title: [Phase III clinical study of zoledronic acid in the treatment of pain induced by bone metastasis from solid tumor or multiple myeloma].
abstract: OBJECTIVE
  To evaluate the efficacy and safety of zoledronic acid in the treatment of bone pain in patients with bone metastasis from solid tumor or multiple myeloma.
  
  
  METHODS
  A randomized, double-blind, double-simulated and multi-center phase III clinical trail with pamidronate as control was conducted. Patients with moderate to severe bone pain (VAS > 50 mm) induced by solid tumor or multiple myeloma were randomized to receive intravenous zoledronic acid 4 mg or pamidronate 90 mg. Then the change of VAS and urinary NTX/Cr and CTX/Cr were observed in two groups.
  
  
  RESULTS
  From July 2005 to September 2006, 228 patients with bone pain induced by bone metastasis from 15 cancer centers were randomize into two groups: 116 patients in zoledronic acid group and 112 patients in pamidronate group. The VAS value was decreased gradually after treatment in these two groups. Significant improvement in bone pain after treatment were observed both in zoledronic acid group and the control group when compared with baseline VAS on D8 (-11.77% vs. -10.87%), D15 (-24.60% vs. -21.06%) and D28 (-32.37% vs. -31.26%) (P< or =0.0001), but no significant difference existed between two groups (P =0.6587). Compared with baseline, urine NTX/Cr and CTX/Cr level were decreased rapidly after treatment in both groups, the nadir was on D8, the median decreased on D28, which was -36.9% vs. -32.1% for NTX/Cr (P = 0.7922) and -63.2% vs. -47.9% for CTX/Cr (P =0.834). The frequently observed adverse events were pyrexia (19.0% vs. 31.3%), vomiting (6.0% vs. 8.9%), nausea (4.3% vs. 4.5%), fatigue (3.4% vs. 2.7%) and constipation (2.6% vs. 1.8%) in the two groups. Compared with baseline, the serum creatinine level was not significantly increased throughout the study.
  
  
  CONCLUSIONS
  Intravenous injection of 4 mg zoledronic acid can significantly reduce bone pain and bone resorption marker in urine in the Chinese patients with bone metastasis from solid tumor or multiple myeloma, which is tolerable and also comparable to pamidronate in the efficacy and safety.
authors.affiliation: Department of Medical Oncology, Cancer Hospital (Institute), Chinese Academy of Medical Sciences, Beijing 100021, China.
authors.forename: Mei
authors.initials: M
authors.lastname: Dong
authors.forename: Feng-Yi
authors.initials: FY
authors.lastname: Feng
authors.forename: Yang
authors.initials: Y
authors.lastname: Zhang
authors.forename: Guang-Ru
authors.initials: GR
authors.lastname: Xie
authors.forename: Ya-Jie
authors.initials: YJ
authors.lastname: Wang
authors.forename: Ji-Wei
authors.initials: JW
authors.lastname: Liu
authors.forename: San-Tai
authors.initials: ST
authors.lastname: Song
authors.forename: Qing-Hua
authors.initials: QH
authors.lastname: Zhou
authors.forename: Jun
authors.initials: J
authors.lastname: Ren
authors.forename: Shun-Chang
authors.initials: SC
authors.lastname: Jiao
authors.forename: Jin
authors.initials: J
authors.lastname: Li
authors.forename: Xiu-Wen
authors.initials: XW
authors.lastname: Wang
authors.forename: Qiang
authors.initials: Q
authors.lastname: Chen
authors.forename: Zhe-Hai
authors.initials: ZH
authors.lastname: Wang
authors.forename: Nong
authors.initials: N
authors.lastname: Xu
authors.forename: Ji-Feng
authors.initials: JF
authors.lastname: Feng