# US 12,214,021 B2 · Study on lactoferrin regulation of bone formation by means of vitamin D receptor

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- Number: US 12,214,021 B2
- Document ID: US12214021B2
- Status: Granted
- Kind: B2
- Application number: 17/059,565
- Filed: 2018-05-31
- Published: 2021-07-29
- Granted: 2025-02-04
- Earliest claimed: 2018-05-31
- Assignees: China Agricultural University
- Applicants: China Agricultural University
- Inventors: Huiyuan Guo; Yixuan Li; Hao Zhang; Liang Zhao
- Web page: https://patentgrep.com/patent/US12214021B2

## CPC

- A61K 38/40: Transferrins, e.g. lactoferrins, ovotransferrins
- A23L 33/155: Vitamins A or D
- A23L 33/17: Amino acids, peptides or proteins
- A61K 31/59: Compounds containing 9, 10- seco- cyclopenta[a]hydrophenanthrene ring systems
- A61K 31/593: 9,10-Secocholestane derivatives, e.g. cholecalciferol, i.e. vitamin D3
- A61P 19/08: for bone diseases, e.g. rachitism, Paget's disease
- A61P 19/10: for osteoporosis
- C12Q 1/02: involving viable microorganisms
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A23L: FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF (preservation thereof A23B)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- C12Q: MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS (immunoassay G01N33/53); COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES

## Abstract

A use of lactoferrin in the preparation of a food or drug, the food or drug being used for activating a VDR signaling pathway, which is used for the treatment of bone disease, bone disease comprising: osteoporosis, bone damage, loss of bone calcium, incomplete bone development and bone abnormalities. The present invention further comprises screening for drugs that are used to promote osteoblast proliferation and differentiation by using an active state of the VDR signaling pathway.

## Claims

### Claim 1

A method of treating Vitamin D (VD)-deficient osteoporosis, comprising administering to a patient in need thereof lactoferrin at a dose of 100 mg/kg Body Weight (BW),
wherein Vitamin D Receptor (VDR) gene and protein levels increase in the patient.

### Claim 2 (depends on 1)

The method according to claim 1, wherein administration of the lactoferrin increases expression of the VDR gene by 25 to 35 times.

### Claim 3 (depends on 1)

The method according to claim 1, wherein administration of the lactoferrin promotes proliferation and differentiation of osteoblasts via increase in the VDR gene and the protein levels.

### Claim 4 (depends on 1)

The method according to claim 1, further administering vitamin D.

### Claim 5 (depends on 4)

The method according to claim 4, wherein the vitamin D is in a form of 25-OH D3 or 1.25(OH)2D3.

### Claim 6 (depends on 1)

The method according to claim 1, wherein the method maintains blood calcium balance by increasing reabsorption of calcium and phosphorus by the kidney, decreases calcium in urine, and promotes bone calcium deposition.

### Claim 7 (depends on 1)

The method according to claim 1, wherein administration of the lactoferrin increases bone mineral density of the VD-deficient bone osteoporosis.

### Claim 8 (depends on 1)

The method according to claim 1, wherein administration of the lactoferrin improves microstructure of trabecular bone of the VD-deficient bone osteoporosis.

### Claim 9 (depends on 1)

The method according to claim 1, wherein administration of the lactoferrin promotes expression of the VDR gene in the kidney, bone or colon.

### Claim 10 (depends on 1)

The method according to claim 1, wherein administration of the lactoferrin activates a VDR signaling pathway via endocytosis.

### Claim 11 (depends on 5)

The method of claim 5, wherein the concentration of 1.25(OH)2D3 is 0.1 to 10 nM.

### Claim 12

A method of treating Vitamin D (VD)-deficient osteoporosis, comprising administering to a patient in need thereof lactoferrin at a dose of 100 mg/kg Body Weight (BW) and 1.25(OH)2D3,
wherein the concentration of 1.25(OH)2D3 is 1 or 10 nM, and
wherein Vitamin D Receptor (VDR) gene and protein levels increase in the patient.