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Last Updated: March 28, 2024

Claims for Patent: 8,153,588


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Summary for Patent: 8,153,588
Title:Methods useful in the treatment of bone resorption diseases
Abstract: The invention relates to a combined pharmaceutical preparation comprising parathyroid hormone and a bone resorption inhibitor, said preparation being adapted for (a) the administration of parathyroid hormone during a period of approximately 6 to 24 months; (b) after the administration of parathyroid hormone has been terminated, the administration of a bone resorption inhibitor during a period of approximately 12 to 36 months.
Inventor(s): Dietrich; John (Etobicoke, CA), Ljunghall; Sverker (Uppsala, SE), Sjogren; Sven (Billdal, SE)
Assignee: NPS Pharmaceuticals, Inc. (Bedminster, NJ)
Application Number:12/822,089
Patent Claims:1. A pharmaceutical preparation for sequential administration of an anabolic agent and a bone resorption inhibitor, the pharmaceutical preparation comprising a full-length parathyroid hormone and a bone resorption inhibitor, wherein the full-length parathyroid hormone is provided separate from the bone resorption inhibitor, said preparation being adapted for (a) the administration of the full-length parathyroid hormone during a period of approximately 6 to 24 months; and (b) after the administration of said full-length parathyroid hormone has been terminated, the administration of the bone resorption inhibitor during a period of approximately 6 to 36 months.

2. A pharmaceutical preparation according to claim 1, adapted for said administration of full-length parathyroid hormone for approximately 12 to 24 months.

3. A pharmaceutical preparation according to claim 2, adapted for said administration of full-length parathyroid hormone for approximately 18 months.

4. A pharmaceutical preparation according to claim 1 adapted for said administration of bone resorption inhibitor for approximately 12 to 36 months.

5. A pharmaceutical preparation according to claim 4, adapted for said administration of bone resorption inhibitor for approximately 12 to 18 months.

6. A pharmaceutical preparation according to claim 5, adapted for said administration of bone resorption inhibitor for approximately 12 months.

7. A preparation according to claim 1 wherein the said bone resorption inhibitor is a bisphosphonate.

8. A preparation according to claim 7 wherein the said bisphosphonate is alendronate.

9. A preparation according to claim 1 wherein the said bone resorption inhibitor is a substance with estrogen-like effect.

10. A preparation according to claim 9 wherein the said substance with estrogen-like effect is estrogen.

11. A preparation according to claim 1 wherein the said bone resorption inhibitor is a selective estrogen receptor modulator.

12. A preparation according to claim 11 wherein the said selective estrogen receptor modulator is selected from the group consisting of raloxifene, tamoxifene, droloxifene, toremifene, idoxifene, or levormeloxifene.

13. A preparation according to claim 1 wherein the said bone resorption inhibitor is a calcitonin-like substance.

14. A preparation according to claim 13 wherein the said calictonin-like substance is calcitonin.

15. A preparation according to claim 1 wherein the said bone resorption inhibitor is a vitamin D analog.

16. A preparation according to claim 1 wherein the said bone resorption inhibitor is a calcium salt.

17. A method of manufacturing a pharmaceutical preparation for the treatment of bone-related disorders, wherein the pharmaceutical preparation is a multi-component pharmaceutical preparation for sequential administration of an anabolic agent and a bone resorption inhibitor and the method comprises: providing a full-length parathyroid hormone as the anabolic agent; preparing a first pharmaceutical preparation comprising the full-length parathyroid hormone, said first pharmaceutical preparation being adapted for administration of the full-length parathyroid hormone during a period of approximately 6 to 24 months; and preparing a second pharmaceutical preparation, the second pharmaceutical preparation comprising the bone resorption inhibitor and being adapted for administration of the bone resorption inhibitor during a period of approximately 12 to 36 months after the administration of the full-length parathyroid hormone has been terminated.

18. The method according to claim 17, wherein said first pharmaceutical preparation is adapted for administration of full-length parathyroid hormone for approximately 12 to 24 months.

19. The method according to claim 18 wherein said first pharmaceutical preparation is adapted for administration of full-length parathyroid hormone for approximately 18 months.

20. The method according to claim 17, wherein said first pharmaceutical preparation is adapted for administration of bone resorption inhibitor for approximately 12 to 36 months.

21. The method according to claim 20, wherein said second pharmaceutical preparation is adapted for said administration of the bone resorption inhibitor for approximately 12 to 18 months.

22. The method according to claim 21, wherein said second pharmaceutical preparation is adapted for said administration of the bone resorption inhibitor for approximately 12 months.

23. The method according to claim 17 wherein the bone resorption inhibitor is at least one of the group consisting of a bisphosphonate, a substance with estrogen-like effect, a selective estrogen receptor modulator, a calcitonin-like substance, a vitamin D analog, and a calcium salt.

24. The method according to claim 17 wherein the multi-component pharmaceutical preparation is adapted for the treatment of osteoporosis.

25. A method for treating bone-related diseases which comprises administering to a mammal, including man, in need of such treatment an effective amount of a pharmaceutical preparation according to claim 1, the method comprising (a) administering the full-length parathyroid hormone during a period of approximately 6 to 24 months; and (b) after the administration of said full-length parathyroid hormone has been terminated, administering the bone resorption inhibitor during a period of approximately 6 to 36 months.

26. A method for treating bone-related diseases which comprises administering to a patient an effective amount of a bone resorption inhibitor for a period of approximately 6 to 36 months, wherein said administration of the bone resorption inhibitor is made after the patient has been treated with full-length parathyroid hormone for a period of 6 to 24 months and after treatment with full-length parathyroid hormone has terminated.

27. A method of treating bone-related diseases according to claim 25, wherein said full-length parathyroid hormone is administered to the patient for approximately 12 to 24 months.

28. A method of treating bone-related diseases according to claim 27, wherein said full-length parathyroid hormone is administered to the patient for approximately 18 months.

29. A method of treating bone-related diseases according to claim 25, wherein said bone resorption inhibitor is administered to the patient for approximately 12 to 36 months.

30. A method for treating bone-related diseases according to claim 29, wherein said bone resorption inhibitor is administered to the patient for approximately 12 to 18 months.

31. A method for treating bone-related diseases according to claim 30, wherein said bone resorption inhibitor is administered to the patient for approximately 12 months.

32. The method according to claim 25 wherein the bone resorption inhibitor is at least one of the group consisting of a bisphosphonate, a substance with estrogen-like effect, a selective estrogen receptor modulator, a calcitonin-like substance, a vitamin D analog, and a calcium salt.

33. The method according to claim 25, wherein the bone-related disease is osteoporosis.

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