Claims for Patent: 7,541,140

Summary for Patent: 7,541,140

Title:	Assessing risk for kidney stones using parathyroid hormone agonist and antagonist
Abstract:	The present invention relates to identifying the risk of a subject developing renal stones utilizing an assessment of PTH agonist, antagonist and/or total PTH levels, optionally together with an assessment of serum and/or urine calcium levels and/or other analytes. The present description further relates to monitoring and guiding treatment for renal stones and kits useful therefore.
Inventor(s):	Cantor; Thomas L. (El Cajon, CA)
Assignee:	Scantibodies Laboratory, Inc. (Santee, CA)
Application Number:	11/144,437
Patent Claims:	1. A method for determining the risk of a subject for developing renal calcium calculi comprising: a) determining the level of parathyroid hormone (PTH) agonist and the level of PTH antagonist in a sample obtained from a subject; b) comparing the level of PTH agonist and PTH antagonist in the sample in a ratio; and c) determining the risk for developing renal calcium calculi in the subject based on the ratio; wherein the PTH agonist is a peptide having an amino acid sequence of human 1-84 PTH (SEQ ID NO:1); and the PTH antagonist is-7-84 PTH (SEQ ID NO:7). 2. The method of claim 1, wherein the sample is a urine, blood or serum sample. 3. The method of claim 1 further comprising comparing the ratio to a reference standard, or to a ratio determined with a normal reference sample to determine the risk for developing renal calcium calculi in the subject. 4. The method of claim 1 further comprising determining a serum calcium level, a urinary calcium level or combination thereof in the subject. 5. The method of claim 4, wherein the risk for developing renal calcium calculi in the subject is determined based on the ratio, the serum calcium level, the urinary calcium level or a combination thereof. 6. The method of claim 1, wherein steps (a-c) are repeated for the subject at pre-designated time intervals. 7. The method of claim 6, wherein the ratio of a later interval is compared with: (1) a ratio in the subject obtained at an earlier interval; or (2) an average of ratios calculated from ratios obtained at two or more earlier intervals. 8. The method of claim 6, wherein if the ratio of PTH agonist versus PTH antagonist of a later interval is more than the ratio of PTH agonist versus PTH antagonist at a earlier interval or if there is a trend of increasing ratios of PTH agonist versus PTH antagonist over the course of one or more intervals, the subject is considered to be at risk for developing or having renal stones. 9. The method of claim 6 wherein the ratio is compared with a ratio obtained at an earlier interval. 10. The method of claim 1, wherein the risk determination is utilized to monitor and/or guide treatment for renal calculi. 11. The method of claim 10, wherein the determination of a higher or increasing risk indicates that treatment for renal calculi should be commenced, continued or modified, and the determination of a lower or decreasing risk indicates that treatment for renal stones should end, decrease or be modified. 12. The method of claim 1, further comprising determining the total PTH level in the sample and comparing the level of PTH agonist, PTH antagonist and/or the total PTH level in a ratio, and determining the risk for developing renal calcium calculi in the subject based on the ratio. 13. The method of claim 1, wherein the subject is a mammal. 14. The method of claim 13, wherein the mammal is a human.

Details for Patent 7,541,140

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Nps Pharmaceuticals, Inc.	NATPARA	parathyroid hormone	For Injection	125511	01/23/2015		2024-06-03