Method for treating secondary hyperparathyroidism in CKD
A stable, controlled release formulation for oral dosing of vitamin D compounds is disclosed. The formulation is prepared by incorporating one or more vitamin D compounds into a solid or semi-solid mixture of waxy materials. Oral dosage forms can be prepared by melt-blending the components described herein and filling gelatin capsules with the formulation.
1. A method of treating secondary hyperparathyroidism in a human patient having Chronic Kidney Disease (CKD), comprising administering to the patient an effective amount of a controlled release, oral dosage form of 25-hydroxyvitamin D to reduce the patient's serum parathyroid hormone level.
2. The method of claim 1 , wherein the patient has CKD Stage 5.
3. The method of claim 1 , wherein the patient has CKD Stage 1 or 2.
4. The method of claim 1 , wherein the patient has CKD Stage 3 or 4.
5. The method of claim 1 , wherein the patient's plasma intact parathyroid hormone level is reduced to the target range for the CKD Stage.
6. The method of claim 1 , wherein the patient's plasma intact parathyroid hormone level is reduced by at least 30% compared to the pre-treatment level.
7. The method of claim 1 , wherein the patient is vitamin D insufficient or vitamin D deficient.
8. The method of claim 7 , wherein said effective amount of the controlled release, oral dosage form of 25-hydroxyvitamin D is also effective to increase the patient's serum total 25-hydroxyvitamin D level to at least about 30 ng/mL.
9. The method of claim 1 , wherein the patient is vitamin D replete.
10. The method of claim 1 , wherein said effective amount of the controlled release, oral dosage form of 25-hydroxyvitamin D is also effective to maintain the patient's serum total 25-hydroxyvitamin D at a level of about 30 ng/mL or above.
11. The method of claim 1 , wherein said effective amount of the controlled release, oral dosage form of 25-hydroxyvitamin D is also effective to raise and maintain the patient's serum 25-dihydroxyvitamin D at a level between about 50 ng/mL and about 90 ng/mL.
12. The method of claim 1 , wherein said effective amount of the controlled release, oral dosage form of 25-hydroxyvitamin D is also effective to raise and maintain the patient's blood 1,25-dihydroxyvitamin D at a level of at least about 30 pg/mL.
13. The method of claim 1 , wherein the 25-hydroxyvitamin D is selected from the group consisting of 25-hydroxyvitamin D 2 , 25-hydroxyvitamin D 3 , and a combination of 25-hydroxyvitamin D 2 and 25-hydroxyvitamin D 3 .
14. The method of claim 13 , wherein the 25-hydroxyvitamin D is 25-hydroxyvitamin D 3 .
15. The method of claim 1 , comprising administering said oral dosage on a schedule of once per day.
16. The method of claim 15 , comprising administering said oral dosage daily for at least one month.
17. The method of claim 15 , wherein the daily dose of 25-hydroxyvitamin D is in a range of 1 μg to 1000 μg.
18. The method of claim 15 , wherein the daily dose of 25-hydroxyvitamin D is in a range of 1 μg to 100 μg.
19. The method of claim 1 , wherein said effective amount of the controlled release, oral dosage form of 25-hydroxyvitamin D does not cause hypercalciuria.
20. The method of claim 1 , wherein said controlled release, oral dosage form of 25-hydroxyvitamin D comprises 25-hydroxyvitamin D 3 in a range of 1 μg to 100 μg, a waxy controlled release carrier agent, a lipoidic agent, and an oily vehicle for the 25-hydroxyvitamin D 3 .
21. A method of treating secondary hyperparathyroidism in a human patient having Chronic Kidney Disease (CKD), comprising administering to the patient an effective amount of a controlled release, oral dosage form of 25-hydroxyvitamin D to reduce the patient's serum parathyroid hormone level without causing hypercalcemia or hyperphosphatemia.
22. A method of treating secondary hyperparathyroidism in a human patient having Chronic Kidney Disease (CKD), comprising administering to the patient an effective amount of a controlled release, oral dosage form of 25-hydroxyvitamin D to reduce the patient's serum parathyroid hormone level by at least 30% while safely raising serum total 25-hydroxyvitamin D.