Authors' objectives:

This review assesses the clinical effectiveness of Ostase for four clinical indications: Paget's disease of bone, renal osteodystrophy, prostate cancer and osteoporosis. Specific clinical questions were formulated from information on current clinical practice (ie, common usage of bone alkaline phosphatase (BALP). tests in Australia) and the purpose of the test (eg, the diagnosis of disease or evaluation of treatment).

Authors' results and conclusions: Safety Ostase is an in vitro diagnostic laboratory test that measures BALP in human sera. As such, there is no safety risk to patients. Laboratory staff and organisations intending to use the Ostase laboratory kit should ensure the safe handling of blood and other fluids as outlined in the health and safety guidelines of the National Pathology Accreditation Advisory Council. Diagnostic accuracy The conclusions regarding the diagnostic accuracy of BALP for Paget's disease of bone, renal osteodystrophy, prostate cancer and osteoporosis are based on a small number of studies. Many of the studies also show methodological biases, which further limit the extent to which inferences can be applied to the wider clinical population. On the basis of the evidence available, it would appear that Ostase has the potential to be useful as a supplementary test in the diagnosis of Paget's disease, differentiation of renal osteodystrophy, diagnosis of bone metastases of prostate cancer, and monitoring treatment in women with osteoporosis. However, supportive evidence of the diagnostic accuracy of Ostase is required from larger, more representative studies. Impact on clinical decision-making and health outcomes As no studies were retrieved that specifically assessed the role of Ostase in clinical decision-making or on patient outcomes for Paget's disease of bone, renal osteodystrophy, prostate cancer or osteoporosis, it was not possible to assess its impact in these areas. Therefore, the clinical value of the determination of BALP by Ostase was not adequately demonstrated in the studies reviewed to date.

Authors' recommendations: Since there is currently insufficient evidence pertaining to the effectiveness and cost-effectiveness of Ostase diagnostic laboratory tests (Tandem-R Ostase, Tandem-MP Ostase and Access Ostase) in the diagnosis and monitoring of treatment in Paget's disease of bone, renal osteodystrophy, bone metastases of prostate cancer and osteoporosis, MSAC recommended that public funding should not be supported at this time for these tests.

Authors' methods: Systematic review

Project Status: Completed

URL for project: http://www.msac.gov.au/

Year Published: 2003

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Australia

Organisation Name: Medical Services Advisory Committee

Contact Address: MSAC (MDP 107), GPO Box 9848, Canberra, ACT 2601, Australia. Tel: +61 2 6289 6811; Fax: +61 2 6289 8799.

Contact Name: msac.secretariat@health.gov.au

Contact Email: msac.secretariat@health.gov.au

Copyright: Medicare Services Advisory Committee (MSAC)