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JNCI Journal of the National Cancer Institute 2002 94(19):1458-1468; doi:10.1093/jnci/94.19.1458
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Journal of the National Cancer Institute, Vol. 94, No. 19, 1458-1468, October 2, 2002
© 2002 Oxford University Press


ARTICLE

A Randomized, Placebo-Controlled Trial of Zoledronic Acid in Patients With Hormone-Refractory Metastatic Prostate Carcinoma

Fred Saad, Donald M. Gleason, Robin Murray, Simon Tchekmedyian, Peter Venner, Louis Lacombe, Joseph L. Chin, Jeferson J. Vinholes, J. Allen Goas, Bee Chen
For the Zoledronic Acid Prostate Cancer Study Group

Affiliations of authors: F. Saad, Centre Hospitalier de l'Université de Montréal, Hôpital Notre-Dame, Montréal, Quebec, Canada; D. M. Gleason, Advanced Clinical Therapeutics, Tucson, AZ; R. Murray, Division of Hematology and Medical Oncology, Peter MacCallum Cancer Institute, East Melbourne, Victoria, Australia; S. Tchekmedyian, Pacific Shores Medical Group, Long Beach, CA; P. Venner, Cross Cancer Center, Edmonton, Alberta, Canada; L. Lacombe, CHUQ-Hôtel-Dieu de Quebec, Quebec, Quebec, Canada; J. L. Chin, London Health Sciences Centre, London, Ontario, Canada; J. J. Vinholes, Irmandade de Santa Casa de Misericordia de Porto Alegre, Rio Grande do Sul, Brazil; J. A. Goas, B. Chen, Novartis Pharmaceuticals Corporation, East Hanover, NJ.

Correspondence to: Fred Saad, M.D., Uro-Oncology Clinic, Centre Hospitalier de l'Université de Montréal, Hôpital Notre-Dame, 1560 Rue Sherbrooke East, Montréal, Quebec, Canada H2L 4M1 (e-mail: fred.saad{at}ssss.gouv.qc.ca).

Background: Bone metastases are a common cause of morbidity in patients with prostate carcinoma. We studied the effect of a new bisphosphonate, 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, time to the 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 zoledronic acid at 4 mg, 28% who received zoledronic acid at 8/4 mg, and 31% who received placebo completed the study. A greater proportion of patients who received placebo had skeletal-related events than those who received zoledronic acid at 4 mg (44.2% versus 33.2%; difference = –11.0%, 95% confidence interval [CI] = –20.3% to –1.8%; P = .021) or those who received zoledronic acid at 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 patients who received placebo, was not reached for patients who received zoledronic acid at 4 mg (P = .011 versus placebo), and was 363 days for those who received zoledronic acid at 8/4 mg (P = .491 versus placebo). Compared with urinary markers in patients who received placebo, urinary markers of bone resorption were statistically significantly decreased in patients who received zoledronic acid at either dose (P = .001). Pain and analgesic scores increased more in patients who received placebo than in patients who received zoledronic acid, but there were 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.



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Correspondence about this Article

Re: A Randomized, Placebo-Controlled Trial of Zoledronic Acid in Patients With Hormone-Refractory Metastatic Prostate Carcinoma
Eric Winquist and Scott Berry
J Natl Cancer Inst 2004 96: 1183. [Extract] [Full Text] [PDF]

RESPONSE: Re: A Randomized, Placebo-Controlled Trial of Zoledronic Acid in Patients With Hormone-Refractory Metastatic Prostate Carcinoma
Fred Saad
J Natl Cancer Inst 2004 96: 1183-1184. [Extract] [Full Text] [PDF]



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In Response to Jackson Letter to the Editor Regarding "Safety of Intravenous and Oral Bisphosphonates and Compliance with Dosing Regimens"
Oncologist, May 1, 2005; 10(5): 315 - 316.
[Full Text] [PDF]


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Ann OncolHome page
J. Bernhard
Timing of quality of life assessment in cancer clinical trials: fine tuning remains a challenge
Ann. Onc., April 1, 2005; 16(4): 523 - 524.
[Full Text] [PDF]


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Ann OncolHome page
K. P. Weinfurt, Y. Li, L. D. Castel, F. Saad, J. W. Timbie, G. A. Glendenning, and K. A. Schulman
The significance of skeletal-related events for the health-related quality of life of patients with metastatic prostate cancer
Ann. Onc., April 1, 2005; 16(4): 579 - 584.
[Abstract] [Full Text] [PDF]


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JNCI J Natl Cancer InstHome page
T. Grenader, L. Shavit, B. Uziely, and T. Peretz
Re: Long-Term Efficacy of Zoledronic Acid for the Prevention of Skeletal Complications in Patients with Metastatic Hormone-Refractory Prostate Cancer
J Natl Cancer Inst, February 2, 2005; 97(3): 235 - 236.
[Full Text] [PDF]


