Method of safely and effectively treating and preventing secondary hyperparathyroidism in chronic kidney disease

Abstract

A method of treating and preventing secondary hyperparathyroidism in CKD by increasing or maintaining blood concentrations of both 25-hydroxyvitamin D and 1,25-dihydroxyvitamin D in a patient by administering 25-hydroxyvitamin D 3 with or without 25-hydroxyvitamin D 2 and, as necessary, 1,25-dihydroxyvitamin D 2 as a Vitamin D hormone replacement therapy.

What is claimed is: 
     
         1 . A method of treating secondary hyperparathyroidism in a patient suffering from chronic kidney disease Stage 3 or Stage 4, comprising administering to the patient an effective amount of 25-hydroxyvitamin D 3  and optionally 25-hydroxyvitamin D 2  to reduce the patient's serum parathyroid hormone level while safely raising or maintaining both serum total 25-hydroxyvitamin D and serum total 1,25-dihydroxyvitamin D, wherein serum 25-hydroxyvitamin D 3  is greater than serum 25-hydroxyvitamin D 2  or serum 25-hydroxyvitamin D 4 , and wherein said 25-hydroxyvitamin D 2 , when administered, is administered in a lesser amount than said 25-hydroxyvitamin D 3 . 
     
     
         2 . The method of  claim 1 , comprising administering said 25-hydroxyvitamin D 3  and optionally 25-hydroxyvitamin D 2  such that blood concentrations of 25-hydroxyvitamin D are increased to and maintained at or above 30 ng/mL. 
     
     
         3 . The method of  claim 1 , further comprising administering 1,25-dihydroxyvitamin D 2  as a Vitamin D hormone replacement therapy to the patient. 
     
     
         4 . The method of  claim 1 , comprising administering said 25-hydroxyvitamin D 3  and optionally 25-hydroxyvitamin D 2  such that blood concentrations of serum total 1,25-dihydroxyvitamin D are increased to or maintained within a patient's normal historical physiological range for serum total 1,25-dihydroxyvitamin D without causing side effects selected from the group consisting of hypercalcemia, hyperphosphatemia, hypercalciuria and oversuppression of iPTH. 
     
     
         5 . The method of  claim 2 , further comprising administering said 25-hydroxyvitamin D 3  and optionally 25-hydroxyvitamin D 2  to maintain blood concentration of 25-hydroxyvitamin D in the patient at a level of at least 30 ng/mL for at least 30 days. 
     
     
         6 . The method of  claim 5 , comprising administering said 25-hydroxyvitamin D 3  and optionally 25-hydroxyvitamin D 2  to maintain blood concentration of 25-hydroxyvitamin D in the patient at a level of at least 30 ng/mL for at least 90 days. 
     
     
         7 . The method of  claim 1 , wherein the patient's serum parathyroid hormone level is reduced by at least 30%. 
     
     
         8 . The method of  claim 1 , wherein the patient is vitamin D insufficient or vitamin D deficient. 
     
     
         9 . The method of  claim 1 , wherein the patient's serum parathyroid hormone level is reduced to the target range for the CKD Stage. 
     
     
         10 . The method of  claim 4 , wherein said amount of 25-hydroxyvitamin D 3  and optionally 25-hydroxyvitamin D 2  is further effective to maintain serum total 1,25-dihydroxyvitamin D within the patient's normal historical physiological range for at least 30 days. 
     
     
         11 . The method of  claim 1 , wherein said amount of 25-hydroxyvitamin D 3  and optionally 25-hydroxyvitamin D 2  is further effective to maintain the patient's serum parathyroid hormone level at a reduced level from baseline level for at least 30 days. 
     
     
         12 . The method of  claim 1 , wherein said amount of 25-hydroxyvitamin D 3  and optionally 25-hydroxyvitamin D 2  is further effective to concurrently maintain plasma PTH at a reduced level from baseline level, blood concentration of 25-hydroxyvitamin D at a level of at least 30 ng/mL, and blood concentration of 1,25-dihydroxyvitamin D within the patient's normal historical physiological range for at least 30 days. 
     
     
         13 . A method of treating secondary hyperparathyroidism in a patient suffering from chronic kidney disease Stage 3 or Stage 4, comprising administering to the patient an effective amount of 25-hydroxyvitamin D 3  and optionally 25-hydroxyvitamin D 2  to reduce the patient's serum parathyroid hormone level while safely raising or maintaining both serum total 25-hydroxyvitamin D and serum total 1,25-dihydroxyvitamin D, wherein serum total 25-hydroxyvitamin D is increased to and/or maintained in a range of 30 ng/mL to 90 ng/mL, wherein serum 25-hydroxyvitamin D 3  is greater than serum 25-hydroxyvitamin D 2  or serum 25-hydroxyvitamin D 4 , and wherein said 25-hydroxyvitamin D 2 , when administered, is administered in a lesser amount than said 25-hydroxyvitamin D 3 . 
     
     
         14 . The method according to  claim 13 , further comprising administering 1,25-dihydroxyvitamin D 2  as a Vitamin D hormone replacement therapy to the patient. 
     
     
         15 . The method of  claim 13 , comprising administering said 25-hydroxyvitamin D 3  and optionally 25-hydroxyvitamin D 2  such that blood concentrations of serum total  1 ,25-dihydroxyvitamin D are increased to or maintained within a patient's normal historical physiological range for serum total 1,25-dihydroxyvitamin D without causing side effects selected from the group consisting of hypercalcemia, hyperphosphatemia, hypercalciuria and oversuppression of iPTH. 
     
     
         16 . The method of  claim 13 , further comprising administering said 25-hydroxyvitamin D 3  and optionally 25-hydroxyvitamin D 2  to increase and/or maintain blood concentration of 25-hydroxyvitamin D in the patient in a range of 30 ng/mL to 90 ng/mL for at least 30 days. 
     
     
         17 . The method of  claim 13 , wherein the patient's serum parathyroid hormone level is reduced by at least 30%. 
     
     
         18 . The method of  claim 13 , wherein the patient is vitamin D insufficient or vitamin D deficient. 
     
     
         19 . The method of  claim 13 , wherein the patient's serum parathyroid hormone level is reduced to the target range for the CKD Stage. 
     
     
         20 . The method of  claim 13 , wherein said amount of 25-hydroxyvitamin D 3  and optionally 25-hydroxyvitamin D 2  is further effective to maintain the patient's serum parathyroid hormone level at a reduced level from baseline level for at least 30 days.