Key features and benefits
- Accurate and reliable results – providing a useful tool to identify non-adherent and non-responders to therapy.
- BAP levels are not affected by circadian variation – ease of sample collection, handling, and storage.
- BAP is cleared by the liver, not by the kidneys – levels are not affected by renal function.
- Clinically relevant measurement – as recommended in KDIGO guidelines.
- Complements the existing bone turnover panel aiding management of osteoporosis and other metabolic bone diseases.
- Ability to combine the bone turnover markers with the established IDS-iSYS 25-Hydroxy Vitamin DS – aiding management of osteoporosis and other metabolic bone diseases.
The IDS-iSYS Ostase® BAP assay is an in vitro diagnostic device intended for the quantitative determination of bone-specific alkaline phosphatase (BAP), an indicator of osteoblastic activity, in human serum or plasma on the IDS system.
Results are to be used in conjunction with other clinical and laboratory data to aid the clinician in the management of postmenopausal osteoporosis and Paget’s disease.
Ostase® is a registered trademark of Hybritech Incorporated, a subsidiary of Beckman Coulter, Inc.
Bone Alkaline Phosphatase (BAP) is a glycoprotein found on the surface of osteoblasts, which are the cells responsible for bone formation.
An accurate assessment of bone metabolism is critical for determining the severity of metabolic bone disease and responses to therapy.
Measurement of serum levels of BAP has been shown to be useful in evaluating patients with Paget’s disease, osteomalacia, primary hyperparathyroidism, renal osteodystrophy and osteoporosis1-5.
Paget’s disease of bone is a common skeletal disorder in which there is a focal proliferation of the normal cellular components of bone. Paget’s disease is more prevalent than once thought with the incidence rate in certain populations at 3 – 4% in middle-aged patients and 10 – 15% in the elderly6,8.
The excessive loss of bone mass with an increased susceptibility to fractures is a disorder known as osteoporosis5. The most common form of osteoporosis occurs in postmenopausal women and affects some 25 million postmenopausal women in the United States2,5.
Kidney Disease Improving Global Outcomes (KDIGO) Clinical Practice Guideline for the Diagnosis, Evaluation, Prevention and Treatment of CKD-MBD guidelines suggest that BAP is a marker to evaluate bone disease because markedly high or low values predict underlying bone turnover7.
- Epstein S. Serum and urinary markers of bone remodeling: assessment of bone turnover. Endocrine Reviews 9:437-448, 1988.
- Whyte MP. Alkaline phosphatase and the measurement of bone formation, Clinical Disorders of Bone and Mineral Metabolism. Potts JT and Frame B, eds., pp. 120-125, 1983.
- Garnero P and Delmas P. Assessment of the serum levels of bone alkaline phosphatase with a new immunoradiometric assay in patients with metabolic bone disease. J Clin Endocrin Metab 77:1046-1053, 1993.
- Cooper EH, Whelan P, and Purves D. Bone alkaline phosphatase and prostate-specific antigen in the monitoring of prostate cancer. The Prostate 25:236-242, 1994.
- Van Straalen JP, Sanders E, Prummel MF, and Sanders GTB. Bone alkaline phosphatase as indicator of bone formation. Clin Chim Acta 201:27-33, 1991.
- Merkow RL and Lane JM. Metabolic bone disease and Paget’s disease in the elderly: II. Paget’s Disease. Clin Rheum Dis 12:70, 1986.
- Schwarz P. et al. Paget’s disease of the bone after treatment with Denosumab: A case report. Bone 50 2012 1023–1025.