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Claims for Patent: 5,861,386

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Claims for Patent: 5,861,386

Title: Method for treating and preventing secondary hyperparathyroidism
Abstract:A method for preventing loss of bone mass or bone mineral content in a human being suffering from secondary hyperparathyroidism by administering a sufficient amount of 1.alpha.--OH vitamin D.sub.2, 1.alpha.,24(S)--(OH).sub.2 vitamin D.sub.2, 1.alpha.--OH vitamin D.sub.4 or l.alpha.,24(R)--(OH).sub.2 vitamin D.sub.4.
Inventor(s): Knutson; Joyce C. (Madison, WI), Bishop; Charles W. (Verona, WI), Mazess; Richard B. (Madison, WI)
Assignee: Bone Care International, Inc. (Madison, WI)
Application Number:08/907,658
Patent Claims: 1. A method for lowering or maintaining lowered serum parathyroid hormone in human patients suffering from hyperparathyroidism, comprising: administering to said patients an effective amount of a vitamin D analog to lower and maintain lowered serum parathyroid hormone levels, said analog comprising formula (I): ##STR2## wherein A.sup.1 and A.sup.2 are either hydrogen or a carbon-carbon double bond between C--22 and C--23; and R.sup.1 is hydrogen or hydroxyl provided that when A.sup.1 and A.sup.2 are a double bond, R.sup.1 is hydrogen.

2. The method according to claim 1, wherein said analog of formula (I) is 1.alpha.--OH-vitamin D.sub.2 ; 1.alpha.--OH-vitamin D.sub.4 ; or 1.alpha.,24(R)--(OH).sub.2 -vitamin D.sub.4.

3. The method of claim 1 wherein said analog comprises a dosage of 1 to about 100 .mu.g/week.

4. The method of claim 1 wherein said analog, in solution, in a liquid vehicle ingestible by and nontoxic to said patients, is administered orally in encapsulated form.

5. The method of claim 1 wherein said analog is administered in combination with at least one agent characterized by said agent's ability to reduce loss of bone mass, or bone mineral content in patients.

6. The method of claim 5 wherein said agent includes other vitamin D compounds, conjugated estrogens, sodium fluorides, biphosphonates, cobalamin, pertussin toxin or boron.

7. The method of claim 1, wherein said administration of said analog is parenteral.

8. The method of claim 7 wherein said administration is by subcutaneous, intramuscular, or intravenous injection, nasopharyngeal or mucosal absorption, or transdermal absorption.

9. The method of claim 1 wherein said administration of said analog is nonparenteral.

10. A method for achieving an effect in a patient comprising administering to the patient an effective amount of a vitamin D analog of formula (I): ##STR3## wherein A.sup.1 and A.sup.2 are either hydrogen or a carbon-carbon double bond between C--22 and C--23: and R.sup.1 is hydrogen or hydroxyl provided that when A.sup.1 and A.sup.2 are a double bond, R.sup.1 is hydrogen, and wherein the effect is lowering or maintaining lowered serum parathyroid hormone levels, and thus decreasing loss of bone mass or bone mineral content.

11. The method of claim 2, wherein said analog is 1.alpha.--OH-vitamin D.sub.2.

12. The method of claim 1, wherein said analog is co-administered with a calcium phosphate binder.

13. A method of treating a human to alleviate or prevent the pathological effects of hyperparathyroidism, wherein the method comprises administering to the human in need thereof a vitamin D analog selected from the group consisting of 1.alpha.--OH-vitamin D.sub.2, 1.alpha.--OH-vitamin D.sub.4 and 1.alpha.,24(R)--(OH).sub.2 -vitamin D.sub.4 wherein said analog is administered to the human in an amount sufficient to lower or maintain lowered serum parathyroid hormone levels in the human to thereby alleviate or prevent the effects.

14. A method for lowering or maintaining lowered serum parathyroid hormone in human patients suffering from secondary hyperparathyroidism, comprising: administering to said patients an effective amount of a vitamin D analog to lower and maintain lowered serum parathyroid hormone levels, said analog comprising formula (I): ##STR4## wherein A.sup.1 and A.sup.2 are either hydrogen or a carbon-carbon double bond between C--22 and C--23; and R.sup.1 is hydrogen or hydroxyl provided that when A.sup.1 and A.sup.2 are a double bond, R.sup.1 is hydrogen.
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