Claims for Patent: 6,524,788

Summary for Patent: 6,524,788

Title:	Methods for monitoring and guiding therapeutic suppression of parathyroid hormone in renal patients having secondary hyperparathyroidism
Abstract:	The present invention relates to novel methods for monitoring and guiding therapeutic suppression of parathyroid hormone in renal patients having secondary hyperparathyroidism. One determines and monitors the level of cyclase activating parathyroid hormone and cyclase inactive parathyroid hormone in the renal patient. The parathyroid hormone suppressing therapeutic is administered to the patient so as to minimize the level of cyclase inactive parathyroid hormone.
Inventor(s):	Cantor; Thomas L. (El Cajon, CA)
Assignee:
Application Number:	10/002,818
Patent Claims:	1. A method for monitoring and guiding therapeutic suppression of parathyroid hormone in renal patients having secondary hyperparathyroidism comprising: a) determining and monitoring the level of cyclase activating parathyroid hormone in a renal patient having secondary hyperparathyroidism; b) determining and monitoring the level of cyclase inactive parathyroid hormone in the patient; and c) administering a therapeutic to the patient that suppresses cyclase activating parathyroid hormone whereby the amount of therapeutic administered is adjusted such that the level of cyclase inactive parathyroid hormone is minimized. 2. The method of claim 1 wherein the therapeutic is administered in increasing increments from a nominal amount. 3. The method of claim 1 wherein the patient is already receiving the therapeutic, also comprising terminating the therapeutic administration for a time sufficient to allow the patient to return to at least a relatively non-suppressed state. 4. The method of claim 1 wherein the patient is already receiving the therapeutic, also comprising adjusting the amount of therapeutic until the level of cyclase inactive hormone is minimized. 5. The method of claim 1 wherein the therapeutic administration is selected from the group comprising calcium administration, vitamin D analogue administration, and calcimimetic administration. 6. The method of claim 1 wherein steps a) and b) are performed using a sample obtained from a renal patient. 7. The method of claim 6 wherein the sample is selected from the group consisting of a serum, a plasma and a blood sample. 8. The method of claim 1, wherein the cyclase activating parathyroid hormone level is compared with the cyclase inactive parathyroid hormone level. 9. The method of claim 1, wherein the cyclase inactive parathyroid hormone level is determined by subtracting the cyclase activating parathyroid hormone level from the total parathyroid hormone level. 10. The method of claim 1, wherein the cyclase activating parathyroid hormone level is compared with the total parathyroid hormone level. 11. The method of claim 1, wherein the cyclase inactive parathyroid hormone level is compared with the total parathyroid hormone level. 12. The method of claim 1, wherein the cyclase activating parathyroid hormone level is compared with the cyclase inactive parathyroid hormone level in the form of a ratio or proportion. 13. The method of claim 1 wherein the hyperparathyroidism is caused by chronic renal failure. 14. The method of claim 1 wherein the cyclase activating parathyroid hormone level and the cyclase inactive parathyroid hormone level are determined using an immunoassay. 15. The method of claim 14 wherein the cyclase activating parathyroid hormone level is determined using an antibody that distinguishes cyclase activating parathyroid hormone from cyclase inactive parathyroid hormone. 16. The method of claim 14 wherein the cyclase inactive parathyroid hormone level is determined using an antibody that distinguishes cyclase activating parathyroid hormone from cyclase inactive parathyroid hormone. 17. The method of claim 1, wherein the therapeutic treatment for hyperparathyroidism is vitamin D or vitamin D analogue treatment, calcium treatment, or calcimimetic administration. 18. The method of claim 17 wherein the Vitamin D analogue is paricalcitrol or calcitriol. 19. The method of claim 1 further comprising monitoring for vascular calcification in said patients. 20. The method of claim 19 wherein vascular calcification is monitored by monitoring alkaline phosphatase levels. 21. The method of claim 3 wherein the time sufficient to allow the patient to return to at least a relatively non-suppressed state is between about two weeks to about six weeks. 22. The method of claim 3 wherein the time sufficient to allow the patient to return to at least a relatively non-suppressed state is about four weeks. 23. The method of claim 1, wherein the cyclase inactive parathyroid hormone is a peptide having an amino acid sequence from between PTH.sub.2-84 (SEQ ID NO:2) and PTH.sub.34-84 (SEQ ID NO:3) and functions in vivo as a parathyroid hormone antagonist or inhibitor. 24. The method of claim 1, wherein the cyclase inactive parathyroid hormone is a peptide having an amino acid sequence of human PTH.sub.7-84. 25. The method of claim 1, wherein the cyclase activating parathyroid hormone is a peptide having an amino acid sequence of human PTH.sub.1-84.

Details for Patent 6,524,788

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Nps Pharmaceuticals, Inc.	NATPARA	parathyroid hormone	For Injection	125511	01/23/2015		2039-02-26