Patent ID: 6967081

Claim:
A method for the assessment of bone fragility and fracture risk, or osteoporosis, in a person, comprising the steps of a) measuring the concentration of gamma-carboxylated osteocalcin (COC in the body fluid sample of the said person) in the presence of EDTA by means of at least one monoclonal or polyclonal antibody or fragment thereof, said antibody or fragment i) is specific for gamma-carboxylated osteocalcin, ii) recognizes either an epitope occurring in the region of the amino acids 17–24 of the gamma-carboxylated osteocalcin molecule or the tertiary structure associated with the gamma-carboxylated osteocalcin, and iii) has specificity for gamma-carboxylated osteocalcin that is dependent on the presence of bivalent metal ions, said specificity is decreased in the presence of said metal ions; and optionally measuring the concentration of intact osteocalcin (IOC) or total osteocalcin (TOC) in a body fluid sample of said person and determining the ratio of COC to IOC(COC/IOC ratio) or the ratio of COC to TOC(COC/TOC ratio), and b) comparing i) the concentration of gamma-carboxylated osteocalcin (COC) for said person to the mean concentration of gamma-carboxylated osteocalcin (mean COC) in similar body fluid samples of the population of the same age and sex, or ii) the COC/IOC ratio or COC/TOC ratio for said person to the mean COC/IOC ratio or mean COC/TOC ratio, determined from measurements in similar body fluid samples of the population of the same age and sex, whereby i) a COC for said person that is lower than the mean COC is an indication of osteoporosis, bone fragility or increased risk of bone fracture in said person, or ii) a COC/IOC ratio or a COC/TOC ratio for said person that is lower than the mean COC/IOC ratio or mean COC/TOC ratio is an indication of osteoporosis, bone fragility or increased risk of bone fracture in said person.