CA2360020A1 - Methods for differentiating and monitoring parathyroid and bone status related diseases - Google Patents

Methods for differentiating and monitoring parathyroid and bone status related diseases Download PDF

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Publication number
CA2360020A1
CA2360020A1 CA002360020A CA2360020A CA2360020A1 CA 2360020 A1 CA2360020 A1 CA 2360020A1 CA 002360020 A CA002360020 A CA 002360020A CA 2360020 A CA2360020 A CA 2360020A CA 2360020 A1 CA2360020 A1 CA 2360020A1
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Prior art keywords
parathyroid hormone
level
whole
peptide fragment
inhibitory peptide
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CA002360020A
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French (fr)
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CA2360020C (en
Inventor
Thomas L. Cantor
Ping Gao
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Scantibodies Laboratory Inc
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    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/26Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against hormones ; against hormone releasing or inhibiting factors
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/68Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
    • G01N33/6893Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids related to diseases not provided for elsewhere
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/74Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving hormones or other non-cytokine intercellular protein regulatory factors such as growth factors, including receptors to hormones and growth factors
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/74Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving hormones or other non-cytokine intercellular protein regulatory factors such as growth factors, including receptors to hormones and growth factors
    • G01N33/78Thyroid gland hormones, e.g. T3, T4, TBH, TBG or their receptors
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/30Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/34Identification of a linear epitope shorter than 20 amino acid residues or of a conformational epitope defined by amino acid residues
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2800/00Detection or diagnosis of diseases
    • G01N2800/04Endocrine or metabolic disorders
    • G01N2800/046Thyroid disorders
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2800/00Detection or diagnosis of diseases
    • G01N2800/10Musculoskeletal or connective tissue disorders
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10STECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S436/00Chemistry: analytical and immunological testing
    • Y10S436/811Test for named disease, body condition or organ function

Abstract

The present invention relates to novel methods and devices for differentiati ng in a patient parathyroid diseases, such as hyperparathyroidism and related bone diseases, from normal or non-disease states. One detects whole or non- fragmented (1 to 84) parathyroid hormone in a biological sample and also a large non-whole parathyroid hormone peptide fragment that can function as a parathyroid hormone antagonist. By either comparing values or using independently the value of either the large non-whole parathyroid hormone peptide fragment, the whole parathyroid hormone, or the combination of these values one is able to differentiate parathyroid and bone related disease states, as well as differentiate such states from normal states.

Claims (46)

