= Zometa zoledronic acid (a bisphosphonate) gives 4 mg dose. given intravenously in randomized phase III trial (1600 patients over 25 months) significantly more effect on bone problems than APD - 90 mg pamidronate. in breast cancer patients and patients with MM - Multiple Myeloma (Kahler) Scroll for study reports, etc. Article Update February 22, 2010

Update February 22, 2010: As early as 2004 showed a large phase III study (see below) that Zometa - zoledronic acid gives a better effect, especially on breast cancer patients than APD - pamidronate. In recent years, we have this many people, but noted only a few received Zometa - zoledronic acid required and they often disagree nkregen reimbursed. Read now in separate article how you can get Zometa or prescribed and reimbursed, and also just how you can get home Zometa administered. See how you can get home Zometa administered and how you can get just compensation through a special form.

dated January 8, 2004: Source: Medscape Pumed and several studies and put back together.

A large randomized phase III study (1600 patients followed 25 months) showed that Zometa = zoledronic acid in a dose of 4 mg. intravenously gives significantly better results compared to 90 mg. dose of pamidronate (APD) for the prevention and rehabilitation of osteoporosis in patients with breast cancer and same effect in patients with MM - Multiple Myeloma (Kahler) .

Quote from study report:
In patients with breast carcinoma, zoledronic acid (4 mg) was significantly more effective Than pamidronate, Reduce the risk of SREs by an Additional 20% (P = 0.025) compared with pamidronate and by an Additional 30% in patients receiving Hormonal therapy (P = 0.009).

It is important to know that the increasing use of chemotherapy and bone loss aromaseremmers often a problem with these additional resources to issues that are prevented. Read more about bisphosphonates on breast cancer and clodronate. and breast cancer and Bondronat .

Source: Pubmed and other medical websites like Medscape: first an interview with a professor of oncology and the study including an abstract of the study:

Narrator: In a large, randomized study of More Than 1,600 patients, 4 mg of zoledronic acid compared favorably to the standard 90-mg dose of pamidronate for the treatment of bone lesions secondary to advanced breast cancer or multiple myeloma. However, zoledronic acid was more effective Than pamidronate in lowering the risk of multiple skeletal events, Especially for Patients with advanced breast cancer. The study Findings are available in the October issue of the journal Cancer.

Dr. Julie Gralow, associate professor of Medical Oncology at the University of Washington School of Medicine and Fred Hutchinson Cancer Research Center in Seattle, Washington, said the study was designed to show the non-inferiority of zoledronic acid compared to pamidronate, Which was the standard of care at the time the study began.

Dr. Gralow: For the group as a whole, as well as if you broke out the breast cancer patients or the myeloma patients, They appeared to be quite equivalent if you Looked at, for example, the number of skeletal-related Events that occurred, the the time to first skeletal-related event, and Other Factors like that.

Narrator: In the study, patiënten Were in a randomized double-blind fashion to receive 4 or 8 mg or 90 mg or zoledronic acid or pamidronate. Because of concerns about renal toxicity, the 8 mg dose of zoledronic acid 4 mg was consistently Reduced to the trial, and the infusion time was lengthened from five minutes to 15 minutes. Originally Patients who Received the 8-mg dose Were not included in the efficacy analysis.

Received ALL patients daily oral vitamin D and calcium, had good performance status, and Were on Hormonal antineoplastic therapy or at the time of randomization. Received bisphosphonates had none in the 12 months prior to a screening visit. About 70% of the patients in the efficacy analysis had breast cancer. This 25-month study was an extension of a previous study.

The study investigators, led by Dr. Lee Rosen, director of Developmental Therapeutics at the Cancer Institute Medical Group in Santa Monica, California, used the Andersen-Gill multiple event analysis to Evaluate the risk of multiple skeletal-related events. Dr. Gralow Explains Andersen-Gill is a sensitive method for writing takingcare account the number of events as well as the time between events.

