Use of 2-methylene-19-nor-(20S)-1α,25-dihydroxyvitamin D3 to treat secondary hyperparathyroidism

Patent metadata

Field	Value
Publication number	US-9205096-B2
Application number	US-201313828090-A
Country	US
Kind code	B2
Filing date	Mar 14, 2013
Priority date	Jun 29, 2012
Publication date	Dec 8, 2015
Grant date	Dec 8, 2015

Abstract

Disclosed are methods of administering 2-methylene-19-nor-(20S)-1α,25-dihydroxyvitamin D 3 to treat and/or prevent secondary hyperparathyroidism and/or its accompanying symptoms in a subject having or at risk for developing secondary hyperparathyroidism.

First claim

We claim:

1. A method for treating secondary hyperparathyroidism or the symptoms thereof in a subject having secondary hyperparathyroidism, the method comprising administering a therapeutically effective amount of 2-methylene-19-nor-(20S)-1α,25-dihydroxyvitamin D 3 or pharmaceutically acceptable salts thereof to the subject at a dose level that treats secondary hyperparathyroidism or the symptoms thereof in the subject without inducing hypercalcemia in the subject.

2. The method of claim 1 , wherein the 2-methylene-19-nor-(20S)-1α,25-dihydroxyvitamin D 3 is formulated in an oral, topical, transdermal, parenteral, injection or infusion dosage form.

3. The method of claim 1 , wherein the subject is administered a therapeutically effective amount of 2-methylene-19-nor-(20S)-1α,25-dihydroxyvitamin D 3 three times per week.

4. The method of claim 1 , wherein the subject is receiving hemodialysis treatment.

5. The method of claim 1 , wherein the symptoms of secondary hyperparathyroidism are selected from the group consisting of elevated serum PTH, elevated serum phosphorus and elevated serum creatinine.

6. The method of claim 1 , wherein the subject is administered a therapeutically effective amount of 2-methylene-19-nor-(20S)-1α,25-dihydroxyvitamin D 3 or pharmaceutically acceptable salts thereof daily.

7. A method for treating secondary hyperparathyroidism or the symptoms thereof in a subject having secondary hyperparathyroidism, the method comprising administering a therapeutically effective amount of 2-methylene-19-nor-(20S)-1α,25-dihydroxyvitamin D 3 or pharmaceutically acceptable salts thereof to the subject at a dose level that reduces serum PTH levels in the subject without inducing hypercalcemia in the subject.

8. The method of claim 7 , wherein the 2-methylene-19-nor-(20S)-1α,25-dihydroxyvitamin D 3 is formulated in an oral, topical, transdermal, parenteral, injection or infusion dosage form.

9. The method of claim 7 , wherein the subject is receiving hemodialysis treatment.

10. The method of claim 7 , wherein the subject is administered a therapeutically effective amount of 2-methylene-19-nor-(20S)-1α,25-dihydroxyvitamin D 3 three times per week.

11. The method of claim 7 , wherein the administered dose level further reduces serum phosphorus and elevated serum creatinine.

12. The method of claim 7 , wherein the subject is administered a therapeutically effective amount of 2-methylene-19-nor-(20S)-1α,25-dihydroxyvitamin D 3 or pharmaceutically acceptable salts thereof daily.

13. A method for treating secondary hyperparathyroidism or the symptoms thereof in a subject having secondary hyperparathyroidism and established kidney failure with a glomerular filtration rate of less than 15 mL/min/1.73 m 2 , the method comprising administering a therapeutically effective amount of 2-methylene-19-nor-(20S)-1α,25-dihydroxyvitamin D 3 or pharmaceutically acceptable salts thereof to the subject at a dose level that treats secondary hyperparathyroidism or the symptoms thereof in the subject without inducing hypercalcemia in the subject.

14. The method of claim 13 , wherein the 2-methylene-19-nor-(20S)-1α,25-dihydroxyvitamin D 3 is formulated in an oral, topical, transdermal, parenteral, injection or infusion dosage form.

15. The method of claim 13 , wherein the subject is receiving hemodialysis treatment.

16. The method of claim 13 , wherein the subject is administered a therapeutically effective amount of 2-methylene-19-nor-(20S)-1α,25-dihydroxyvitamin D 3 three times per week.

17. The method of claim 13 , wherein the symptoms of secondary hyperparathyroidism are selected from the group consisting of elevated serum PTH, elevated serum phosphorus and elevated serum creatinine.

18. The method of claim 13 , wherein the subject is administered a therapeutically effective amount of 2-methylene-19-nor-(20S)-1α,25-dihydroxyvitamin D 3 or pharmaceutically acceptable salts thereof daily.

Assignees

• Wisconsin Alumni Res Found

Inventors

• Deluca Hector F
• Plum Lori A
• Zella Julia B
• Clagett-Dame Margaret

Classifications

• A61K31/593 Primary

  9,10-Secocholestane derivatives, e.g. cholecalciferol, i.e. vitamin D3 · CPC title

• A61P3/14

  for calcium homeostasis (vitamin D A61P3/02; parathyroid hormones A61P5/18; calcitonin A61P5/22; osteoporosis A61P19/10; bone metastasis A61P35/04) · CPC title

• A61K31/59

  Compounds containing 9, 10- seco- cyclopenta[a]hydrophenanthrene ring systems · CPC title

• A61P5/18

  of the parathyroid hormones · CPC title

• A61K9/48

  Preparations in capsules, e.g. of gelatin, of chocolate {(A61K9/0004 takes precedence; bite capsules A61K9/0056)} · CPC title