[Phase II randomized clinical trail of zoledronic acid in treating metastatic bone pain of malignancy].
OBJECTIVE
Bone metastases are the prevailing reason for pain in patients with malignancies, which seriously affect their life quality. Zoledronic acid, the third generation of bisphosphonates, can inhibit the activity of osteoclasts and relieve pain. This study was to evaluate the efficacy and safety of zoledronic acid in treating metastatic bone pain for patients with malignancies.


METHODS
A multi-center, randomized, double-blind, and prospective trail was conducted. Patients with metastatic bone pain were randomized to receive zoledromic acid plus monnitol, or pamidronate plus monnitol as positive control.


RESULTS
From Oct. 2003 to Oct. 2004, 216 patients with metastatic bone pain were randomized into 2 groups: 109 in zoledromic acid group, and 107 in pamidronate group. There was no significant difference in pain intensity (PI) between zoledromic acid group and pamidronate group before treatment (6.0+/-1.1 vs. 6.0+/-1.3, P=0.938), 7 days after treatment (3.7+/-1.99 vs. 4.1+/-2.0, P=0.119), and 14 days after treatment (3.2+/-2.0 vs. 3.7+/-2.4, P=0.129). The differences in complete response (CR) rate, partial response (PR) rate, and total response rate between the 2 groups were not significant (10.4% vs. 9.5%, 69.8% vs. 69.5%, 88.7% vs. 85.7%, P>0.05). Time to CR was significantly shorter in zoledromic acid group than in pamidronate group [(7.0+/-2.2) days vs. (9.5+/-2.6) days, P=0.033]; the differences in time to PR, duration of CR, and duration of PR between the 2 groups were not significant [(4.9+/-2.6) days vs. (5.0+/-2.5) days, P=0.908; (13.2+/-1.80) days vs. (14.0+/-0.0) days, P=0.155; and (13.4+/-1.9) days vs. (12.8+/-2.8) days, P=0.127]. The main adverse events were fever, nausea, vomiting, and general malaise. The occurrence and severity of adverse events were similar between the 2 groups.


CONCLUSIONS
Zoledromic acid is effective and safe in treating metastatic bone pain of patients with malignancy, which is similar to pamidranate.
Zhang
Gong
G
Department of Radiotherapy & Chemotherapy, Zhongnan Hospital, Wuhan University, Wuhan, Hubei 430071, P. R. China.
Cai
Wei
W
Zhou
Yun-Feng
YF
Li
Pei-Wen
PW
Gao
Ya-Jie
YJ
Zhang
Yang
Y
Wang
Shun-Jin
SJ
Mao
Guo-Guang
GG
Liu
Bing
B
D000328:Adult; D000368:Aged; D050071:Bone Density Conservation Agents / Q000627:therapeutic use*; D001859:Bone Neoplasms / Q000150:complications / Q000188:drug therapy* / Q000556:secondary; D004164:Diphosphonates / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007093:Imidazoles / Q000627:therapeutic use*; D008297:Male; D008353:Mannitol / Q000627:therapeutic use; D008875:Middle Aged; D010148:Intractable Pain / Q000188:drug therapy* / Q000209:etiology; D000077268:Pamidronate; D011446:Prospective Studies; D000077211:Zoledronic Acid
D050071:Bone Density Conservation Agents; D004164:Diphosphonates; D007093:Imidazoles; D008353:Mannitol; D000077211:Zoledronic Acid; D000077268:Pamidronate