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Clin. Cancer Res.Home page
T. Yuasa, M. Nogawa, S. Kimura, A. Yokota, K. Sato, H. Segawa, J. Kuroda, and T. Maekawa
A Third-Generation Bisphosphonate, Minodronic Acid (YM529), Augments the Interferon {alpha}/ss-Mediated Inhibition of Renal Cell Cancer Cell Growth Both In vitro and In vivo
Clin. Cancer Res., January 15, 2005; 11(2): 853 - 859.
[Abstract] [Full Text] [PDF]


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JNCI J Natl Cancer InstHome page
J. E. Brown, R. J. Cook, P. Major, A. Lipton, F. Saad, M. Smith, K.-A. Lee, M. Zheng, Y.-J. Hei, and R. E. Coleman
Bone Turnover Markers as Predictors of Skeletal Complications in Prostate Cancer, Lung Cancer, and Other Solid Tumors
J Natl Cancer Inst, January 5, 2005; 97(1): 59 - 69.
[Abstract] [Full Text] [PDF]


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JNCI J Natl Cancer InstHome page
T. Tanvetyanon
Re: Long-Term Efficacy of Zoledronic Acid for the Prevention of Skeletal Complications in Patients with Metastatic Hormone-Refractory Prostate Cancer
J Natl Cancer Inst, January 5, 2005; 97(1): 70 - 70.
[Full Text] [PDF]


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The OncologistHome page
J. R. Berenson
Recommendations for Zoledronic Acid Treatment of Patients with Bone Metastases
Oncologist, January 1, 2005; 10(1): 52 - 62.
[Abstract] [Full Text] [PDF]


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The OncologistHome page
J. Berenson and R. Hirschberg
In Response to Diel I, Bergner R. Letter to the Editor of The Oncologist Re: Safety and Convenience of a 15-Minute Infusion of Zoledronic Acid
Oncologist, January 1, 2005; 10(1): 84 - 87.
[Full Text] [PDF]


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Ann OncolHome page
F. Joly and I. F. Tannock
Chemotherapy for patients with hormone-refractory prostate cancer
Ann. Onc., November 1, 2004; 15(11): 1582 - 1584.
[Full Text] [PDF]


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The OncologistHome page
C. L. Vogel, R. H. Yanagihara, A. J. Wood, F. M. Schnell, C. Henderson, B. H. Kaplan, M. H. Purdy, R. Orlowski, J. L. Decker, L. Lacerna, et al.
Safety and Pain Palliation of Zoledronic Acid in Patients with Breast Cancer, Prostate Cancer, or Multiple Myeloma Who Previously Received Bisphosphonate Therapy
Oncologist, November 1, 2004; 9(6): 687 - 695.
[Abstract] [Full Text] [PDF]


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NEJMHome page
I. F. Tannock, R. de Wit, W. R. Berry, J. Horti, A. Pluzanska, K. N. Chi, S. Oudard, C. Theodore, N. D. James, I. Turesson, et al.
Docetaxel plus Prednisone or Mitoxantrone plus Prednisone for Advanced Prostate Cancer
N. Engl. J. Med., October 7, 2004; 351(15): 1502 - 1512.
[Abstract] [Full Text] [PDF]


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JNCI J Natl Cancer InstHome page
C. C. Parker
Re: Long-Term Efficacy of Zoledronic Acid for the Prevention of Skeletal Complications in Patients With Metastatic Hormone-Refractory Prostate Cancer
J Natl Cancer Inst, October 6, 2004; 96(19): 1480 - 1480.
[Full Text] [PDF]


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Clin. Cancer Res.Home page
A. Lipton, A. Colombo-Berra, R. M. Bukowski, L. Rosen, M. Zheng, and G. Urbanowitz
Skeletal Complications in Patients with Bone Metastases from Renal Cell Carcinoma and Therapeutic Benefits of Zoledronic Acid
Clin. Cancer Res., September 15, 2004; 10(18): 6397S - 6403S.
[Abstract] [Full Text] [PDF]


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JCOHome page
I. Mancini, J.-C. Dumon, and J.-J. Body
Efficacy and Safety of Ibandronate in the Treatment of Opioid-Resistant Bone Pain Associated With Metastatic Bone Disease: A Pilot Study
J. Clin. Oncol., September 1, 2004; 22(17): 3587 - 3592.
[Abstract] [Full Text] [PDF]


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The OncologistHome page
D. Lussier, A. G. Huskey, and R. K. Portenoy
Adjuvant Analgesics in Cancer Pain Management
Oncologist, September 1, 2004; 9(5): 571 - 591.
[Abstract] [Full Text] [PDF]


