Claims for Patent: 9,329,190

Summary for Patent: 9,329,190

Title:	Assays and methods of treatment relating to vitamin D insufficiency
Abstract:	Described herein are assays directed to determining the level of bioavailable or free vitamin D in a blood sample in a subject. The values determined for bioavailable or free vitamin D indicate whether the subject suffers from insufficient levels of vitamin D. Also described herein are methods of treatment for vitamin D insufficiency.
Inventor(s):	Thadhani; Ravi (Boston, MA), Karumanchi; S. Ananth (Chestnut Hill, MA), Berg; Anders Hayden (Dedham, MA), Bhan; Ishir (West Newton, MA)
Assignee:	The General Hospital Corporation (Boston, MA) Beth Israel Deaconess Medical Center, Inc. (Boston, MA)
Application Number:	13/978,193
Patent Claims:	1. A method for determining a level of bioavailable vitamin D and a level of free vitamin D in a subject, the method comprising: performing assays on a blood sample obtained from the subject to determine a level of VDBP (vitamin D binding protein) polypeptide, albumin polypeptide and total vitamin D; calculating a level of bioavailable vitamin D, wherein a level of bioavailable vitamin D is: =(Kalb*[Alb]+1)*[Free Vitamin D] and calculating a level of free vitamin D, wherein a level of free vitamin D is: ={-{K.sub.DBP[Total DBP]-K.sub.DBP[Total Vitamin D]+K.sub.alb[Alb]+1}+ {(K.sub.DBP[Total DBP]-K.sub.DBP[Total Vitamin D]+K.sub.alb[Alb]+1).sup.2+4(K.sub.DBPK.sub.alb[Alb]+K.sub.DBP)([Total Vitamin D])}}/(2{K.sub.DBPK.sub.alb[Alb]+K.sub.DBP}). 2. The method of claim 1, wherein a level of bioavailable vitamin D lower than 25% of the mean value of bioavailable vitamin D in a population of healthy subjects indicates that the subject has a vitamin D insufficiency, and the method includes administering a vitamin D insufficiency treatment to a subject who is determined to have a vitamin D insufficiency. 3. The method of claim 1, wherein the vitamin D is selected from the group consisting of: 25-hydroxyvitamin D and 1,25-dihydroxyvitamin D. 4. The method of claim 1, wherein the assays to determine the level of VDBP polypeptide or albumin polypeptide comprises use of a method selected from the group consisting of: enzyme linked immunosorbent assay; chemiluminescent immunosorbent assay; electrochemiluminescent immunosorbent assay; fluorescent immunosorbent assay; dye linked immunosorbent assay; immunoturbidimetric assay; immunonephelometric assay; dye-based photometric assay; western blot; immunoprecipitation; radioimmunological assay (RIA); radioimmunometric assay; immunofluorescence assay and mass spectroscopy. 5. The method of claim 1, wherein the assays to determine the level of total vitamin D comprises the use of a method selected from the group consisting of: radioimmunoassay; liquid chromatography tandem mass spectroscopy; enzyme linked immunosorbent assay; chemiluminescent immunosorbent assay; electrochemiluminescent immunosorbent assay; fluorescent immunosorbent assay; and high-pressure liquid chromatography. 6. The method of claim 2, wherein an insufficiency of vitamin D indicates an increased risk of a condition selected from the group consisting of: decreased bone density; decreased bone mineral density; bone fractures; bone resorption; rickets; osteitis fibrosa cystica; fibrogenesis imperfect ossium; osteoschlerosis; osteoporosis; osteomalacia; elevated parathyroid hormone levels; parathyroid gland hyperplasia; secondary hyperparathyroidism; hypocalcemia; infection; cancer; psoriasis; cardiovascular disease; renal osteodystrophy; renal disease; end-stage renal disease; chronic kidney disease; chronic kidney disease-associated mineral and bone disorder; extraskeletal calcification; obesity; allergy, asthma; multiple sclerosis; muscle weakness; rheumatoid arthritis and diabetes. 7. The method of claim 2, wherein the treatment comprises administering a compound selected from the group consisting of: calcitriol; dihydrotachysterol; doxercalciferol; paricalcitol; cholecalciferol and ergocalciferol. 8. The method of claim 1, wherein level of bioavailable vitamin D and the level of free vitamin D are calculated by a processor.

Details for Patent 9,329,190

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Nps Pharmaceuticals, Inc.	NATPARA	parathyroid hormone	For Injection	125511	01/23/2015		2031-01-07