1. A method for differentiating between a person having substantially normal parathyroid function and having hyperparathyroidism comprising determining and comparing at least two of the parameters selected from the group consisting of the whole parathyroid hormone level, the parathyroid hormone inhibitory peptide fragment level, and the total parathyroid hormone level in the person.
2. The method of Claim 1 wherein the comparison is in the form of a ratio or proportion.
3. The method of Claim 1 wherein the person is a patient with chronic uremia.
4. The method of Claim 1 wherein one measures the whole parathyroid hormone level and the total parathyroid hormone level in the person, determines the parathyroid hormone inhibitory peptide fragment level from these two measurements, and compares the whole parathyroid hormone level to the parathyroid hormone inhibitory peptide fragment level.
5. The method of Claim 4 wherein the comparison is in the form of a ratio or proportion.
6. The method of Claim 4 wherein the person is a patient with chronic uremia.
7. A method for differentiating between a person having substantially normal parathyroid function and having hyperparathyroidism comprising determining one parameter selected from the group consisting of the whole parathyroid hormone level, the parathyroid hormone inhibitory peptide fragment level, and a calculated total parathyroid hormone level.
8. The method of Claim 7 wherein one determines the parathyroid hormone inhibitory peptide fragment level by measuring the whole parathyroid hormone level and the total parathyroid hormone level.
9 The method of Claim 7 wherein one determines the total parathyroid hormone level by measuring the whole parathyroid hormone level and the parathyroid hormone inhibitory peptide fragment level.
10. The method of Claim 7 wherein the person is a patient with chronic uremia.
11. The method of Claim 1 wherein one measures and compares the whole parathyroid hormone level and the parathyroid hormone inhibitory peptide fragment level.
12. The method of Claim 11 wherein the comparison is in the form of a ratio or proportion.
13. The method of Claim 11 wherein the person is a patient with chronic uremia.
14. The method of Claim 1 wherein one measures and compares the whole parathyroid hormone level and the total parathyroid hormone level in the person.
15. The method of Claim 14 wherein the comparison is in the form of a ratio or proportion.
16. The method of Claim 14 wherein the person is a patient with chronic uremia.
17. The method of Claim 1 wherein one measures and compares the parathyroid hormone inhibitory peptide fragment level and the total parathyroid hormone level in the person.
18. The method of Claim 17 wherein the comparison is in the form of a ratio or proportion.
19. The method of Claim 17 wherein the person is a patient with chronic uremia.
20. A method for monitoring parathyroid related bone diseases and treatments therefor comprising determining and comparing at least two of the parameters selected from the group consisting of the whole parathyroid hormone level, the parathyroid hormone inhibitory peptide fragment level, and the total parathyroid hormone level in the person.
21. The method of Claim 20 wherein the comparison is in the form of a ratio or proportion.
22. The method of Claim 20 wherein one measures the whole parathyroid hormone level and the total parathyroid hormone level in the person, determines the parathyroid hormone inhibitory peptide fragment level from these two measurements, and compares the whole parathyroid hormone level to the parathyroid hormone inhibitory peptide fragment level.
23. The method of Claim 22 wherein the comparison is in the form of a ratio or proportion.
24. The method of Claim 20 wherein one measures and compares the whole parathyroid hormone level and the parathyroid hormone inhibitory peptide fragment level.
25. The method of Claim 20 wherein one measures and compares the whole parathyroid hormone level and the total parathyroid hormone level in the person.
26. The method of Claim 24 wherein the comparison is in the form of a ratio or proportion.
27. The method of Claim 25 wherein the comparison is in the form of a ratio or proportion.
28. The method of Claim 20 wherein one measures and compares the parathyroid hormone inhibitory peptide fragment level and the total parathyroid hormone level in the person.
29. The method of Claim 28 wherein one measures the whole parathyroid hormone level in order to calculate the parathyroid hormone inhibitory peptide fragment level from the whole parathyroid hormone level and the total parathyroid hormone level.
30. The method of Claim 28 wherein the comparison is in the form of a ratio or proportion.
31. A method for monitoring parathyroid related bone diseases and treatments therefor comprising determining one parameter selected from the group consisting of the whole parathyroid hormone level, the parathyroid hormone inhibitory peptide fragment level, and the calculated total parathyroid hormone level.
32. The method of Claim 31 wherein one determines the parathyroid hormone inhibitory peptide fragment level by measuring the whole parathyroid hormone level and the total parathyroid hormone level.
33. The method of Claim 31 wherein one determines the total parathyroid hormone level by measuring the whole parathyroid hormone level and the parathyroid hormone inhibitory peptide fragment level.
34. A method for monitoring the effects of therapeutic treatment for hyperparathyroidism comprising determining and comparing at least two of the parameters selected from the group consisting of the whole parathyroid hormone level, the parathyroid hormone inhibitory peptide fragment level, and the total parathyroid hormone level in the person.
35. The method of Claim 34 wherein the comparison is in the form of a ratio or proportion.
36. The method of Claim 34 wherein one measures the whole parathyroid hormone level and the total parathyroid hormone level in the person, determines the parathyroid hormone inhibitory peptide fragment level from these two measurements, and compares the whole parathyroid hormone level to the parathyroid hormone inhibitory peptide fragment level.
37. The method of Claim 36 wherein the comparison is in the form of a ratio or proportion.
38. The method of Claim 34 wherein one measures and compares the whole parathyroid hormone level and the parathyroid hormone inhibitory peptide fragment level.
39. The method of Claim 34 wherein one measures and compares the whole parathyroid hormone level and the total parathyroid hormone level in the person.
40. The method of Claim 39 wherein the comparison is in the form of a ratio or proportion.
41. The method of Claim 34 wherein one determines and compares the parathyroid hormone inhibitory peptide fragment level and the total parathyroid hormone level in the person.
42. The method of Claim 41 wherein one determines the parathyroid hormone inhibitory fragment level by measuring the whole parathyroid hormone and the total parathyroid hormone level.
43. The method of Claim 41 wherein the comparison is in the form of a ratio or proportion.
44. A method for monitoring the effects of therapeutic treatment for hyperparathyroidism comprising determining one parameter selected from the group consisting of the whole parathyroid hormone level, the parathyroid hormone inhibitory peptide fragment level, and the calculated total parathyroid hormone level.
45. The method of Claim 44 wherein one determines the parathyroid hormone inhibitory peptide fragment level by measuring the whole parathyroid hormone level and the total parathyroid hormone level.
46. The method of Claim 44 wherein one determines the total parathyroid hormone level by measuring the whole parathyroid hormone level and the parathyroid hormone inhibitory peptide fragment level.
CA2360020A 1999-01-14 2000-01-13 Methods for differentiating and monitoring parathyroid and bone status related diseases Expired - Fee Related CA2360020C (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US09/231,422 US6689566B1 (en) 1999-01-14 1999-01-14 Methods, kits, and antibodies for detecting parathyroid hormone
US09/344,639 1999-06-26
US09/344,639 US6743590B1 (en) 1999-01-14 1999-06-26 Methods for differentiating and monitoring parathyroid and bone status related diseases
US09/231,422 1999-06-26
PCT/US2000/000855 WO2000042437A1 (en) 1999-01-14 2000-01-13 Methods for differentiating and monitoring parathyroid and bone status related diseases

Publications (2)

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CA2360020A1 true CA2360020A1 (en) 2000-07-20
CA2360020C CA2360020C (en) 2012-03-20

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US (6) US6689566B1 (en)
EP (2) EP1151307B1 (en)
JP (1) JP4132677B2 (en)
AT (1) ATE354803T1 (en)
CA (1) CA2360020C (en)
DE (1) DE60033499T2 (en)
ES (1) ES2277827T3 (en)
WO (1) WO2000042437A1 (en)

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ATE354803T1 (en) 2007-03-15

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