# US 5,700,693 A · Method to detect bone and other connective tissue disorders in humans and animals

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- Number: US 5,700,693 A
- Document ID: US5700693A
- Status: Granted
- Kind: A
- Application number: 08/471,364
- Filed: 1995-06-06
- Granted: 1997-12-23
- Earliest claimed: 1989-12-30
- Assignees: Rowett Research Institute
- Inventors: Simon Peter Robins
- Web page: https://patentgrep.com/patent/US5700693A

## CPC

- C07K 16/18: against material from animals or humans
- C07K 16/44: against material not provided for elsewhere {, e.g. haptens, metals, DNA, RNA, amino acids}
- G01N 33/6887: {from muscle, cartilage or connective tissue}
- G01N 2800/108: Osteoporosis
- Y10S 436/811: Test for named disease, body condition or organ function
- Y10S 436/813: Cancer
- Y10S 436/815: Test for named compound or class of compounds
- C07K: PEPTIDES (peptides in foodstuffs A23; obtaining protein compositions for foodstuffs, working-up proteins for foodstuffs A23J; preparations for medicinal purposes A61K; peptides containing beta-lactam rings C07D; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, C07D; ergot alkaloids of the cyclic peptide type C07D519/02; macromolecular compounds having statistically distributed amino acid units in their molecules, i.e. when the preparation does not provide for a specific; but for a random sequence of the amino acid units, homopolyamides and block copolyamides derived from amino acids C08G69/00; macromolecular products derived from proteins C08H1/00; preparation of glue or gelatine C09H; single cell proteins, enzymes C12N; genetic engineering processes for obtaining peptides C12N15/00; compositions for measuring or testing processes involving enzymes C12Q; investigation or analysis of biological material G01N33/00)
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)
- Y10S: TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS

## Abstract

The invention is directed to methods to assess connective tissue, especially bone, metabolism in disease or to monitor therapy, which method comprises assessing the levels of native free collagen-derived crosslinks in biological fluids, especially urine. The method can be enhanced by concomitantly determining the levels of an indicator of bone formation in biological fluids of the same individual and assessing the differences between the degradation marker and the formation indicator. Antibodies which are specifically immunoreactive with forms of crosslinks which occur free in biological fluids are also disclosed.

## Claims

### Claim 1

A method of screening for or monitoring a bone resorption disorder in a human subject, comprising,
obtaining a non-hydrolyzed urine sample from the subject,
determining a ratio of native peptide-free, non-glycosylated pyridinoline (N-Pyd)/creatinine, peptide-free deoxypyridinoline (N-Dpd)/creatinine, or both, in the sample, and
comparing the ratio determined with the same ratio for normal subjects, where an elevated ratio provides an indication that the test subject has an above-normal rate of bone resorption.

### Claim 2 (depends on 1)

The method of claim 1, wherein the ratio determined is N-Pyd/creatinine.

### Claim 3 (depends on 1)

The method of claim 1, wherein the ratio determined is N-Dpd/creatinine.

### Claim 4

A method of screening for or monitoring a bone resorption disorder related to osteoporosis, hyperparathyroidism, rheumatoid arthritis, osteoarthritis, a malignant tumor or metastatic cancer in bone, or Paget's disease in a human subject, comprising,
obtaining a non-hydrolyzed urine sample from the subject,
determining a ratio of native peptide-free, non-glycosylated pyridinoline (N-Pyd)/creatinine, peptide-free deoxypyridinoline (N-Dpd)/creatinine, or both, in the sample, and
comparing the ratio determined with the same ratio for normal subjects, where an elevated ratio provides an indication that the test subject may have one of the bone-resorption disorders.

### Claim 5 (depends on 4)

The method of claim 4, wherein the ratio determined is N-Pyd/creatinine.

### Claim 6 (depends on 4)

The method of claim 4, wherein the ratio determined is N-Dpd/creatinine.

### Claim 7 (depends on 4)

The method of claim 4, wherein the bone resorption disorder relates to osteoporosis.

### Claim 8 (depends on 4)

The method of claim 4, wherein the bone resorption disorder relates to hyperparathyroidism.

### Claim 9 (depends on 4)

The method of claim 4, wherein the bone resorption disorder relates to rheumatoid arthritis.

### Claim 10 (depends on 4)

The method of claim 4, wherein the bone resorption disorder relates to osteoarthritis.

### Claim 11 (depends on 4)

The method of claim 4, wherein the bone resorption disorder relates to a malignant tumor or metastatic cancer in bone.

### Claim 12 (depends on 4)

The method of claim 4, wherein the bone resorption disorder relates to Paget's disease.

### Claim 13 (depends on 4)

The method of claim 4, for screening for such a bone resorption disorder.