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The OncologistHome page
R. E. Coleman
Bisphosphonates: Clinical Experience
Oncologist, September 1, 2004; 9(suppl_4): 14 - 27.
[Abstract] [Full Text] [PDF]


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The OncologistHome page
P. Conte and V. Guarneri
Safety of Intravenous and Oral Bisphosphonates and Compliance With Dosing Regimens
Oncologist, September 1, 2004; 9(suppl_4): 28 - 37.
[Abstract] [Full Text] [PDF]


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JNCI J Natl Cancer InstHome page
E. Winquist and S. Berry
Re: A Randomized, Placebo-Controlled Trial of Zoledronic Acid in Patients With Hormone-Refractory Metastatic Prostate Carcinoma
J Natl Cancer Inst, August 4, 2004; 96(15): 1183 - 1183.
[Full Text] [PDF]


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JNCI J Natl Cancer InstHome page
F. Saad
RESPONSE: Re: A Randomized, Placebo-Controlled Trial of Zoledronic Acid in Patients With Hormone-Refractory Metastatic Prostate Carcinoma
J Natl Cancer Inst, August 4, 2004; 96(15): 1183 - 1184.
[Full Text] [PDF]


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JNMHome page
N. Pandit-Taskar, M. Batraki, and C. R. Divgi
Radiopharmaceutical Therapy for Palliation of Bone Pain from Osseous Metastases
J. Nucl. Med., August 1, 2004; 45(8): 1358 - 1365.
[Abstract] [Full Text] [PDF]


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JNCI J Natl Cancer InstHome page
F. Saad, D. M. Gleason, R. Murray, S. Tchekmedyian, P. Venner, L. Lacombe, J. L. Chin, J. J. Vinholes, J. A. Goas, and M. Zheng
Long-Term Efficacy of Zoledronic Acid for the Prevention of Skeletal Complications in Patients With Metastatic Hormone-Refractory Prostate Cancer
J Natl Cancer Inst, June 2, 2004; 96(11): 879 - 882.
[Abstract] [Full Text] [PDF]


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The OncologistHome page
J. Berenson and R. Hirschberg
Safety and Convenience of a 15-Minute Infusion of Zoledronic Acid
Oncologist, June 1, 2004; 9(3): 319 - 329.
[Abstract] [Full Text] [PDF]


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Ann OncolHome page
D. Tripathy, M. Lichinitzer, A. Lazarev, S. A. MacLachlan, J. Apffelstaedt, M. Budde, and B. Bergstrom
Oral ibandronate for the treatment of metastatic bone disease in breast cancer: efficacy and safety results from a randomized, double-blind, placebo-controlled trial
Ann. Onc., May 1, 2004; 15(5): 743 - 750.
[Abstract] [Full Text] [PDF]


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Clin. Cancer Res.Home page
M. D. Michaelson, R. M. Marujo, and M. R. Smith
Contribution of Androgen Deprivation Therapy to Elevated Osteoclast Activity in Men with Metastatic Prostate Cancer
Clin. Cancer Res., April 15, 2004; 10(8): 2705 - 2708.
[Abstract] [Full Text] [PDF]


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The Annals of PharmacotherapyHome page
T. Tanvetyanon and A. M Choudhury
Hypocalcemia and Azotemia Associated with Zoledronic Acid and Interferon Alfa
Ann. Pharmacother., March 1, 2004; 38(3): 418 - 421.
[Abstract] [Full Text] [PDF]


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JCOHome page
E. J. Small, M. R. Smith, J. J. Seaman, S. Petrone, and M. O. Kowalski
Combined Analysis of Two Multicenter, Randomized, Placebo-Controlled Studies of Pamidronate Disodium for the Palliation of Bone Pain in Men With Metastatic Prostate Cancer
J. Clin. Oncol., December 1, 2003; 21(23): 4277 - 4284.
[Abstract] [Full Text] [PDF]


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JCOHome page
W. K. Kelly and G. Steineck
Bisphosphonates for Men With Prostate Cancer: Sifting Through the Rubble
J. Clin. Oncol., December 1, 2003; 21(23): 4261 - 4262.
[Full Text] [PDF]


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Ann OncolHome page
D. Santini, U. Vespasiani Gentilucci, B. Vincenzi, A. Picardi, F. Vasaturo, A. La Cesa, N. Onori, S. Scarpa, and G. Tonini
The antineoplastic role of bisphosphonates: from basic research to clinical evidence
Ann. Onc., October 1, 2003; 14(10): 1468 - 1476.
[Abstract] [Full Text] [PDF]


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Proc. Natl. Acad. Sci. USAHome page
G. R. Mundy
Endothelin-1 and osteoblastic metastasis
PNAS, September 16, 2003; 100(19): 10588 - 10589.
[Full Text] [PDF]



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