Abstract | BACKGROUND & OBJECTIVE: 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. CONCLUSION: Zoledromic acid is effective and safe in treating metastatic bone pain of patients with malignancy, which is similar to pamidranate.
|
Authors | Gong Zhang, Wei Cai, Yun-Feng Zhou, Pei-Wen Li, Ya-Jie Gao, Yang Zhang, Shun-Jin Wang, Guo-Guang Mao, Bing Liu |
Journal | Ai zheng = Aizheng = Chinese journal of cancer
(Ai Zheng)
Vol. 24
Issue 12
Pg. 1489-92
(Dec 2005)
China |
PMID | 16351798
(Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial)
|
Chemical References |
- Bone Density Conservation Agents
- Diphosphonates
- Imidazoles
- Mannitol
- Zoledronic Acid
- Pamidronate
|
Topics |
- Adult
- Aged
- Bone Density Conservation Agents
(therapeutic use)
- Bone Neoplasms
(complications, drug therapy, secondary)
- Diphosphonates
(therapeutic use)
- Double-Blind Method
- Female
- Humans
- Imidazoles
(therapeutic use)
- Male
- Mannitol
(therapeutic use)
- Middle Aged
- Pain, Intractable
(drug therapy, etiology)
- Pamidronate
- Prospective Studies
- Zoledronic Acid
|