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Claims for Patent: 5,602,116

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Claims for Patent: 5,602,116

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 1.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:08/415,488
Patent Claims: 1. A method for lowering or maintaining lowered serum parathyroid hormone in human patients suffering from hyperparathyroidism secondary to end stage renal disease, 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 B and C are either hydrogen or a carbon-carbon double bond between C.sub.22 and C.sub.23 ; and R.sub.1 is hydrogen or hydroxyl provided that when B and C are a double bond, R.sub.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 2 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 administration of said analog is parenteral.

6. The method of claim 5 wherein said administration is by subcutaneous, intramuscular, or intravenous injection, nasopharyngeal or mucosal absorption, or transdermal absorption.

7. The method of claim 2, wherein said analog is 1.alpha.-OH-vitamin D2.

8. The method of claim 2, wherein said analog is 1.alpha., 24-(OH).sub.2 -vitamin D2.

9. A method of treating a human to alleviate or prevent the pathological effects of hyperparathyroidism secondary to end stage renal disease, wherein the method comprises administering orally to said 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 compound is administered to said human in an amount sufficient to lower serum parathyroid hormone levels as measured by blood serum level of parathyroid hormone over time after ingestion in said human to thereby alleviate or prevent said effects.
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