Claims for Patent: 5,869,473

Summary for Patent: 5,869,473

Title:	Method for treating and preventing hyperparathyroidism
Abstract:	A method for reducing or preventing elevated blood parathyroid hormone level in a human being suffering from hyperparathyroidism by administering a sufficient amount of 1.alpha.-OH vitamin D.sub.2, 1.alpha.-OH vitamin D.sub.4 or 1.alpha.,24(R)-(OH).sub.2 vitamin D.sub.4.
Inventor(s):	Knutson; Joyce C. (Madison, WI), Mazess; Richard B. (Madison, WI), Bishop; Charles W. (Madison, WI)
Assignee:	Bone Care International, Inc. (Madison, WI)
Application Number:	08/907,659
Patent Claims:	1. A method for lowering or maintaining lowered serum parathyroid hormone in human patients suffering from hyperparathyroidism, comprising: administering to said patients an effective amount of a vitamin D analog to lower and maintain lowered serum parathyroid hormone levels, said analog comprising formula (I): ##STR2## wherein A.sup.1 and A.sup.2 are either hydrogen or taken together, form a carbon-carbon double bond between C-22 and C-23; and R.sup.1 is hydrogen or hydroxyl provided that when A.sup.1 and A.sup.2 are a double bond, R.sup.1 is hydrogen. 2. The method according to claim 1, wherein said analog of formula (I) is 1.alpha.-OH-vitamin D.sub.2 ; 1.alpha.-OH-vitamin D.sub.4 ; or 1.alpha.,24(R)-(OH).sub.2 -vitamin D.sub.4. 3. The method of claim 2 wherein said analog comprises a weekly dosage of about 1 .mu.g to about 100 .mu.g. 4. The method of claim 1 wherein said analog, in solution, in a liquid vehicle ingestible by and nontoxic to said patients, is administered orally in encapsulated form. 5. The method of claim 1 wherein said analog is co-administered with a calcium phosphate binder. 6. The method of claim 1 wherein said analog is administered in combination with at least one agent characterized by said agent's ability to reduce loss of bone mass, or bone mineral content in patients. 7. The method of claim 6 wherein said agent is other vitamin D compounds, conjugated estrogens, sodium fluorides, biphosphonates, cobalamin, pertussin toxin or boron. 8. The method of claim 1, wherein said administration of said analog is parenteral. 9. The method of claim 8 wherein said administration is by subcutaneous, intramuscular, or intravenous injection, nasopharyngeal or mucosal absorption, or transdermal absorption. 10. The method of claim 1 wherein said administration of said analog is nonparenteral. 11. A method for achieving an effect in a patient comprising administering to the patient an effective amount of a vitamin D analog of formula (I): ##STR3## wherein A.sup.1 and A.sup.2 are either hydrogen or taken together, form a carbon-carbon double bond between C-22 and C-23; and R.sup.1 is hydrogen or hydroxyl provided that when A.sup.1 and A.sup.2 are a double bond, R.sup.1 is hydrogen and wherein the effect is lowering or maintaining lowered serum parathyroid hormone levels, in a patient in need thereof and thus decreasing loss of bone mass or bone mineral content. 12. A method of treating a human to alleviate or prevent the pathological effects of hyperparathyroidism, wherein the method comprises administering to the human in need thereof a vitamin D analog selected from the group consisting of 1.alpha.-OH-vitamin D.sub.2 ; 1.alpha.-OH-vitamin D.sub.4 ; and 1.alpha.,24(R)-(OH).sub.2 -vitamin D.sub.4 wherein said analog is administered to the human in an amount sufficient to lower or maintain lowered serum parathyroid hormone levels in said human to thereby alleviate or prevent the effects. 13. The method of claim 12, wherein said serum parathyroid hormone levels are measured by blood serum level of parathyroid hormone over time after ingestion. 14. A method for lowering or maintaining lowered serum parathyroid hormone in human patients suffering from secondary hyperparathyroidism, comprising: administering to said patients an effective amount of a vitamin D analog to lower and maintain lowered serum parathyroid hormone levels, said analog comprising formula (I): ##STR4## wherein A.sup.1 and A.sup.2 are either hydrogen or a carbon-carbon double bond between C-22 and C-23; and R.sup.1 is hydrogen or hydroxyl provided that when A.sup.1 and A.sup.2 are a double bond, R.sup.1 is hydrogen.

Details for Patent 5,869,473

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Nps Pharmaceuticals, Inc.	NATPARA	parathyroid hormone	For Injection	125511	01/23/2015		2008-08-02