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Study Situation
In co-operation with the UKSH and the company CRC Kiel, clinical studies OSTEOGEO (100 post-menopausal women) and "Peak Bone" (30 healthy pre-menopausal women) were conducted. Additional women suffering from osteoporosis were found. This was to be expected due to the detection of calcium loss already at earlier stages and the observation of the whole skeleton. Values above the threshold indicate a balanced calcium balance and no osteoporosis. Values below the threshold indicate osteoporosis, a DXA measurement may be recommended to determine the current bone density.
Advantages compared to DXA bone density measurement:
The diagnosis can be made years earlier
Short-term (approx. 2-3 weeks) therapy monitoring is possible
The estimation of calcium loss per day is possible
No radiation exposure
How does the analysis procedure work?
Calcium (Ca++) occurs in food in isotopes of different weights, e.g. 42Ca or 44Ca. Isotopes react chemically in the same way, but have different weights. The calcium isotopes are stable and not radioactive.
Ca isotope values in blood and serum are plotted with their corresponding mean values for diet, faeces and calculated mean value for bone. There is no statistical difference in Ca isotope levels between the two groups in relation to diet (p = 0.3) or faeces (p = 0.6). However, women suffering from DXA-diagnosed osteoporosis showed significantly lower δ44/42Ca (serum) (p = 0.001) and δ44/42Ca(urine) (p = 0.004) values than women without osteoporosis.
The 42Ca/44Ca (δ44/42Ca) ratio can be used to conclude whether bone is built up or broken down. The measurement reflects the calcium build-up/loss, which can be converted into grams/day. We will add the algorithm here shortly.
Light Ca isotopes undergo chemical reactions faster than heavy ones and accumulate at the end of the process (in humans in the bone). Because light Ca isotopes react more quickly, light Ca isotopes (42Ca) are predominantly incorporated during bone formation.
If more light Ca isotopes are incorporated in the bone, more heavy Ca isotopes (44Ca) remain in the blood/urine. This can be measured with our new method. When bone substance is broken down (e.g. osteoporosis), the reverse happens. More light Ca isotopes are released from the bone into the blood/urine. This can also be measured. The graph shows the differences in the calcium isotope marker (CIM) in different materials in healthy people and people with osteoporosis.
Material
- 2ml serum and
- 10ml morning urine (acidified) and
- Completed medical history form with the patient's declaration of consent for the scientific use of the patient data for the purpose of further development.
