Abstract: A novel therapy concept based on a removal of circulating BSP (bone sialoprotein) from the plasma of patients with chronic kidney disease (CKD) or highly at risk of developing arterial and vascular calcifications. The method comprises method of treatment of extracellular tissue and vascular calcifications, atherosclerosis, arteriosclerosis, and arterial calcification. The beneficial effects of this therapy have been proven by the observed correspondence between levels of circulating free BSP levels and mortality of CKD patients as well as in animal models.

Abstract: A method is disclosed for obtaining an antibody or antibody fragment to a conformational epitope specific for misfolded inactive human parathyroid hormone and fragments thereof. The method includes the steps of a) immunizing an animal with an immunogen which comprises oxidized parathyroid hormone or an oxidized fragment of parathyroid hormone, or both; and b) recovering an antibody, antibody fragments, or single chain antibody. The complementary determining region of the recovered antibody, antibody fragment or single chain antibody is capable of specifically recognizing a conformational epitope (antigenic determinant) which is present on oxidized parathyroid hormone and fragments thereof only but not regular bioactive human parathyroid hormone.

Abstract: The present invention provides a novel therapy concept based on a removal of circulation BSP (bone sialoprotein) from the plasma of patients with chronic kidney disease (CKD), preferably by plasmapheresis or an administration of antibodies against BSP in plasma. The present invention further provides a BSP absorber material for plasmapheresis and a pharmaceutical composition namely in form of anti-BSP antibodies for direct administration which are biocompatible in humans. The beneficial effects of this therapy have been proven by the observed correspondence between levels of circulating free BSP levels and mortality of CKD patients.

Abstract: Method of diagnosis and prognosis of contrast media induced nephropathy (CIN) including the steps of i) taking a urine sample from a patient exposed to the application of contrast media, notably patients subjected to coronary angiography; ii) assessing the level of vitamin D binding protein (VDBP) in the urine sample obtained in step (i); iii) relating the urinary vitamin D binding protein level determined in step (ii) to a pre-selected threshold level. A urinary vitamin D binding protein level higher than the pre-selected threshold level indicates that the patient is at risk of renal failure and in need of a dialysis treatment.

Abstract: The present invention provides a novel therapy concept based on a removal of circulation BSP (bone sialoprotein) from the plasma of patients with chronic kidney disease (CKD), preferably by plasmapheresis or an administration of antibodies against BSP in plasma. The present invention further provides a BSP absorber material for plasmapheresis and a pharmaceutical composition namely in form of anti-BSP antibodies for direct administration which are biocompatible in humans. The beneficial effects of this therapy have been proven by the observed correspondence between levels of circulating free BSP levels and mortality of CKD patients.

Abstract: Method of diagnosis and prognosis of contrast media induced nephropathy (CIN) comprising the steps of i) taking a urine sample from a patient exposed to the application of contrast media, notably patients subjected to coronary angiography; ii) assessing the level of vitamin D binding protein (VDBP) in the urine sample obtained in step (i); iii) relating the urinary vitamin D binding protein level determined in step (ii) to a pre-selected threshold level, wherein a urinary vitamin D binding level higher than said pre-selected threshold level indicates that the patient is at risk of renal failure and in need of a dialysis treatment.

Abstract: A new method of in vitro monitoring and assessing the need of a medication which interferes with the regulation of the parathyroid hormone level in a kidney patient subject to oxidative stress, notably hemodialysis patients. FIG. 1 shows the distribution of n-oxPTH concentrations in 340 hemodialysis patients (224 men and 116 women) with a median age of 66 years (IQR, 56 to 75 years), a median time since initiation of dialysis (dialysis vintage) of 266 days (IQR, 31 to 1209 days), and a median dialysis dose (kt/V) of 1.2 (IQR, 1.1 to 1.3). The cause of chronic kidney disease was nephrosclerosis in 113 cases (33%), diabetic nephropathy in 107 cases (31%), chronic glomerular nephritis in 29 cases (9%), polycystic kidney disease in 9 cases (3%) and other/unknown in 82 cases (24%). The median n-oxPTH concentration was 5.9 ng/L (IQR, 2.4 to 14.0 ng/L). n-oxPTH concentrations were not different in men and women (5.9 ng/L; IQR, 2.4 to 14.2 ng/L; n=224; vs. 5.5 ng/L; IQR, 2.4 to 14.0 ng/L; n=1 16; p=0.915).

Abstract: Method for obtaining an antibody or antibody fragment to a conformational epitope specific for oxidized, inactive human parathyroid hormone and fragments thereof; a method for removal of oxidized, inactive human parathyroid hormone from a sample of body fluid; methods of determining the concentration of active parathyroid hormone in a sample, and an in vitro method of diagnosis of renal failure or secondary hyperthyroidism in patients on dialysis.