Dr. Gralow: In this case, the zoledronate Appears to be a winner. There's about a 20% reduction in this multiple-event analysis scoring with zoledronic acid versus pamidronate, and it is statistically significant. I think thats it suggests some superiority That zoledronic acid HAS Possible When we look at number of events, time to first event all factored together, in Addition to being just simply far more convenient to drip.

Narrator: Dr. Gralow, who specializes in the treatment of breast cancer, says That skeletal-related events secondary to the disease are not the only group of bone health in women with advanced breast cancer. Hormone therapy with, for example, aromatase inhibitors, puts women at risk for breast cancer with bone loss.

Dr. Gralow: The aromatase inhibitors are associated with Increased bone loss. So I think as we use more and more aromatase inhibitors, and EARLIER EARLIER, maybe just looking at it in the prevention setting, we're going to have to pay Particular attention to bone loss. After all, we're Hoping That thesisTheir breast cancer patients want to survive, so That we do have to worry about osteoporotic fractures down the line.

Narrator: Likewise, Dr. Gralow emphasizes the Importance of supportive care for women with advanced breast cancer. While bisphosphonates therapy May not extend survival, it can-ImproveGhana a patient's quality of life.

Dr. Gralow: And Clearly, that's the where clause come in for our patiënten bisphosphonates with bone mets. If We Can Prevent or Delay a skeletal-related event like a fracture or a cord compression or pain, then we've done a great service themself. So I think it's critical we provide supportive That types of therapies, Such as the bisphosphonates, bone metastases in our patiënten so That We Can Improve Their Quality of Life.

Narrator: Because zoledronic acid is infused over 15 minutes, patient and staff find it much more convenient Than pamidronate, Which HAS to be infused over 2 hours.

Dr. Gralow: Obviously, that's a huge time for a patient meta static if they're coming in everytime three to four weeks for one thesis or agents. Personally I think thats the Less Time Spent in the cream and the chemo Spent more time with the family and at home, the better. So I view it as a big convenience thing, and a lot of my patiënten do, too.

In the meta-static setting we've got newer, more potent bisphosphonates can-sacrifice That Potentially better quality of life for our patient, Fewer fractures, longer time to first fracture. In the adjuvant setting, we've got the potential for Preserving bone density. We have to sort this all out, make sure That we're in the long run, not just bone density but Preserving Preserving bone quality. Also we're looking at and bisphosphonates for Preventing Bone mets in the first place. That's the subject of clinical trials, but they're very interesting ongoing trials.

Narrator: For peer view Press, I'm Dan Keller.
Resident Medical Review
Aman Shah, MBBS
Medical Director

Peer View Press is an independent, professional medical publishing concern focused on gathering and reporting information pertaining to Clinically relevant Advances and Developments in the science and practice of medicine. Peer View Press is solely Responsible for the selection of publication topics, the preparation of editorial content and the distribution of all materials it publishes. The preparation of reports peer view is supported by educational grants subject to written agreements That Clearly stipulate and enforce the Independence of editorial peer view Press. Our reports may contain references to unapproved products or products in Certain Uses of thesis Jurisdiction. For approved prescribing information, please consult the manufacturer's product labeling. No endorsement of unapproved products or masseuses is made or implied by coverage of theses products or masseuses in our reports. No responsibility is taken for errors or Omission in reports. The production of this report was supported by an unrestricted educational grant from Novartis Oncology.

Cancer. 2003 Oct 15, 98 (8) :1735-44.

Long-term efficacy and safety of zoledronic acid compared with pamidronate disodium in the treatment of Skeletal Complications in Patients with advanced multiple myeloma or breast carcinoma: a randomized, double-blind, multicenter, comparative trial.

Rosen LS, Gordon D, Kaminski M, Howell A, Belch A, Mackey J, Apffelstaedt J, Hussein MA, Coleman RE, Reitsma DJ, Chen BL, Seaman JJ.

Developmental Therapeutics, Cancer Institute Medical Group, Santa Monica, California 90095, USA. RosenL@jwci.org

BACKGROUND: The goal of the current study was to compare the long-term (25-month) safety and efficacy of zoledronic acid with pamidronate in patient with bone lesions secondary to advanced breast carcinoma or multiple myeloma.

