Claims for Patent: 6,132,774

Summary for Patent: 6,132,774

Title:	Therapeutic combinations comprising a selective estrogen receptor modulator and parathyroid hormone
Abstract:	This invention is directed to pharmaceutical combination compositions and methods comprising (-)-cis-6-phenyl-5-(4-(2-pyrrolidin-1-yl-ethoxy)-phenyl)-5,6,7,8-tetrahydr onaphthalene-2-ol or a pharmaceutically acceptable salt thereof and parathyroid hormone or a biologically active fragment thereof, methods of using such compositions and kits containing such compositions. The compositions are useful for treating musculoskeletal frailty, including osteoporosis, osteoporotic fracture, low bone mass and frailty.
Inventor(s):	Ke; HuaZhu (Ledyard, CT), Thompson; David D. (Gales Ferry, CT)
Assignee:	Pfizer Inc. (New York, NY)
Application Number:	09/424,010
Patent Claims:	1. A pharmaceutical composition comprising synergistic effective amounts of: a. a first compound, said first compound being (-)-cis-6-phenyl-5-(4-(2-pyrrolidin-1-yl-ethoxy)-phenyl)-5,6,7,8-tetrahydr onaphthalene-2-ol or a pharmaceutically acceptable salt thereof; and b. a second compound, said second compound being parathyroid hormone or a biologically active fragment thereof. 2. A pharmaceutical composition of claim 1 additionally comprising a pharmaceutical carrier or diluent. 3. A pharmaceutical composition of claim 1 wherein said first compound is (-)-cis-6-phenyl-5-(4-(2-pyrrolidin-1-yl-ethoxy)-phenyl)-5,6,7,8-tetrahydr onaphthalene-2-ol D-tartrate and said second compound is parathyroid hormone 1-34. 4. A pharmaceutical composition of claim 1 wherein said first compound is (-)-cis-6-phenyl-5-(4-(2-pyrrolidin-1-yl-ethoxy)-phenyl)-5,6,7,8-tetrahydr onaphthalene-2-ol D-tartrate and said second compound is parathyroid hormone 1-38. 5. A method for treating a mammal suffering from musculoskeletal frailty comprising administering to said mammal a pharmaceutical composition of claim 1. 6. A method of claim 5 wherein said first compound is (-)-cis-6-phenyl-5-(4-(2-pyrrolidin-1-yl-ethoxy)-phenyl)-5,6,7,8-tetrahydr onaphthalene-2-ol D-tartrate and said second compound is parathyroid hormone 1-34. 7. A method of claim 5 wherein said first compound is (-)-cis-6-phenyl-5-(4-(2-pyrrolidin-1-yl-ethoxy)-phenyl)-5,6,7,8-tetrahydr onaphthalene-2-ol D-tartrate and said second compound is parathyroid hormone 1-38. 8. A method of claim 5 wherein said mammal is suffering from osteoporosis. 9. A method of claim 5 wherein said mammal is suffering from osteotomy, childhood idiopathic bone or bone loss associated with periodontitis. 10. The method of claim 5 wherein bone fracture, bone healing following facial reconstruction, maxillary reconstruction or mandibular reconstruction is treated, vertebral synostosis is induced or long bone extension is enhanced, the healing rate of a bone graft is enhanced or prosthetic ingrowth is enhanced. 11. The method of claim 10 wherein a bone fracture is treated in a human. 12. A method of claim 8 wherein osteoporosis is treated in a human. 13. A method for treating a mammal suffering from musculoskeletal frailty comprising administering to said mammal synergistic effective amounts of a. a first compound, said first compound being (-)-cis-6-phenyl-5-(4-(2-pyrrolidin-1-yl-ethoxy)-phenyl)-5,6,7,8-tetrahydr onaphthalene-2-ol or a pharmaceutically acceptable salt thereof; and b. a second compound, said second compound being parathyroid hormone or a biologically active fragment thereof. 14. A method of claim 13 wherein the first compound and the second compound are administered substantially simultaneously. 15. A method of claim 13 wherein the second compound is administered for a period of from about three months to about three years. 16. A method of claim 15 followed by administration of the first compound for a period of from about three months to about three years without the administration of the second compound during the period of from about three months to about three years. 17. A method of claim 15 followed by administration of the first compound for a period greater than about three years without the administration of the second compound during the greater than about three year period. 18. A method of claim 13 wherein said mammal is suffering from osteoporosis. 19. A method of claim 18 wherein said mammal is a human. 20. A method of claim 13 wherein said mammal is suffering from osteotomy, childhood idiopathic bone loss or bone loss associated with periodontitis. 21. The method of claim 13 wherein bone fracture, bone healing following facial reconstruction, maxillary reconstruction or mandibular reconstruction is treated, vertebral synostosis is induced or long bone extension is enhanced, the healing rate of a bone graft is enhanced or prosthetic ingrowth is enhanced. 22. The method of claim 21 wherein a bone fracture is treated in a human. 23. A kit comprising synergistic effective amounts of: a. (-)-cis-6-phenyl-5-(4-(2-pyrrolidin-1-yl-ethoxy)-phenyl)-5,6,7,8-tetrahydr onaphthalene-2-ol or a pharmaceutically acceptable salt thereof and a pharmaceutically acceptable carrier or diluent in a first unit dosage form; b. parathyroid hormone or a biologically active fragment thereof and a pharmaceutically acceptable carrier or diluent in a second unit dosage form; and c. a container. 24. A kit of claim 23 wherein said first unit dosage form comprises (-)-cis-6-phenyl-5-(4-(2-pyrrolidin-1-yl-ethoxy)-phenyl)-5,6,7,8-tetrahydr onaphthalene-2-ol D-tartrate and said second unit dosage form comprises parathyroid hormone 1-34. 25. A kit of claim 23 wherein said first unit dosage form comprises (-)-cis-6-phenyl-5-(4-(2-pyrrolidin-1-yl-ethoxy)-phenyl)-5,6,7,8-tetrahydr onaphthalene-2-ol D-tartrate and said second unit dosage form comprises parathyroid hormone 1-38.

Details for Patent 6,132,774

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Nps Pharmaceuticals, Inc.	NATPARA	parathyroid hormone	For Injection	125511	01/23/2015		2018-06-16