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Claims for Patent: 8,052,987

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Claims for Patent: 8,052,987

Title:Method of administering bisphosphonates
Abstract: The invention relates to bisphosphonates, in particular more potent N-bisphosphonates such as zoledronic acid and derivatives, and to methods of treatment using bisphosphonates. These bisphosphonates are used with satisfactory results for prolonged inhibition of bone resorption in conditions of abnormally increased bone turnover, e.g. osteoporosis, by intermittent administration, the periods between bisphosphonate administrations are longer than was previously considered appropriate, e.g. a dosing interval of at least about 6 months or less frequently.
Inventor(s): Horowitz; Zebulun D. (Basking Ridge, NJ), Richardson; Peter C. (Far Hills, NJ), Trechsel; Ulrich (Luzein, CH)
Assignee: Novartis Pharmaceuticals Corporation (East Hanover, NJ)
Application Number:10/311,942
Patent Claims: 1. A method for the treatment of conditions of abnormally increased bone turnover in a patient in need of such treatment which comprises intermittently administering an effective amount of 1-hydroxy-2-(imidazol-1-yl)ethane-1,1-diphosphonic acid or pharmaceutically acceptable salt thereof, or any hydrate thereof to the patient via intravenous administration, wherein the administrations of 1-hydroxy-2-(imidazol-1-yl)ethane-1,1-diphosphonic acid or pharmaceutically acceptable salt thereof, or any hydrate thereof is about once a year.

2. The method of claim 1 for the treatment of osteoporosis wherein the administrations of the 1-hydroxy-2-(imidazol-1-yl)ethane-1,1-diphosphonic acid or pharmaceutically acceptable salt thereof, or any hydrate thereof is about once a year.

3. The method of claim 1 wherein the 1-hydroxy-2-(imidazol-1-yl)ethane-1,1-diphosphonic acid or pharmaceutically acceptable salt thereof, or any hydrate thereof is in a unit dosage form adapted for parenteral administration which comprises from about 1 mg to about 10 mg of 1-hydroxy-2-(imidazol-1-yl)ethane-1,1-diphosphonic acid or pharmaceutically acceptable salt thereof, or any hydrate thereof.

4. The method of claim 3, wherein the unit dosage form comprises from about 1 mg to about 5 mg.

5. The method of claim 3, wherein the unit dosage form comprises from about 5 mg to about 10 mg.

6. The method of claim 4, wherein the unit dosage form comprises about 5 mg.

7. A method for the treatment of conditions of abnormally increased bone turnover in a patient in need of such treatment which comprises intermittently administering an effective amount of 1-hydroxy-2-(imidazol-1-yl)ethane-1,1-diphosphonic acid or pharmaceutically acceptable salt thereof, or any hydrate thereof to the patient via intravenous administration, wherein the administrations of 1-hydroxy-2-(imidazol-1-yl)ethane-1,1-diphosphonic acid or pharmaceutically acceptable salt thereof, or any hydrate thereof is about once every two years.

8. The method of claim 7 wherein the 1-hydroxy-2-(imidazol-1-yl)ethane-1,1-diphosphonic acid or pharmaceutically acceptable salt thereof, or any hydrate thereof is in a unit dosage form adapted for parenteral administration which comprises from about 1 mg to about 10 mg of 1-hydroxy-2-(imidazol-1-yl)ethane-1,1-diphosphonic acid or pharmaceutically acceptable salt thereof, or any hydrate thereof.

9. A method for the treatment of conditions of abnormally increased bone turnover in a patient in need of such treatment which comprises intermittently administering an effective amount of 1-hydroxy-2-(imidazol-1-yl)ethane-1,1-diphosphonic acid or pharmaceutically acceptable salt thereof, or any hydrate thereof to the patient via intravenous administration, wherein the administrations of 1-hydroxy-2-(imidazol-1-yl)ethane-1,1-diphosphonic acid or pharmaceutically acceptable salt thereof, or any hydrate thereof is less frequent than about once a year.
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