METHODS: Patients (n = 1648) Were randomized to receive 4 mg or 8 mg (reduced to 4 mg) zoledronic acid as a 15-minute infusion or to receive 90 mg of pamidronate as a 2-hour infusion for 24 weeks everytime 3-4 months. The primary endpoint was the Proportion of Patients with at least one skeletal-related event (SRE), defined as pathology fracture, spinal cord compression, radiation therapy, or surgery to bone. Secondary assessments included time to first SRE, skeletal morbidity rate, and multiple-event analysis. Hypercalcemia of malignancy (HCM) was included as an SRE in some secondary analysis.

RESULTS: After 25 months of follow-up, zoledronic acid Reduced the overall proportioning of Patients with an SRE and the Reduced skeletal morbidity rate similar to pamidronate. Compared with pamidronate, zoledronic acid (4 mg) Reduced the overall risk of Developing Skeletal Complications (Including HCM) by an Additional 16% (P = 0.030). In patients with breast carcinoma, zoledronic acid (4 mg) was significantly more effective Than pamidronate, Reduce the risk of SREs by anAdditional 20% (P = 0.025) compared with pamidronate and by an Additional 30% in patients receiving Hormonal therapy (P = 0.009). Zoledronic acid (4 mg) and pamidronate Were Equally well tolerated. The Most common adverse events included bone pain, nausea, and fatigue.

CONCLUSIONS: Long-term follow-up data confirm That zoledronic acid was more effective Than pamidronate in Reducing the Risk of Skeletal Complications in Patients with bone metastases from breast carcinoma and was either similar efficacy in patient with multiple myeloma. Copyright 2003 American Cancer Society.

PMID: 14534891 [PubMed - indexed for MEDLINE]

J Clin Oncol. 2001 in January 1915, 19 (2) :558-67.

Zoledronic acid is superior to pamidronate in the treatment of hypercalcemia of malignancy: a pooled analysis of two randomized, controlled clinical trials.

Major P, Lortholary A, Hon J, Abdi E, Mills G, Menssen HD, Yunus F, Bell R, Body J, Quebe-Fehling E, Seaman J.

Hamilton Regional Cancer Centre, Hamilton, Ontario, Canada. pierre.major @ hrcc.on.ca

PURPOSE: Two Identical, competitor, parallel, multicenter, randomized, double-blind, double-dummy trials Were Conducted to compare the efficacy and safety of zoledronic acid and pamidronate for treating hypercalcemia of malignancy (HCM). PATIENT AND METHODS: Patients with moderate to severe HCM (corrected serum calcium [CSC]> or = 3.00 mmol / L [12.0 mg / dL]) Were Treated with a single dose of zoledronic acid (4 or 8 mg) via 5-minute infusion or pamidronate (90 mg) by 2-hour infusion. A protocol-specified pooled analysis of the two parallel trials was Performed. Clinical end points included rate of complete response by day 10, response duration, and time to relapse. RESULTS: Two hundred eighty-seven randomized and patiënten Were Evaluated for safety, 275 Were Evaluated for efficacy. Both doses of zoledronic acid superior to pamidronate Were in the treatment of HCM. The complete response rates by day 10 Were 88.4% (P = .002), 86.7% (P = .015), and 69.7% for zoledronic acid 4 mg and 8 mg and pamidronate 90 mg, respectively. Normalization of CSC occurred by day 4 in approximately 50% of Patients Treated with zoledronic acid and in only 33.3% of the pamidronate-treated patient. The median duration of complete response Favored zoledronic acid 4 and 8 mg over pamidronate 90 mg with response durations of 32, 43, and 18 days, respectively. CONCLUSION: zoledronic acid is superior to pamidronate, 4 mg is the dose recommended for initial treatment of HCM and 8 mg for relapsed or refractory hypercalcemia.

PMID: 11208851 [PubMed - indexed for MEDLINE]