Method for treating and preventing secondary hyperparathyroidism

• US 5,602,116 A
• Filed: 04/03/1995
• Issued: 02/11/1997
• Est. Priority Date: 08/02/1988
• Status: Expired due to Term

• Current Assignee: Genzyme Corporation (Sanofi )
• Original Assignee: Bone Care International LLC
• Inventors: Bishop, Charles W., Mazess, Richard B., Knutson, Joyce C.
• Primary Examiner(s): Criares, Theodore J.
• Application Number:
  US08/415,488
• Time in Patent Office: 680 Days
• Field of Search: 514/167, 552/653
• US Class Current: 514/167
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/565 not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
• CPC Class Codes: A61K 31/59 Compounds containing 9, 10- seco- cyclopenta[a]hydrophenanthrene ring systems
• CPC Class Codes: A61K 31/592 9,10-Secoergostane derivatives, e.g. ergocalciferol, i.e. vitamin D2
• CPC Class Codes: A61K 31/66 Phosphorus compounds
• CPC Class Codes: A61K 31/714 Cobalamins, e.g. cyanocobalamin, i.e. vitamin B12
• CPC Class Codes: A61K 33/00 Medicinal preparations containing inorganic active ingredients
• CPC Class Codes: A61K 33/06 Aluminium, calcium or magnesium; Compounds thereof , e.g. clay
• CPC Class Codes: A61K 33/16 Fluorine compounds
• CPC Class Codes: A61K 33/22 Boron compounds
• CPC Class Codes: A61K 38/23 Calcitonins
• CPC Class Codes: A61P 13/02 of urine or of the urinary tract, e.g. urine acidifiers
• CPC Class Codes: A61P 15/00 Drugs for genital or sexual disorders for disorders of sex hormones A61P5/24; Contraceptives
• CPC Class Codes: A61P 19/10 for osteoporosis
• CPC Class Codes: A61P 3/02 Nutrients, e.g. vitamins, minerals
• CPC Class Codes: A61P 3/14 for calcium homeostasis vitamin D A61P3/02; parathyroid hormones A61P5/18; calcitonin A61P5/22; osteoporosis A61P19/10; bone metastasis A61P35/04
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: A61P 5/20 for decreasing, blocking or antagonising the activity of PTH

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 1α-OH vitamin D₂, 1α,24(S)-(OH)₂ vitamin D₂, 1α-OH vitamin D₄ or 1α,24(R)-(OH)₂ vitamin D₄.

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 C₂₂ and C₂₃ ; and

R₁ is hydrogen or hydroxyl provided that when B and C are a double bond, R₁ is hydrogen.

2. The method according to claim 1, wherein said analog of formula (I) is 1α

-OH-vitamin D₂ ;

1α

-OH-vitamin D₄ ;

or 1α

,24(R)-(OH)₂ -vitamin D₄.

3. The method of claim 2 wherein said analog comprises a dosage of 1 to about 100 μ

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 1α

-OH-vitamin D2.

8. The method of claim 2, wherein said analog is 1α

, 24-(OH)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 1α

-OH-vitamin D₂ ;

1α

-OH-vitamin D₄ ; and

1α

,24(R)-(OH)₂ -vitamin D₄ 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.