Claims for Patent: 7,749,543

Summary for Patent: 7,749,543

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 (Molndal, SE), Sjogren; Sven (Molndal, SE)
Assignee:	NPS Pharmaceuticals, Inc. (Bedminster, NJ)
Application Number:	12/351,558
Patent Claims:	1. A method for the treatment of osteoporosis in humans comprising: administering to said human an effective amount of parathyroid hormone during a period of approximately 6 to 24 months; and after the administration of said parathyroid hormone has been terminated, optionally administering a bone resorption inhibitor during a period of approximately 6 to 36 months. 2. A method according to claim 1, wherein the parathyroid hormone is selected from (a) full-length parathyroid hormone; (b) biologically active variants of full-length parathyroid hormone; (c) biologically active parathyroid hormone fragments; and (d) biologically active variants of parathyroid hormone fragments. 3. A method according to claim 1, wherein administering to said human an effective amount of parathyroid hormone, consists of administering a human PTH (1-84) during a period of approximately 6 to 24 months. 4. A method according to claim 1, wherein administering to said human an effective amount of parathyroid hormone, consists of administering once daily a human PTH (1-84) dose of 50 .mu.g to 100 .mu.g during a period of approximately 6 to 24 months. 5. A method according to claim 1, wherein the optionally administering a bone resorption inhibitor comprises administering a bone resorption inhibitor selected from the group consisting of bisphosphonate, a selective estrogen receptor modulator, calcitonin, a vitamin D analog, and a calcium salt. 6. A method according to claim 1, wherein the said human is a post-menopausal female. 7. A method for the enhancement of bone mineral density in a human needing enhancement of bone density, the method comprising: optionally administering, to a human who has already been subject to treatment with parathyroid hormone during a period of approximately 6 to 24 months, after the administration of parathyroid hormone has been terminated, an effective amount of a bone resorption inhibitor during a period of approximately 6 to 36 months. 8. A method according to claim 7, wherein the optionally administering a bone resorption inhibitor comprises administering a bone resorption inhibitor selected from the group consisting of bisphosphonate, a selective estrogen receptor modulator, calcitonin, a vitamin D analog, and a calcium salt. 9. A method according to claim 7, wherein the said human is a post-menopausal female.

Details for Patent 7,749,543

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Nps Pharmaceuticals, Inc.	NATPARA	parathyroid hormone	For Injection	125511	01/23/2015		2017-06-19