Claims
- 1. A method of treating hyperparathyroidism associated with aging, comprising administering to a subject suffering therefrom an amount of active vitamin D formula sufficient to lower or maintain lowered blood parathyroid hormone (PTH) levels.
- 2. A method in accordance with claim 1, wherein the hyperparathyroidism is associated with Aging-Related Vitamin D Deficiency (ARVDD) syndrome.
- 3. A method in accordance with claim 2, wherein the ARVDD syndrome includes one or more conditions which is (1) primary vitamin D deficiency, (2) 1,25-dihydroxyvitamin D3 deficiency, and (3) 1,25-dihydroxyvitamin D3 resistance.
- 4. A method in accordance with claim 2, wherein the active vitamin D is a hydroxyvitamin D compound of formula (I):
- 5. A method in accordance with claim 3, wherein the compound of formula (I) is a hypocalcemic hydroxyvitamin D compound.
- 6. A method in accordance with claim 2, wherein the active vitamin D is a 1α-hydroxyvitamin D compound of formula (II):
- 7. A method in accordance with claim 2, wherein the active vitamin D is a 24-hydroxyvitamin D compound of formula (IV):
- 8. A method in accordance with claim 2 wherein the active vitamin D is 1α-hydroxyvitamin D4; 1α,25-dihydroxyvitamin D2; 1α-hydroxyvitamin D2, 1α,24-dihydroxyvitamin D2; 1α,24,25-trihydroxyvitamin D2; 1α,25-dihydroxyvitamin D3, 1α-dihydroxyvitamin D3; 1α,25-dihydroxyvitamin D4; 1α,24,25-trihydroxyvitamin D4; 24-hydroxyvitamin D2; or 24-hydroxyvitamin D4.
- 9. A method in accordance with claim 3 wherein the condition included with ARVDD syndrome is primary vitamin D deficiency.
- 10. A method in accordance with claim 3 wherein the condition included within ARVDD syndrome is 1,25-dihydroxyvitamin D3 deficiency.
- 11. A method in accordance with claim 3 wherein the condition included within ARVDD syndrome is 1,25-dihydroxyvitamin D3 resistance.
- 12. A method in accordance with claim 2 wherein the active vitamin D compound is co-administered with at least one agent characterized by said agent's ability to reduce loss of bone mass, or bone mineral content in patients.
- 13. A method in accordance with claim 12 wherein the agent is other vitamin D compounds, conjugated estrogens, sodium fluorides, bisphosphonates, cobalamin, pertussin toxin or boron.
- 14. A method in accordance with claim 12 wherein the vitamin D compound is administered before, after or concurrently with the other agent.
- 15. A method in accordance with claim 2 wherein the active vitamin D is administered in high dose on an intermittent or episodic dosing regime.
- 16. A method in accordance with claim 15 wherein the amount of active vitamin D is a high dose which is between about 10 μg to about 300 μg.
- 17. A method in accordance with claim 16 wherein the active vitamin D compound is 1α,25-dihydroxyvitamin D3 or 1α-dihydroxyvitamin D3.
- 18. A method in accordance with claim 15 wherein the high dose is administered once per week to once every 12 weeks.
- 19. A method in accordance with claim 2 wherein the amount of the vitamin D compound is administered parenterally or orally in combination with a pharmaceutically acceptable carrier.
- 20. A method in accordance with claim 19 wherein the amount of vitamin D compound is administered parenterally.
- 21. A method in accordance with claim 20 wherein the amount of vitamin D compound is administered intravenously.
- 22. A method in accordance with claim 19 wherein the active vitamin D compound is administered orally.
- 23. A method in accordance with claim 20 wherein the active vitamin D compound is administered in an episodic dose of about 1 μg to about 300 μg.
- 24. A method in accordance with claim 23 wherein the active vitamin D compound is administered in an episodic dose of about 20 μg to about 100 μg.
- 25. A method in accordance with claim 19 wherein the active vitamin D compound is co-administered with a phosphate binder.
- 26. The method of claim 20 wherein the active vitamin D compound is administered is by intravenous injection, nasopharyngeal or mucosal absorption, or transdermal absorption.
