Bone health in breast cancer survivors following adjuvant bisphosphonate therapy: AZURE quantitative bone scan sub-study
摘要：
The phase III trial AZURE is evaluating adjuvant zoledronic acid (ZA) in 3360 stage II/III breast cancer patients. Patients receive standard adjuvant treatment for breast cancer +/ ZA 4 mg over 5 years (maximum 19 doses). The efficacy results from AZURE are anticipated in late 2010. Although the intensive schedule used in AZURE is anticipated to result in an increase in bone mineral density (BMD), the potential for long term suppression of bone remodelling and adverse effects on bone quality needs assessment. Following completion of treatment on AZURE, 240 patients (120 ZA and 120 control) will undergo bone health evaluation by DXA scan and bone turnover markers (N-telopeptide of type 1 collagen (NTX), serum type 1 procollagen N-terminal propeptide (P1NP), serum Trap 5b and urinary CTX) at baseline, 1, 2 and 5 years. 40 of these will also undergo quantitative bone scanning (QBS) to provide an indirect assesment of bone remodelling. QBS involves intravenous injection of 99mTc bound to methylene diphosphonate, followed by gamma camera whole body bone scans at multiple times up to 4 h and six consecutive blood samples within this time period. The technique yields a value for 99mTc skeletal plasma clearance (Kbone). Study endpoints are: i) a significant difference between the ZA treated and control groups on the baseline measurements of Kbone and ii) a significant change of Kbone from baseline at 2 years or 5 years, using patients as their own controls.
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DOI：
10.1016/j.bone.2010.10.078
被引量：
年份：
2011
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