= Zometa zoledronic acid (a bisphosphonate) Information: Zometa provides significantly better results in randomized phase III study in patients with recurrent prostate cancer and as an addition to hormone treatments.

March 22, 2005: Source: J Natl Cancer Inst. Oct 2 2002, 94 (19) :1458-68.

Earlier we had published this study but can not easily find on the site and also belongs to all information on Zometa - zoledronic acid to stand. So here again, and references to the abstract discussion in major medical journals on Zometa and effect in prostate cancer patients.

Comment in:
BJU Int. April 2003, 91 (6) :464-5.
J Natl Cancer Inst. Oct 2 2002, 94 (19) :1422-3.
J Natl Cancer Inst. 6 August 2003, 95 (15) :1174-5, author reply 1175.
J Natl Cancer Inst. 2003 in February 1919, 95 (4) :332-3, author reply 333-4.
J Natl Cancer Inst. 2003 in February 1919, 95 (4): 332, author reply 333-4.
J Natl Cancer Inst. 2003 in February 1919, 95 (4): 332, author reply 333-4.
J Natl Cancer Inst. 2004 August 4, 1996 (1915): 1183, author reply 1183-1184.
J Natl Cancer Inst. 2004 Oct 6, 1996 (1919): 1480, author reply 1480-1.
J Natl Cancer Inst. 2 February 2005, 97 (3) :235-6.

A randomized, placebo-controlled trial of zoledronic acid in patient with hormone-refractory prostate carcinoma meta-static.

Saad F, Gleason DM, Murray R, Tchekmedyian S, Venner P, Lacombe L, Chin JL, Vinholes JJ Goas JA, Chen B, zoledronic Acid Prostate Cancer Study Group. Uro-Oncology Clinic, Centre Hospitalier de l'Université de Montréal, Hopital Notre-Dame, Montreal, Quebec, Canada. fred.saad @ ssss.gouv.qc.ca

BACKGROUND: Bone metastases are a common cause of morbidity in patient with prostate carcinoma. We studied the effect of a new bisphosphonates, zoledronic acid, Which blocks bone destruction, on Skeletal Complications in prostate cancer patients with bone metastases. METHODS: Patients with hormone-refractory prostate cancer and a history of bone metastases Were Randomly Assigned to a double-blind treatment regimen of intravenous zoledronic acid at 4 mg (N = 214), zoledronic acid at 8 mg (subsequently Reduced to 4 mg; 8 / 4) (N = 221), or placebo (N = 208) every 3 weeks for 15 months. Proportions of Patients with skeletal-related events, the time to first skeletal-related event, skeletal morbidity rate, pain and Analgesic scores, disease progression, and safety Were assessed. All statistical tests Were two-sided.

RESULTS: Approximately 38% of Patients who Received at zoledronic acid 4 mg, 28% who Received zoledronic acid at 8 / 4 mg, and 31% Received placebo who completed the study. A Greater Proportion of Patients who Received placebo had skeletal-related events Than Those Who Received at 4 mg zoledronic acid (44.2% versus 33.2%, difference = -11.0%, 95% confidence interval = 2,079,702,307 -20.3% to -1.8%, P =. 021) or zoledronic acid at Those Who Received 8 / 4 mg (38.5% difference versus placebo = -5.8%, 95% CI = -15.1% to 3.6%, P =. 222). Median time to first skeletal-related event was 321 days for Patient who Received placebo was not Reached for Patient who Received at zoledronic acid 4 mg (P =. 011 vs placebo), and was 363 days for Those Who Received zoledronic acid at 8 / 4 mg (P =. 491 vs. placebo). Compared with urinary markers in Patients who Received placebo, urinary markers of bone resorption statistically significantly Were Decreased in Patients who Received Either at zoledronic acid dose (P =. 001). Pain and Analgesic Scores Increased in Patients who Received placebo more Than in Patients who Received zoledronic acid, but Were there no differences in disease progression, performance status, or quality-of-life scores among the groups. Zoledronic acid at 4 mg Given as a 15-minute infusion was well tolerated, but the 8-mg dose was associated with renal function Deterioration.

CONCLUSION: zoledronic acid at 4 mg Reduced skeletal-related events in prostate cancer patients with bone metastases. PMID: 12359855 [PubMed - indexed for MEDLINE]