- 27. A method of treating one or more conditions included within aging-related vitamin D deficiency (ARVDD) syndrome in a subject suffering therefrom comprising, administering to the subject an amount of active vitamin D compound sufficient to lower elevated or maintain lowered serum parathyroid hormone levels.
- 28. A method in accordance with claim 27 wherein the active vitamin D compound is co-administered with at least one agent characterized by the agent's ability to reduce loss of bone mass or bone mineral content in patients experiencing or tending toward the loss of bone mass or bone mineral content.
- 29. A serum parathyroid hormone level lowering composition, in unit dosage form, comprising an effective amount of a compound of formula (III):
- 30. The composition claimed in claim 29 which further comprises, at least one co-administerable agent characterized by the agent's ability to reduce loss of bone mass or bone mineral content in mammals experiencing or tending toward the loss of bone mass or bone mineral content.
- 31. The composition as claimed in claim 30, wherein the agent is conjugated estrogens, calcitonin, sodium fluorides, bisphosphonates, calcium supplements, cobalamin, pertussin toxin or boron.
- 32. A co-administerable pharmaceutical combination which comprises the composition of claim 29, and a phosphate binder.
- 33. The combination of claim 32 wherein said phosphate binder is calcium carbonate or calcium acetate.
- 34. A method of ameliorating or preventing hyperparathyroidism associated with ARVDD in a subject suffering therefrom, comprising administering to the subject an amount of an active vitamin D compound sufficient to suppress elevated parathyroid activity.
- 35. A co-administrable pharmaceutical combination comprising (i) a hypocalcemic vitamin D compound and (ii) a bone agent which is conjugated estrogens, calcitonin, sodium fluorides, bisphosphonates, calcium supplements, cobalamin, pertussin toxin or boron.
- 36. A combination in accordance with claim 35 wherein the vitamin D compound is administered before, after or concurrently with the bone agent.
- 37. Method of treating 1,25-(OH)2 D3 resistance in a subject suffering therefrom comprising, administering to the subject an effective amount of an active vitamin D compound wherein the active vitamin D is administered in high dose on an intermittent dosing regime.
- 38. A combined pharmaceutical preparation comprising an active vitamin D compound and a bone agent, the preparation being adapted for the administration of the active vitamin D on an episodic basis, and the administration of the bone agent on a daily or episodic basis, to a subject having hyperparathyroidism and/or ARVDD.
- 39. A pharmaceutical packaging, comprising (i) a plurality of containers therein, at least one of the containers containing an active vitamin D compound, and at least one of the containers containing a bone agent, and (ii) instructions for co-administering the active vitamin D compound and the bone agent to a subject having hyperparathyroidism and/or ARVDD.
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation-in-part of U.S. patent application Ser. No. 09/501,093 filed Feb. 9, 2000 which is a continuation-in-part of U.S. patent application Ser. No. 09/086,969, filed May 29, 1998 which is a continuation-in-part of U.S. patent application Ser. No. 08/907,659 filed Aug. 8, 1997, now U.S. Pat. No. 5,869,473, and this application is a continuation-in-part of U.S. patent application Ser. No. 08/907,660 filed Aug. 8, 1997 which is a divisional of U.S. patent application Ser. No. 08/798,958, filed Feb. 11, 1997, now U.S. Pat. No. 5,707,980, which is a continuation of U.S. patent application Ser. No. 08/415,488, filed Apr. 3, 1995, now U.S. Pat. No. 5,602,116.
Divisions (1)
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Number |
Date |
Country |
Parent |
08798958 |
Feb 1997 |
US |
Child |
08907660 |
Aug 1997 |
US |
Continuations (1)
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Number |
Date |
Country |
Parent |
08415488 |
Apr 1995 |
US |
Child |
08798958 |
Feb 1997 |
US |
Continuation in Parts (4)
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Number |
Date |
Country |
Parent |
09501093 |
Feb 2000 |
US |
Child |
10127005 |
Apr 2002 |
US |
Parent |
09086969 |
May 1998 |
US |
Child |
09501093 |
Feb 2000 |
US |
Parent |
08907659 |
Aug 1997 |
US |
Child |
09086969 |
May 1998 |
US |
Parent |
08907660 |
Aug 1997 |
US |
Child |
10127005 |
Apr 2002 |
US |