravenous administration reduces incidence of renal toxicity.

29. The method according to claim 28 wherein said infusion volume is from about 50 to about 100 ml.

30. The method according to claim 28, wherein said infusion volume is about 100 ml.

31. The method according to claim 28, wherein the 2-(imidazol-1yl)-1-hydroxyethane-1,1-diphosphonic acid is in the form of a pharmaceutically acceptable salt having one acidic hydrogen and one pharmaceutically acceptable cation in each of the phosphonic acid groups.

32. The method according to claim 31, wherein said pharmaceutically acceptable cation is sodium.
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