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 Din 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.

1 . A method of treating and preventing secondary hyperparathyroidism in a patient suffering from chronic kidney disease, comprising increasing or maintaining blood concentrations of both 25-hydroxyvitamin D and 1,25-dihydroxyvitamin D in the patient by administering 25-hydroxyvitamin D 3  and optionally 25-hydroxyvitamin D 2 , wherein 25-hydroxyvitamin D 3  is the predominant prohormone in circulation. 
     
     
         2 . The method of  claim 1 , comprising administering said 25-hydroxyvitamin D compounds such that blood concentrations of 25-hydroxyvitamin D are increased to and maintained at or above 30 ng/mL. 
     
     
         3 . The method according to  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 3 , comprising administering the 1,25-dihydroxyvitamin D 2  as such that blood concentrations of serum total 1,25-dihydroxyvitamin D 2  are increased to or maintained within a patient's normal historical physiological range for serum total 1,25-dihydroxyvitamin D without causing side effects, including hypercalcemia, hyperphosphatemia, hypercalciuria and oversuppression of iPTH. 
     
     
         5 . A method of concurrently lowering or maintaining plasma iPTH levels, increasing or maintaining serum calcium levels, maintaining serum phosphorous levels, increasing or maintaining serum 25-hydroxyvitamin D, or increasing or maintaining serum 1,25-dihydroxyvitamin D levels in a human patient diagnosed with early stage CKD, comprising administering to the patient, 25-hydroxyvitamin D 3  and optionally 25-hydroxyvitamin D 2  and, further optionally as necessary, 1,25-dihydroxyvitamin D 2 , such that the blood concentrations of 25-hydroxyvitamin D in the patient are increased to and maintained at or above 30 ng/mL, with 25-hydoxyvitamin D 3  being the predominant prohormone, and blood concentrations of 1,25-dihydroxyvitamin D are increased to or maintained within a patient's normal historical physiological range for 1,25-dihydroxyvitamin D. 
     
     
         6 . A method of reducing the risk of over suppression of plasma iPTH levels in a patient undergoing treatment for elevated levels of plasma iPTH, or maintenance/prevention therapy for secondary hyperparathyroidism, comprising administering 25-hydroxyvitamin D 3  and optionally 25-hydroxyvitamin D 2  and, further optionally, as necessary, 1,25-dihydroxyvitamin D 2 , so that the blood concentrations of 25-hydroxyvitamin D are increased to and maintained at or above 30 ng/mL, with 25-hydoxyvitamin D 3  being the predominant prohormone, and blood concentrations of 1,25-dihydroxyvitamin D are increased to or maintained within a patient's normal historical physiological range for 1,25-dihydroxyvitamin D, and elevated plasma iPTH levels are decreased or controlled while avoiding an abnormally low bone turnover rate. 
     
     
         7 . A method of treatment, comprising proactively administering 25-hydroxyvitamin D 3  and/or Vitamin D 3 , optionally concurrently with administration of 25-hydroxyvitamin D 2 , and/or Vitamin D 2 , to an early stage CKD patient having the potential to develop secondary hyperparathyroidism due to Vitamin D insufficiency or deficiency. 
     
     
         8 . A method according to  claim 4 , comprising administering said 25-hydroxyvitamin D 3  to increase blood concentration of 25-hydroxyvitamin D in the patient to a level of at least 30 ng/mL. 
     
     
         9 . The method according to  claim 8 , further comprising administering said 25-hydroxyvitamin D 3  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. 
     
     
         10 . The method according to  claim 9 , comprising administering said 25-hydroxyvitamin D 3  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. 
     
     
         11 . The method according to  claim 2 , further comprising administering said 25-hydroxyvitamin D 3  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. 
     
     
         12 . The method according to  claim 11 , comprising administering said 25-hydroxyvitamin D 3  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. 
     
     
         13 . The method according to  claim 5 , further comprising administering said 25-hydroxyvitamin D 3  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. 
     
     
         14 . The method according to  claim 13 , comprising administering said 25-hydroxyvitamin D 3  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. 
     
     
         15 . The method according to  claim 6 , further comprising administering said 25-hydroxyvitamin D 3  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. 
     
     
         16 . The method according to  claim 15 , comprising administering said 25-hydroxyvitamin D 3  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. 
     
     
         17 . A method according to  claim 7 , comprising administering said 25-hydroxyvitamin D 3  to increase blood concentration of 25-hydroxyvitamin D in the patient to a level of at least 30 ng/mL. 
     
     
         18 . The method according to  claim 17 , further comprising administering said 25-hydroxyvitamin D 3  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. 
     
     
         19 . The method according to  claim 18 , comprising administering said 25-hydroxyvitamin D 3  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. 
     
     
         20 . The method according to  claim 7 , comprising administering 25-hydroxyvitamin D 3  such that 25-hydroxyvitamin D 3  is the predominant prohormone in circulation.