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ZOMETA injection - Proven Efficacy in Patients with Bone Metastases from:
The First IV Bisphosphonate
Proven Effective for Patients with Documented Bone Metastases
from Prostate Cancer[1,2]
In prostate cancer, ZOMETA significantly delayed bone complications vs. placebo by over 5 months (P=0.009)[3]
Patients taking ZOMETA had significantly fewer skeletal-related events.[1,2]
Prostate cancer should have progressed after treatment with at least one hormonal therapy.
Study design: Phase III, randomized, double-blind, placebo-controlled, international, multicenter (136), 15-month parallel study (039) in 422 prostate cancer patients (n=214 receiving ZOMETA, n=208 taking placebo every 3 weeks) with metastatic bone lesions and 3 consecutive rising serum PSA levels and receiving antineoplastic therapy. More than 90% of patients were >60 years of age.
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Proven Efficacy in Patients with Multiple Myeloma and Patients with Documented Bone Metastases from Breast Cancer[1,2,4]
Study design: Phase III, randomized, double-blind, double-dummy,
international, multicenter, 12-month parallel study
(010) in 1,122 patients stratified by cancer type and
breast cancer treatment (Stage III multiple myeloma;
stage IV breast cancer on chemotherapy, with or without
hormonal therapy; stage IV breast cancer receiving first-
or second-line hormonal therapy for metastatic disease).
564 patients received ZOMETA 4 mg, and 558 patients
received pamidronate disodium 90 mg every 3 to 4 weeks;
all patients were evaluated at Month 13.
. 
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In a recent Japanese study, ZOMETA significantly reduced skeletal complications in women with bone metastases from breast cancer versus placebo.[5]
Proportion of patients with each type of skeletal-related event (SRE). Comp, compression; HCM, hypercalcemia of malignancy. (*), excluding HCM.
Study design: Women with bone metastases from breast cancer were randomized to receive 4 mg zoledronic acid (n=114) or placebo (n=114) every 4 weeks for one year.
Results: The risk of skeletal-related event (SRE), defined as pathologic fracture, spinal cord compression, and radiation or surgery to bone, was reduced 39% compared to placebo (P=.027).
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The First Bisphosphonate Proven Effective in Patients with Documented Bone Metastases from Solid Tumors*[1,2]
| Solid tumor types included in study |
| Non-small cell lung cancer |
48% |
| Renal |
9% |
| Small cell lung cancer |
8% |
| Colorectal |
7% |
| Unknown |
6% |
| Bladder |
5% |
| GI (other) |
4% |
| Head and neck |
2% |
| Genitourinary |
2% |
| Malignant melanoma |
2% |
| Hepatobiliary |
1% |
| Thyroid |
1% |
| Sarcoma |
1% |
| Neuroendocrine/carcinoid |
<1% |
| Mesothelioma |
<1% |
| Other |
<1% |
Study design: Phase III, randomized, double-blind, placebo-controlled,
international, multicenter (141), 9-month parallel study (011) in
507 patients with any cancer other than breast, prostate or multiple
myeloma, and with bone metastases; ZOMETA given with concomitant
antineoplastic therapy (n=257 receiving ZOMETA, n=250 receiving
placebo every 3 weeks)
In other solid tumors, including non-small cell lung cancer, ZOMETA significantly delayed bone complications vs. placebo by over two months (P=.023).[1,6]
Read more about the safety of ZOMETA.
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- ZOMETA full prescribing information. Novartis Pharmaceuticals Corporation, 2002.
- Data on file (ISE/ISS). Novartis Pharmaceuticals Corporation.
- Saad F, Gleason DM, Murray R, et al. Long-term efficacy of zoledronic acid for the prevention of skeletal complications in patients with metastatic hormone-refractory prostate cancer. J Natl Cancer Inst . 2004;96(11):879-82.
- Rosen LS, Gordon D, Kaminski M, et al. Zoledronic acid versus pamidronate in the treatment of skeletal metastases in patients with breast cancer or osteolytic lesions of multiple myeloma: a phase III, double-blind, comparative trial. Cancer J. 2001;7(5):377-387.
- Kohno N, Aogi K, Minabi H, et al. Zoledronic acid significantly reduces skeletal complications compared with placebo in Japanese women with bone metastases from breast cancer: a randomized, placebo-controlled trial. J Clin Oncol. 2005; 23: 1-8.
- Rosen LS, Gordon D, Tchekmedyian S, et al. Zoledronic acid versus placebo in the treatment of skeletal metastases in patients with lung cancer and other solid tumors: a phase III, double-blind, randomized trial--the Zoledronic Acid Lung Cancer and Other Solid Tumors Study Group. J Clin Oncol. 2003; 21:3150-7.
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