Methods of treating pain with compositions comprising RANK/RANKL antagonists and related compounds

1. A method of treating or relieving osteoarthritis pain, low back pain, or pain from complex regional pain syndrome in a mammal in need thereof, comprising administering a pharmaceutical composition comprising:

a) antibody means for antagonizing RANK/RANKL binding; and

b) one or more physiologically acceptable carriers, excipients or diluents.

2. The method of claim 1 , wherein the antibody means for antagonizing RANK/RANKL binding comprises an anti-RANKL antibody.

3. The method of claim 1 , wherein the antibody means for antagonizing RANK/RANKL binding competes with denosumab for binding to RANKL.

4. The method of claim 1 , wherein the antibody means is a monoclonal antibody.

5. The method of claim 4 , wherein the monoclonal antibody is a human antibody, a humanized antibody, or a chimeric antibody.

6. The method of claim 5 , wherein the monoclonal antibody is a human antibody.

7. The method of claim 5 , wherein the monoclonal antibody is a humanized antibody.

8. The method of claim 1 , wherein the antibody means for antagonizing RANK/RANKL binding comprises a RANKL-binding fragment.

9. The method of claim 8 , wherein the RANKL-binding fragment is a Fab, a Fab′, a F(ab′)2, a Fv fragment, a diabody, a linear antibody, or a single-chain antibody molecule.

10. The method of claim 9 , wherein the RANKL-binding fragment is a single-chain antibody molecule.

11. The method of claim 1 , wherein the antibody means for antagonizing RANK/RANKL binding partially or fully blocks, inhibits, or neutralizes a biological activity of RANKL.

12. The method of claim 1 , wherein the antibody means for antagonizing RANK/RANKL binding comprises a) a heavy chain comprising CDR1, CDR2, and CDR3 of SEQ ID NO: 3; and b) a light chain comprising CDR1, CDR2, and CDR3 of SEQ ID NO: 4.

13. The method of claim 1 , wherein the mammal is a human.

14. The method of claim 1 , wherein about 0.05 mg/kg to about 3 mg/kg of the antibody means is administered to the mammal within a four week period.

15. The method of claim 14 , where about 0.1 mg/kg to about 20 mg/kg of the antibody means is administered.

16. The method of claim 1 , wherein the antibody means is administered no more than once a week.

17. The method of claim 1 , wherein the antibody means is administered daily, weekly, monthly, every three months, every six months, or every year.

18. The method of claim 1 , wherein the method is a method of relieving osteoarthritis pain.

19. The method of claim 18 , wherein the osteoarthritis pain affects a knee.

20. The method of claim 1 , wherein the method is a method of relieving pain from complex regional pain syndrome.

21. The method of claim 1 , wherein the method is a method of relieving low back pain.

22. The method of claim 1 , wherein the mammal experiences pain relief within about three months after the antibody means is first administered.

23. The method of claim 1 , wherein the mammal experiences pain relief for at least 24 hours.

24. The method of claim 1 , wherein the excipient comprises polyethylene glycol or a metal ion.

25. The method of claim 1 , wherein the carrier comprises polyacetic acid, polyglycolic acid, a hydrogel, dextran, a liposome, a microemulsion, a micelle, a unilamellar vesicle, a multilamellar vesicle, an erythrocyte ghost, or a spheroblast.

26. The method of claim 1 , wherein the diluent comprises sterile water, sucrose solution, neutral buffered saline, or saline mixed with conspecific serum albumin.

27. The method of claim 1 , wherein the excipient comprises a buffer, an antioxidant, ascorbic acid, an amino acid, a polypeptide of less than about 10 residues, a protein, a carbohydrate, glucose, sucrose, dextrin, a chelator, EDTA, or glutathione.

28. The method of claim 25 , wherein the liposome comprises monoglycerides, diglycerides, cholesterols, sulfatides, lysolecithins, phospholipids, saponins, or bile acids.