Abstract: A bone graft or biocomposite for treating osseous defects and neogenesis of bone which is a composite of a biodegradable polymer and granules of beta-tricalciumphosphate, further comprising as active ingredient and embedded in the biodegradable polymer a physiologically effective amount of underglycosylated recombinant human BSP as a multi-dental clathrate with a basic organic compound which simulataneously is active as a plasticizer for the biodegradable polymer. The biocomposite is moldable and shapeable, hardens rapidly in situ when placed by surgery or prosthetic dentistry and which furthers osseous repair and the healing of damage or diseased tissues and lesions.

Abstract: The invention relates to a method of therapy against tumors and their metastases, which preferentially settle in bone tissue, comprising administering to a patient in need thereof an active ingredient which comprises at least one binding molecule that binds to human bone sialoprotein or a fragment thereof.

Abstract: Method and test kit for quantitative determination of Vitamin D metabolites in blood, wherein a predetermined amount of blood is pre-analytically immobilised on a solid sorption material. Thereby, hemolysis of the blood has no effect on the analysis of vitamin D metabolites. For quantitative analysis the dried blood spot on the sorption material is dissolved with an aqueous solvent buffer containing detergent, pH 7.0 to 10.0, and the vitamin D metabolites are eluted with a protic organic solution having a permittivity of less than 35. The eluate is analysed for vitamin D metabolites using conventional methods.

Abstract: Method for the quantitative determination of vitamins, amino acids, or other substances necessary for life, in a substance mixture, whereby in the culture container, the cavities of a microtitration plate, in each case a predetermined number of vital cells of a suitable microorganism are prepared in a permanent manner. For this purpose, the cells are shock frozen at ?80° C. and then freeze dried in a freezing solution containing 200 to 500 mM trehalose/sucrose. The freezing solution is preferably the test medium. The culture containers are preferably the wells of a microtitration plate.

Abstract: The invention is relates to drugs on the basis of antibodies against non-cellular bone matrix proteins, especially BSP, for use in the prevention and treatment of bone metastases. According to the invention, the antibodies are induced in the patient by recombinantly expressing antigenic determinants of bone matrix proteins in Listeria and anchoring them on the surfaces thereof. The antigenic determinants are selected according to whether they are characteristic of antigens that are expressed by the tumor cells themselves.

Abstract: A bone graft or biocomposite for treating osseous defects and neogenesis of bone which is a composite of a biodegradable polymer and granules of beta-tricalciumphosphate, further comprising as active ingredient and embedded in the biodegradable polymer a physiologically effective amount of underglycosylated recombinant human BSP as a muti-dental clathrate with a basic organic compound which simulataneously is active as a plasticizer for the biodegradable polymer. The biocomposite is moldable and shapeable, hardens rapidly in situ when placed by surgery or prosthetic dentistry and which furthers osseous repair and the healing of damage or diseased tissues and lesions.

Abstract: The preparation of vitamin D compounds of formula (I) with a label attached to a spacer group in the 3 position is disclosed. In the above formula (I), O represents the oxygen atom of an ether group; Y represents hydrogen or hydroxy; A represents a label such as biotin, digoxigenin, or another vitamin D group; R represents a substituted hydrocarbon side-group of vitamin D or a vitamin D metabolite. Also disclosed is a method of measuring 25-hydroxy vitamin D metabolite and a 1?,25-dihydroxy vitamin D metabolite in a sample.

Abstract: Composition for treatment and prevention of human hair loss and/or hair greying, comprising an effective amount of thymic peptides of the family thymulin, thymosin alpha-1 and thymosin beta-4 and pharmaceutical excipient, diluent or carrier. Method and pharmaceutical composition for treatment and prevention of balding, hair loss, and alopecia.

Abstract: A method for quantitating vitamin D metabolites directly in blood plasma or serum, without the need for prior purification of the vitamin D metabolites, comprising a digestion of the serum proteins with a serine protease such as proteinase K and sequence of steps for inhibiting the proteinase K activity in the competitive binding analysis. The advantages of this method are its high accuracy over the whole range of physiologically relevant values and that it can be easily adapted for a fully automated analysis of serum and plasma samples.

Abstract: Implant articles with improved osseointegrating properties, osteogenic implant materials, and process of inducing differentiation of mesenchymal stem cells, proliferation of osteoblast and attachment of cells to implant surface, comprising the step of impregnating the surface with a solution containing osteoactive bone sialoprotein, recombinant human bone sialoprotein, recombinant His-Myc-Ek-BSP or substantive fragments thereof that have not been in contact with serum containing complement factor H or any other BSP processing material.

Abstract: The invention relates to a medicament against tumors and their metastases, which preferentially settle in bone tissue, comprising active ingredient at least one binding molecule that binds to bone sialoprotein or a fragment thereof in serum or plasma.

Abstract: Diagnosis system or immunoassay for the determination of the effective parathyroid hormone activity in a sample, and for a diagnosis and treatment of calcium metabolism disturbances, osteopathies and hyper- or hypoparathyroidisms. The parathyroid hormone activity is measured with the aid of an antibody which binds to an epitope in the region of the receptor binding structure 15 to 22 of the parathyroid hormone, and an antibody which recognises whether the amino-terminal end 1 to 3 of the parathyroid hormone is intact. The assay permits the antagonistic characteristics of some parathyroid hormone fragments to be taken into account.