title: Comparison between zoledronic acid and clodronate in the treatment of prostate cancer patients with bone metastases.
abstract: The aim of this study is to compare the efficacy and safety between zoledronic acid (ZA) and clodronate (CA) in the treatment of bone metastases for prostate cancer patients. We conducted a prospective study in recruiting 137 prostate cancer patients with bone metastases from 2008 to 2010. All men were well responding to first-line hormone therapy (PSA < 2 ng/mL); Patients were randomly assigned to receive zoledronic acid (4 mg over a 30 min infusion) every 1 month or to take 4 tablets per day of clodronate (1,600 mg) for up to 3 years. Bone mineral density (BMD) was measured by dual-energy X-ray absorptiometry at femoral neck, lumbar spine, and total hip, together with visual analog scale score were evaluated on baseline and 6, 12, 24, and 36 months, respectively. Toxicity and skeletal-related events (SREs) happened in both groups during this period were recorded down and compared. The ZA group had better bone progression-free survival (BPFS) (31 months vs 22 months, P = 0.04), but no statistical evidence of benefit was observed in terms of overall survival rate. The ZA group significantly increased lumbar spine BMD (4.5 ± 2.3 % vs CA group 2.3 ± 3.9 % P = 0.03), had a better response on pain-relieve effect (92 vs 76 % P = 0.002) and a rapid pain palliation (9 months vs 13 months P = 0.03). The CA group reported more gastrointestinal cases. However, the ZA group required more dose modifications. As compared to clodronate, Zoledronic acid has advantages on extending BPFS, better bone pain control and lumbar spine BMD performance for prostate cancer patients with bone metastases. The overall survival rate and SREs rate are similar.
authors.affiliation: Department of Urology, First Affiliated Hospital of Wenzhou Medical College, ShangCai Village, Wenzhou, Ou Hai District, Zhejiang 325000, People's Republic of China. fengyuan-@163.com
authors.forename: Feng
authors.initials: F
authors.lastname: Wang
authors.forename: Wei
authors.initials: W
authors.lastname: Chen
authors.forename: Hongde
authors.initials: H
authors.lastname: Chen
authors.forename: Licai
authors.initials: L
authors.lastname: Mo
authors.forename: Haiyong
authors.initials: H
authors.lastname: Jin
authors.forename: Zhixian
authors.initials: Z
authors.lastname: Yu
authors.forename: Chengdi
authors.initials: C
authors.lastname: Li
authors.forename: Qing
authors.initials: Q
authors.lastname: Liu
authors.forename: Feifei
authors.initials: F
authors.lastname: Duan
authors.forename: Zhiliang
authors.initials: Z
authors.lastname: Weng
mesh_terms: D000368:Aged; D015519:Bone Density / Q000187:drug effects; D001859:Bone Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000556:secondary; D004002:Clodronic Acid / Q000627:therapeutic use*; D004164:Diphosphonates / Q000627:therapeutic use*; D018572:Disease-Free Survival; D006801:Humans; D007093:Imidazoles / Q000627:therapeutic use*; D008297:Male; D011446:Prospective Studies; D011471:Prostatic Neoplasms / Q000188:drug therapy* / Q000473:pathology; D015996:Survival Rate; D000077211:Zoledronic Acid
chemical_list: D004164:Diphosphonates; D007093:Imidazoles; D004002:Clodronic Acid; D000077211:Zoledronic Acid