Claims for Patent: 7,803,770

Summary for Patent: 7,803,770

Title:	Method of treating osteoporosis comprising administration of PTHrP analog
Abstract:	The present invention provides a storage-stable composition containing a parathyroid hormone-related protein (PTHrP) and methods of using a PTHrP and the PTHrP compositions described herein to treat osteoporosis, to increase bone mass or to increase bone quality. The composition is storage stable, in sterile form, and in general may be stored at room temperature for at least several weeks to allow convenient parenteral administration to human patients.
Inventor(s):	Dey; Michael J. (Sandbach, GB), Mondoly; Nathalie (Le Chesnay, FR), Rigaud; Benedicte (Oulins, FR), Henderson; Bart (Belmont, MA), Lyttle; C. Richard (Bala Cynwyd, PA)
Assignee:	Radius Health, Inc. (Cambridge, MA) Ipsen Pharma S.A.S. (Boulogne-Billancourt, FR)
Application Number:	12/151,975
Patent Claims:	1. A method of treating osteoporosis comprising daily subcutaneous administration of a composition comprising 80 .mu.g of [Glu.sup.22,25, Leu.sup.23,28,31, Aib.sup.29, Lys.sup.26,30]hPTHrP(1-34)NH.sub.2 to a human in need thereof. 2. The method of claim 1, wherein the composition further comprises an effective amount of buffer to maintain the pH between 2 and 7. 3. The method of claim 1, wherein the buffer is selected from the group consisting of acetate, tartrate, phosphate and citrate buffers. 4. The method of claim 3, wherein the buffer is an acetate buffer. 5. The method of claim 4, wherein the buffer is acetic acid and sodium acetate. 6. The method of claim 2, wherein the pH is maintained between 3 and 6. 7. The method of claim 6, wherein the pH is maintained between 4 and 6. 8. The method of claim 7, wherein the pH is maintained between 4.5 and 5.6. 9. The method of claim 1, wherein the human is a post-menopausal woman. 10. The method according to claim 9 wherein the dose is 80 .mu.g and wherein said dose results in a plasma C.sub.max of [Glu.sup.22,25, Leu.sup.23,28,31, Aib.sup.29, Lys.sup.26,30]hPTHrP(1-34)NH.sub.2 from between 255.57 pg/mL and 364.3 pg/mL or from between 367.2 pg/mL and 504.8 pg/mL in said subject. 11. The method according to claim 9 wherein the dose is 80 .mu.g and wherein said dose results in a plasma T.sub.max of [Glu.sup.22,25, Leu.sup.23,28,31, Aib.sup.29, Lys.sup.26,30]hPTHrP(1-34)NH.sub.2 from between 0.251 hours and 1.01 hours, or from between 0.500 hours and 1.00 hours in said subject. 12. The method according to claim 9 wherein the dose is 80 .mu.g and wherein said dose results in a plasma t.sub.1/2 of [Glu.sup.22,25, Leu.sup.23,28,31, Aib.sup.29, LyS.sup.26,30] hPTHrP(1-34)NH.sub.2 from between 1.585 hours and 3.015 hours, or from between 1.265 hours and 2.115 hours in said subject. 13. The method according to claim 9 wherein the dose is 80 .mu.g and wherein said dose results in a plasma C.sub.max of [Glu.sup.22,25, Leu.sup.23,28,31, Aib.sup.29, Lys.sup.26,30] hPTHrP(1-34)NH.sub.2 from between 255.57 pg/mL and 364.3 pg/mL and a T.sub.max from between 0.251 hours and 1.01 hours, or a C.sub.max from between 367.2 pg/mL and 504.8 pg/mL and a T.sub.max from between 0.500 hours and 1.00 hours in said subject. 14. The method according to claim 9 wherein the dose is 80 .mu.g and wherein said dose results in a plasma C.sub.max of [Glu.sup.22,25, Leu.sup.23,28,31, Aib.sup.29, Lys.sup.26,30] hPTHrP(1-34)NH.sub.2 from between 255.57 pg/mL and 364.3 pg/mL and a T.sub.max from between 0.251 hours and 1.01 hours and a t.sub.1/2 of between 1.585 hours and 3.015 hours, or a C.sub.max from between 367.2 pg/mL and 504.8 pg/mL and a T.sub.max from between 0.500 hours and 1.00 hours and a t.sub.1/2 of between 1.265 hours and 2.115 hours in said subject.