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PATENT GRANT DATE September 8, 1998
PATENT TITLE Methods of treating animals to maintain or enhance bone mineral content and compositions for use therein

PATENT ABSTRACT A method of treating an animal to maintain or enhance the mineral content of the bones of the animal consists of administering to the animal a safe and effective amount of CLA. Compositions for use in the method are also disclosed
PATENT INVENTORS This data is not available for free
PATENT ASSIGNEE This data is not available for free
PATENT FILE DATE August 7, 1996
PATENT REFERENCES CITED Y.L. Ha; N.K. Grimm and M.W. Pariza, Carcinogenesis, vol. 8, No. 12, pp. 1881-1887 (1987).
Y.L. Ha; N.K. Grimm and M.W. Pariza, J. Agric. Food Chem., vol. 37, No. 1, pp. 75-81 (1987).
S.F. Chin, W. Liu, J.M. Storkson, Y.L. Ha and M.W. Pariza, Journal of Food Composition and Analysis, vol. 5, pp. 185-197 (1992).
INFORM, vol. 7, No. 2 (Feb. 1996), "Conjugated Linoleic Acid Offers Research Promise".
PATENT CLAIMS We claim:

1. A method of maintaining or enhancing the mineral content of bone in an animal, said method comprising administering orally or parenterally to said animal a safe amount of conjugated linoleic acid, said amount being effective to maintain or enhance said mineral content, the conjugated linoleic acid comprising an isomer having a pair of conjugated double bonds, the isomer being selected from a group consisting of cis-9, cis-11-octadecadienoic acid, cis-9, trans-11-octadecadienoic acid, trans-9, cis-11-octadecadienoic acid, trans-9, trans-11-octadecadienoic acid, cis-10, cis-12-octadecadienoic acid, cis-10, trans-12-octadecadienoic acid, trans-10, cis-12-octadecadienoic acid, and trans-10, trans-12-octadecadienoic acid.

2. The method of claim 1 in which the conjugated linoleic acid is a triglyceride of a conjugated linoleic acid.

3. The method of claim 1 in which the conjugated linoleic acid is a sodium salt of a conjugated linoleic acid.

4. The method of claim 1 in which the conjugated linoleic acid is a potassium salt of a conjugated linoleic acid.

5. The method of claim 1 in which the conjugated linoleic acid is a calcium salt of a conjugated linoleic acid.

6. The method of claim 1 in which the conjugated linoleic acid is 9,11-octadecadienoic acid.

7. The method of claim 1 in which the conjugated linoleic acid is 10,12-octadecadienoic acid.

8. A pharmaceutical composition for maintaining and enhancing bone calcium content comprising safe amounts of conjugated linoleic acid and a calcium source, the conjugated linoleic acid comprising a pair of conjugated double bonds, the isomer being selected from a group consisting of cis-9, cis-11-octadecadienoic acid, cis-9, trans-11-octadecadienoic acid, trans-9, cis-11-octadecadienoic acid, trans-9, trans-11-octadecadienoic acid, cis-10, cis-12-octadecadienoic acid, cis-10, trans-12-octadecadienoic acid, trans-10, cis-12-octadecadienoic acid, and trans-10, trans-12-octadecadienoic acid.

9. A pharmaceutical composition of claim 8 in which the calcium source is dibasic calcium phosphate.

10. A pharmaceutical composition of claim 8 in which the calcium source is calcium carbonate.

11. A method of maintaining or enhancing the calcium content of bone in an animal, said method comprising administering orally or parenterally to said animal safe amounts of a calcium source and conjugated linoleic acid, said amounts being effective to maintain or enhance the calcium content of bone in the animal, the conjugated linoleic acid comprising a pair of conjugated double bonds, the isomer being selected from a group consisting of cis-9, cis-11-octadecadienoic acid, cis-9, trans-11-octadecadienoic acid, trans-9, cis-11-octadecadienoic acid, trans-9, trans-11-octadecadienoic acid, cis-10, cis-12-octadecadienoic acid, cis-10, trans-12-octadecadienoic acid, trans-10, cis-12-octadecadienoic acid, and trans-10, trans-12-octadecadienoic acid.

12. The methods of claim 1 in which the conjugated linoleic acid is an active ester of a conjugated linoleic acid.
PATENT DESCRIPTION FIELD OF THE INVENTION

The present application generally relates to methods of treating animals, including humans. More particularly, it relates to methods of treating animals to maintain or enhance the mineral content of bone.

BACKGROUND OF THE INVENTION

It is known that many animals, including humans, lose bone minerals as they age or if they are afflicted with certain diseases. Researchers have observed that bone calcium loss or reduction in humans can cause osteoporosis. It also is known that maintaining or enhancing the bone calcium content can be beneficial in treating or preventing osteoporosis.

Most of the known chemical compounds that maintain or increase the bone calcium in the animal are potent biological agents which can have significant side effects.

It would be advantageous to have methods and compositions for maintaining or enhancing the mineral content of skeletal bones in animals without causing significant undesirable side effects.

BRIEF SUMMARY OF THE INVENTION

It is one object of the present invention to disclose a method of maintaining or enhancing the mineral content of skeletal bones in animals.

It is a still further object to disclose novel compositions for use in the methods of the invention.

We have discovered a method of maintaining or enhancing the mineral content of skeletal bones in an animal, including a human, which comprises administering to the animal a safe and effective amount of a conjugated linoleic acid, such as 9,11-octadecadienoic acid and 10,12-octadecadienoic acid, or active derivatives thereof, such as non-toxic salts, active esters, such as triglycerides, and mixtures thereof.

The conjugated linoleic acids, their non-toxic salts, active esters, active isomers, active metabolics, and mixtures thereof are referred to herein as "CLA."

The compositions of the present invention are pharmaceutical compositions which contain CLA in combination with a source of calcium, such as calcium carbonate, and optionally other ingredients.

It will be apparent to those skilled in the art that the forementioned objects and other advantages may be achieved by the practice of the present invention.

DESCRIPTION OF THE PREFERRED EMBODIMENT

In the preferred method of the present invention for maintaining or increasing the mineral content of skeletal bones of an animal, a safe and effective amount of CLA is administered to the animal.

Although CLA can be administered by itself to enhance or maintain bone mineral content, the preferred compositions of the present invention are pharmaceutical compositions which contain safe amounts of CLA and a calcium source, such as calcium carbonate, calcium phosphate or calcium carbonate. The compositions may also contain, without limitation, pharmaceutical diluents and other ingredients including vitamins, such as Vitamin D, and other minerals, such as zinc and magnesium salts. The pharmaceutical composition may be in the form of tablets, capsules or liquids for oral administration. Since CLA is a natural food ingredient and it is relatively non-toxic, the amount of CLA which can be administered is not critical as long as it is enough to be effective.

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PATENT PHOTOCOPY Available on request

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