The ZOTECT study
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The ZOTECT study : Effect of zoledronic acid on bone metabolism in patients with bone metastases from prostate or breast cancer. / Hadji, Peyman; Ziller, May; Maurer, Tobias; Autenrieth, Michael; Muth, Mathias; Ruebel, Amelie; May, Christoph; Birkholz, Katrin; Diebel, Erhardt; Gleissner, Jochen; Rothe, Peter; Gschwend, Juergen E.
in: J BONE ONCOL, Jahrgang 1, Nr. 3, 12.2012, S. 88-94.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung
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TY - JOUR
T1 - The ZOTECT study
T2 - Effect of zoledronic acid on bone metabolism in patients with bone metastases from prostate or breast cancer
AU - Hadji, Peyman
AU - Ziller, May
AU - Maurer, Tobias
AU - Autenrieth, Michael
AU - Muth, Mathias
AU - Ruebel, Amelie
AU - May, Christoph
AU - Birkholz, Katrin
AU - Diebel, Erhardt
AU - Gleissner, Jochen
AU - Rothe, Peter
AU - Gschwend, Juergen E
PY - 2012/12
Y1 - 2012/12
N2 - PURPOSE: The ZOTECT study assesses the effect of zoledronic acid (ZOL) on bone-marker levels and potential correlations with disease outcomes in bisphosphonate-naive patients.METHODS: This prospective, single-arm, open-label study in bisphosphonate-naive (≥6 months) patients with bone metastases from prostate cancer (PC; n=301) or breast cancer (BC; n=99) enrolled at 98 German sites (May 2006 to July 2008) investigated the effect of ZOL (4 mg intravenously every 4 weeks×4 months, with a final follow-up at 12 months) on bone-marker levels. Secondary assessments: skeletal-related event (SRE) rate, pain, quality of life (QoL), and prostate-specific antigen levels. Endpoints were assessed using summary statistics by visit/tumor type and Kaplan-Meier analyses.RESULTS: ZOL treatment significantly decreased bone-marker levels (amino-terminal propeptide of type I collagen [P1NP], C-terminal cross-linking telopeptide of type I collagen [CTX]; P<0.0001), and this decrease was maintained through the final 1-year follow-up visit. Baseline P1NP and CTX levels correlated with extent of bone disease (P<0.0001, each) and on-treatment decreases in marker levels. Skeletal disease burden and bone-marker levels were similar between PC and BC patients, and ZOL did not significantly influence osteoprotegerin/receptor activator of nuclear factor-κB ligand levels. Only 13 SREs occurred in 11 patients, supporting the known ZOL-mediated reduction in SREs. On-treatment bone-marker level changes did not correlate with SRE rate, pain scores, or QoL. Generally, ZOL was well tolerated and adverse events were consistent with its known safety profile.CONCLUSIONS: This study confirms that ZOL therapy significantly reduces bone turnover (measured as P1NP and CTX levels) in patients with bone metastases from PC or BC.
AB - PURPOSE: The ZOTECT study assesses the effect of zoledronic acid (ZOL) on bone-marker levels and potential correlations with disease outcomes in bisphosphonate-naive patients.METHODS: This prospective, single-arm, open-label study in bisphosphonate-naive (≥6 months) patients with bone metastases from prostate cancer (PC; n=301) or breast cancer (BC; n=99) enrolled at 98 German sites (May 2006 to July 2008) investigated the effect of ZOL (4 mg intravenously every 4 weeks×4 months, with a final follow-up at 12 months) on bone-marker levels. Secondary assessments: skeletal-related event (SRE) rate, pain, quality of life (QoL), and prostate-specific antigen levels. Endpoints were assessed using summary statistics by visit/tumor type and Kaplan-Meier analyses.RESULTS: ZOL treatment significantly decreased bone-marker levels (amino-terminal propeptide of type I collagen [P1NP], C-terminal cross-linking telopeptide of type I collagen [CTX]; P<0.0001), and this decrease was maintained through the final 1-year follow-up visit. Baseline P1NP and CTX levels correlated with extent of bone disease (P<0.0001, each) and on-treatment decreases in marker levels. Skeletal disease burden and bone-marker levels were similar between PC and BC patients, and ZOL did not significantly influence osteoprotegerin/receptor activator of nuclear factor-κB ligand levels. Only 13 SREs occurred in 11 patients, supporting the known ZOL-mediated reduction in SREs. On-treatment bone-marker level changes did not correlate with SRE rate, pain scores, or QoL. Generally, ZOL was well tolerated and adverse events were consistent with its known safety profile.CONCLUSIONS: This study confirms that ZOL therapy significantly reduces bone turnover (measured as P1NP and CTX levels) in patients with bone metastases from PC or BC.
KW - Journal Article
U2 - 10.1016/j.jbo.2012.07.002
DO - 10.1016/j.jbo.2012.07.002
M3 - SCORING: Journal article
C2 - 26909262
VL - 1
SP - 88
EP - 94
JO - J BONE ONCOL
JF - J BONE ONCOL
SN - 2212-1374
IS - 3
ER -